The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials.

INTRODUCTION: Older patients with cancer range from fit to frail with various comorbidities and resilience to chemotherapy. Besides nausea and fatigue, a significant number of patients experience dizziness and impaired walking balance after chemotherapy, which can have great impact on their functional ability and health related quality of life. Symptoms are easily overlooked and therefore often underreported and managed, which is why symptoms could end up as long-lasting side effects. The aim of this study is to investigate the development of dizziness, decline in walking balance, and sarcopenia and the effect of a comprehensive geriatric assessment and 12 weeks of group-based exercise on these symptoms. The exercise intervention includes vestibular and balance exercises, and progressive resistance training, to counteract the symptoms in older patients with colorectal cancer treated with chemotherapy. MATERIALS AND METHODS: This is a randomized controlled trial including patients ≥65 years initiating (neo)adjuvant or first-line palliative chemotherapy for colorectal cancer. Patients will undergo a comprehensive assessment program including measures of vestibular function, balance, muscle strength, mass, and endurance, peripheral and autonomic nerve function, and subjective measures of dizziness, concern of falling, and health related quality of life. Tests will be performed at baseline, 12, and 24 weeks. Patients will be placed in three different randomized controlled trials depending on chemotherapy regimen and randomized 1:1 to comprehensive geriatric assessment and exercise three times/week or control. Participants in both groups will continue with usual care, including standardized oncological treatment. In total, 150 patients are needed to assess the two primary outcomes of (1) maintenance of walking balance assessed with Dynamic Gait Index and (2) lower limb strength and endurance assessed with 30 Second Sit-to-Stand Test at 12 weeks. The primary outcomes will be analyzed using a mixed linear regression model investigating the between-group differences. DISCUSSION: Trial enrollment began in April 2023 and is the first trial to evaluate reasons for dizziness, decline in walking balance, and sarcopenia in older patients receiving chemotherapy. The trial will provide new and valuable knowledge in how to assess, manage, and prevent dizziness, decline in walking balance, and sarcopenia in older patients with colorectal cancer. TRIAL REGISTRATION: The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).

Impact of FRAilty screening and Geriatric assessment and INtervention in older patients with epithelial Ovarian Cancer: A multicenter randomized clinical trial protocol (FRAGINOC).

INTRODUCTION: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). MATERIALS AND METHODS: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. DISCUSSION: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.

Geriatric screening and frailty intervention in older patients with cancer.

Frailty in older patients with cancer increases the risk of treatment related toxicity, mortality, physical decline, and quality of life. This review summarises various screening tools. Screening tools identifying frailty serve multiple purposes, providing awareness of health issues impacting oncologic treatment and prognosis and facilitating the delivery of a Comprehensive Geriatric Assessment (CGA). CGA is an overall health assessment and treatment targeting frailty. Providing CGA to older patients with cancer reduces the risk of toxicity and functional decline, increases treatment completion, and prevents loss of quality of life.

Effects of comprehensive geriatric assessment-guided interventions on physical performance and quality of life in older patients with advanced cancer: A randomized controlled trial (PROGNOSIS-RCT).

INTRODUCTION: Older patients with frailty starting oncological treatment are at higher risk of experiencing declining physical performance, loss of independence, and quality of life (QoL). This study examines whether comprehensive geriatric assessment (CGA)-guided interventions added to standard oncological care can prevent declining physical performance and QoL in older patients with frailty initiating palliative treatment. MATERIALS AND METHODS: Patients aged ≥70 years, with a Geriatric-8 score of ≤14, initiating palliative oncological treatment were enrolled in an open label randomized controlled trial and randomized 1:1 to receive either CGA-guided interventions in addition to oncological standard care or oncological care alone. Baseline characteristics, physical performance measures, and QoL questionnaires were retrieved before group allocation. CGA was performed using a fixed set of domains and validated tests by a geriatrician-led team. The primary endpoint, physical performance, was measured by the 30-s chair stand test (30s-CST) at three months. Additional outcomes included 30s-CST at six months, handgrip strength test, and QoL. Outcomes were analyzed using linear mixed regression models. The trial was registered at clinicaltrials.org (NCT04686851). RESULTS: From November 1, 2020 to May 31, 2022, 181 patients were included; 88 in the interventional arm and 93 in the control arm. Median age was 77 (interquartile range [IQR] 73-81) years, 69% were male, median Geriatric-8 score was 12 (IQR 10-13), 69% had a Performance Status of 0-1, and the median 30s-CST was 9 (IQR 5-11) repetitions. The between-group difference in 30s-CST at three months was 0.67 (95%CI: -0.94 - 2.29) and 1.57 (95%CI: -0.20 - 3.34) at six months, which were not statistically significant. Subgroup analysis including participants with a baseline Geriatric-8 of 12-14 found borderline significant between-group differences in 30s-CST scores at three and six months of 2.04 (95% confidence interval [CI]: -0.07 - 4.2, P = 0.06) and 2.25 (95%CI: 0.01-4.5, P = 0.05), respectively. No within-group or between-group differences in the summary score or the Elderly Functional Index score (measuring QoL) were found. DISCUSSION: This study did not find significant between-group differences in the 30s-CST in older patients receiving palliative care. However, a tendency towards improved physical performance was seen in the least frail. These patients may represent a target group wherein CGA interventions provide particular benefit.

Preoperative plasma vitamin D in patients with localized colorectal cancer: Age-dependent association with inflammation, postoperative complications, and survival.

INTRODUCTION: Aging is often associated with low-grade chronic inflammation and a senescent immune system. Vitamin D is a regulator of immune function, and low plasma vitamin D is associated with poor health. The association between plasma vitamin D and inflammatory biomarkers and risk of postoperative complications and survival in patients with colorectal cancer (CRC) is unknown. Our aim was to investigate these associations and how they are influenced by age. MATERIALS AND METHODS: Circulating vitamin D and the inflammatory biomarkers C-reactive protein (CRP), interleukin (IL)-6, and YKL-40 were measured in 398 patients with stage I-III CRC preoperatively. Older patients (≥70 years, n = 208) were compared to younger patients (<70 years, n = 190). The relation between vitamin D and complications and high inflammatory biomarker levels was presented by odds ratios ([OR], 95% confidence interval [CI]). Associations with survival were presented with hazard ratios ([HR], 95% CI). RESULTS: Plasma vitamin D was higher in older patients than in younger patients (75 vs. 67 nmol/L, P = 0.001). High vitamin D was associated with low plasma CRP in younger patients (OR = 0.35, 95% CI 0.17-0.76), but not in older patients (OR = 0.93, 0.49-1.76). High vitamin D in older patients with CRC was associated with reduced risk of major complications (OR = 0.52, 0.28-0.95). This was not found in younger patients (OR = 1.47, 0.70-3.11). Deficient vitamin D (<25 nmol/L) was associated with short overall survival compared to sufficient (>50 nmol/L) irrespective of age (HR = 3.39, 1.27-9.37, P = 0.02). CONCLUSION: For patients with localized CRC, high vitamin D levels before resection were associated with reduced risk of high inflammatory biomarkers for younger patients and reduced risk of major postoperative complications for older patients. Vitamin D deficiency was associated with reduced survival regardless of age.

The prevalence of sarcopenia and cachexia in older patients with localized colorectal cancer.

INTRODUCTION: The incidence of colorectal cancer (CRC) increases with age. In combination with an ageing population, the number of older patients undergoing surgical treatment for CRC is therefore expected to increase. Sarcopenia and cachexia are potentially modifiable risk factors of a negative surgical outcome. Sarcopenia can be categorized into primary (age-related) and secondary where diseases, such as malignancy, are influential factors. We aimed to investigate the prevalence of preoperative sarcopenia and cachexia in older (≥65 years) vulnerable patients with localized CRC. MATERIALS AND METHODS: Patients included in the randomized study "Geriatric assessment and intervention in older vulnerable patients undergoing resection for colorectal cancer," were screened for sarcopenia and cachexia prior to surgery. All patients in the present cohort were considered vulnerable with Geriatric 8 ≤ 14 points. Sarcopenia was defined according to European Guidelines (EWGSOP2), based on low muscle strength-low handgrip-strength and/or slow 5xChair-Stand-Test-and low appendicular lean mass assessed by dual-energy X-ray absorptiometry. Cachexia was defined as self-reported unintended weight loss >5% within three months or 2-5% with body mass index <20 kg/m2. RESULTS: Sixty-four patients (mean age 79.6 years ±6.4 years, 36 women) were assessed. Of these, 28% (n = 18, 11 women) had low muscle strength and 13% (n = 8, 4 women) fulfilled the criteria for sarcopenia, however, 33% (n = 21, 13 women) had low muscle mass. There was no correlation between low muscle strength and low muscle mass (r = 0.16, P = 0.22). The prevalence of cachexia was 36% (n = 23, 16 women). Low muscle mass was associated with cachexia (φ = 0.38, P = 0.005), but there was no association between sarcopenia and cachexia (φ = 0.01, P = 1.0). DISCUSSION: Despite the included patients who fulfilled the criteria for vulnerability according to G8, relatively few (28%) had low muscle strength. Moreover, there was poor overlap between the prevalence of sarcopenia according to the EWGSOP2 guidelines (13%) and prevalence of low muscle mass (33%) in older patients with CRC. Of note also, there was no association between sarcopenia and cachexia, but an association between cachexia and low muscle mass, which highlights the importance of assessing muscle mass in patients with cancer. TRIAL REGISTRATION: The GEPOC trial has been prospectively registered at http://clinicaltrials.gov (NCT03719573).

Physical exercise program to older frail patients receiving chemotherapy for colorectal cancer - feasibility and experiences from the GERICO study.

INTRODUCTION: Older and frail patients with cancer are at high risk of physical and functional decline during chemotherapy. Exercise interventions can often counteract chemotherapy related toxicity and may help patients to improve or retain physical function and quality of life. Studies evaluating feasibility and the effect of exercise in older patients are lacking. The aim of this study was to investigate the feasibility and effect of an exercise intervention in older frail patients during chemotherapy for colorectal cancer (CRC). MATERIALS AND METHODS: This is a secondary analysis from the GERICO study investigating the effect of geriatric interventions in frail patients ≥70 years receiving chemotherapy for CRC. All patients in the present analysis were patients randomized to geriatric interventions and who were found physically frail (low handgrip strength or slow 10 m gait speed) and therefore offered referral to the exercise program for twelve weeks. We evaluated reasons for dropping out and feasibility of an individually tailored exercise program twice a week for twelve weeks. Each 60 min session comprised warm-up followed by progressive resistance training and cool-down followed by an oral protein supplement. Baseline characteristics and the effect of exercise for patients with high and low adherence (attendance of <50% of exercise sessions) were compared. RESULTS: Of 71 patients in the intervention group, 47 (66%) were found physically frail and were offered referral to the exercise program. Seven patients were referred to municipal physiotherapy before study start. In the remaining population (N = 40) 19 had exercise adherence >50% and 21 had no or low exercise adherence. Baseline characteristics were similar between patients with high and low/no adherence, except for sex (68% and 33% were men in high and low/ no adherence group, respectively). Patients with >50% attendance had significant improvements in physical tests after twelve weeks of exercise. DISCUSSION: Low adherence to the exercise program was seen due to lack of energy and/or treatment related adverse events. Patients with high adherence benefitted from exercise during chemotherapy but did not differ from patients with low adherence at baseline. Consequently, exercise should be offered to all older frail patients receiving chemotherapy for CRC.

Muscle mass and physical function in patients with bladder cancer-Data from a prematurely terminated prospective cohort study.

Background: Patients with bladder cancer (BC) have a high prevalence of comorbidity and low adherence to systemic anticancer treatment but it is unknown whether this is associated with sarcopenia. Objective: We aimed to investigate if the sarcopenia-defining parameters (muscle strength, muscle mass and physical performance) were associated with reduced adherence to systemic anticancer treatment in patients with BC, and if these muscle domains changed during treatment. Methods: Patients >18 years of age with BC referred for chemotherapy or immunotherapy at Department of Oncology, Rigshospitalet, Denmark were eligible for study inclusion. Measurements were performed before treatment initiation and within one week after treatment termination, and consisted of assessments of muscle strength, muscle mass, and physical performance. Data was compared with thresholds outlined by the European Working Group on Sarcopenia in Older Patient's (EWGSOP2) guidelines and a healthy, age-matched Danish cohort. Results: Over a period of 29 months, we included 14 patients of whom two completed follow-up measurements. The recruitment rate was <50% of planned due to logistics and Covid-19 related limitations. Consequently, a decision to prematurely terminate the study was made. No patients fulfilled EWGSOP2 criteria for sarcopenia, but the majority had reduction in one or more muscle domains compared to healthy, age-matched individuals. The majority of patients had poor treatment tolerance, leading to dose reductions and postponed treatments. Conclusions: In this prematurely terminated study, no patients fulfilled EWGSOP2 criteria for sarcopenia, yet, most patients were affected in one or more muscle domains and the majority had compromised treatment adherence.

Effectiveness of different types, delivery modes and extensiveness of exercise in patients with breast cancer receiving systemic treatment - A systematic review and meta-analysis.

BACKGROUND: Effects of exercise in patients with breast cancer have been thoroughly investigated. The aim was to explore differences in effects regarding type, delivery mode and extensiveness (e.g. intensity; volume) of the interventions. METHODS: We searched for randomised controlled trials including patients with breast cancer receiving systemic treatment, exercise-based interventions, and measures on patient reported- and objectively measured outcomes. RESULTS: Exercise showed significant and moderate effects on the primary outcomes quality of life and physical function, Standardised Mean Difference: 0.52 (95 % CI 0.38-0.65) and 0.52 (95 % CI 0.38-0.66), respectively. Type of exercise had little influence on the effects, however combined aerobic- and resistance exercise seemed superior for increasing physical function, compared to aerobic or resistance exercise. Supervised interventions were superior to partly and unsupervised. Extensiveness of the intervention only influenced physical function. CONCLUSIONS: Supervised interventions, more than type or extensiveness of interventions, seem to increase effects.

Reasons for lack of treatment in patients with locally advanced, unresectable or metastatic urothelial carcinoma.

BACKGROUND: The proportion of patients with locally advanced, unresectable or metastatic urothelial carcinoma that do not receive systemic anticancer treatment and the reasons for lack of treatment are largely unknown. The aim of this study was to investigate the prevalence and overall survival of this patient group and reasons for omission of treatment. MATERIAL AND METHODS: This retrospective, single-center cohort study from Rigshospitalet, Denmark included patients diagnosed with locally advanced, unresectable or metastatic urothelial carcinoma during the study period from 1 January 2010 to 31 March 2016 who did not receive systemic anticancer treatment. Patients were identified through the Danish Pathology Register and the electronic medical records. RESULTS: 100 patients were included, representing 34% of all patients diagnosed with locally advanced, unresectable or metastatic urothelial carcinoma at Rigshospitalet during the study period. Lack of treatment was most often due to poor physical condition (59%), decreased renal function (15%), or patient preferences (14%). Median overall survival was 1.9 months (95% CI: 1.6-2.8 months). CONCLUSION: One in three patients diagnosed with locally advanced, unresectable or metastatic urothelial carcinoma in the pre-immunotherapy era did not receive systemic anticancer treatment. Prompt identification of advanced disease and interventions to optimize these patients for treatment are essential. Our findings underscore the compelling need for novel, better tolerated treatment regimens in this frail patient group.

Geriatric assessment in the management of older patients with cancer - A systematic review (update).

AIM: The aim of this systematic review is to summarize all available data on the effect of a geriatric assessment in older patients with cancer, for oncologic treatment decisions, the implementation of non-oncologic interventions, patient-doctor communication, and treatment outcome. Additionally, we examined the impact of the type of assessment used. METHODS: Systematic Medline and Embase search for studies on the effect of a geriatric assessment on oncologic treatment decisions, non-oncologic interventions, communication, and outcome. RESULTS: Sixty-five publications from 61 studies were included. After a geriatric assessment, the oncologic treatment plan was altered in a median of 31% of patients (range 7-56%), with highest change rates in studies using a multidisciplinary team evaluation. Non-oncologic interventions were recommended in over 70% of patients, provided that an intervention plan or specific expertise was in place. A geriatric assessment led to more goals-of-care discussions and improved communication. The geriatric assessment also led to lower toxicity/complication rates (most strongly if the assessment outcomes were considered during decision making), improved likelihood of treatment completion, and improved physical functioning and quality of life in the majority of included studies. CONCLUSION: A geriatric assessment can change oncologic treatment plans, leads to non-oncologic interventions, and improve communication about care planning and ageing-related issues. It can decrease toxicity/complications and improve treatment completion and patient-centred outcomes. If multidisciplinary or geriatric input is not available, having a pre-defined non-oncologic intervention plan is important. To maximize the effect on outcomes, the result of the geriatric assessment should be incorporated into oncologic decision-making.

Age-related Differences in Recall of Information and Handling of Chemotherapy-related Side Effects in Cancer Patients: The ReCap Study.

BACKGROUND: To prevent severe toxicity and hospital admissions, adequate management and recall of information about side effects are crucial and health literacy plays an important role. If age-related factors impact recall of given information and handling of side effects, revised ways to give information are required. PATIENTS AND METHODS: We undertook a questionnaire-based survey among 188 newly diagnosed patients with pancreatic cancer or colorectal cancer and chemo-naive patients with prostate cancer treated with adjuvant or first-line palliative chemotherapy comprising satisfaction with given information, recall of potential side effects, and handling of hypothetical side effect scenarios. We evaluated the association between baseline characteristics, ie, age, frailty (G8 score), comorbidity (Charlson Comorbidity Index), cognitive function (Mini-Cog), satisfaction, recall of information, and handling of side effects. RESULTS: Reduced ability to recall information about several side effects (eg, chest pain) was associated with older age (odds ratio adjusted for cancer [aOR] 0.94 [95% CI, 0.88-0.98]) and poor cognitive screening (aOR 0.56 [95% CI, 0.33-0.91]). Insufficient or dangerous handling of side effects was associated with older age (aOR 0.96 (95% CI, 0.92-0.99)) and cognitive impairment (aOR 0.70 [95% CI, 0.50-0.95]). CONCLUSION: Older age and poor cognitive screening may impact patients' ability to understand and adequately handle chemotherapy-related side effects. Cognitive screening and focus on individual ways to give information including assessment of recall and handling are needed.

"Doing What Only I Can Do": Experiences From Participating in a Multimodal Exercise-Based Intervention in Older Patients With Advanced Cancer-A Qualitative Explorative Study.

BACKGROUND: Sparse evidence exists regarding the feasibility and patients' experiences of exercise programs among older cancer populations. OBJECTIVE: The aim of this study was to explore the experiences of older patients with advanced cancer who participated in a 12-week supervised and multimodal exercise program in a hospital setting. METHODS: Individual interviews were conducted with 18 participants (≥65 years) with advanced cancer who completed the intervention program regardless of compliance rate. In addition, written evaluation questionnaires were collected. Data were analyzed using thematic analysis. RESULTS: Three main themes were identified: (1) Motivated to strengthen body and mind, with the subthemes "Doing what only I can do" and "Reaching goals with support from healthcare professionals and peers"; (2) Exercise as an integrated part of the treatment course; and (3) Overcoming undeniable physical limitations. CONCLUSIONS: The participants experienced several benefits from participation, including physical improvements, increased energy, reduction of symptoms, and improved social engagement. Goal setting, being positively pushed and cheered on, and integration of fun games increased motivation. In contrast, being pushed beyond physical limitations and experiencing severe symptoms were experienced as barriers toward exercising. Adherence to the exercise program was facilitated by coordinating a tailored program with medical appointments and receiving comprehensive support and guidance. IMPLICATIONS FOR PRACTICE: Multimodal exercise programs seem to be beneficial for older patients with advanced cancer and should be coordinated with oncological treatment in combination with targeted support and advice on symptom management.

Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT).

INTRODUCTION: Comprehensive geriatric assessment (CGA) has been shown to reduce frailty in older patients in general. In older patients with cancer, frailty affects quality of life (QoL), physical function, and survival. However, few studies have examined the effect of CGA as an additional intervention to antineoplastic treatment. This protocol presents a randomized controlled trial, which aims to evaluate the effects of CGA-based interventions in older patients with cancer and Geriatric 8 (G8) identified frailty. MATERIALS AND METHODS: This randomized controlled trial will include patients, age 70+ years, with solid malignancies and G8 frailty (G8 ≤ 14). Patients will be separated into two groups, with different primary endpoints, depending on palliative or curative antineoplastic treatment initiation, and subsequently randomized 1:1 to either CGA with corresponding interventions or standard of care, along with standardized antineoplastic treatment. A geriatrician led CGA with corresponding interventions and clinical follow-up will be conducted within one month of antineoplastic treatment initiation. The interdisciplinary CGA will cover multiple geriatric domains and employ a standard set of validated assessment tools. Primary endpoints will be physical decline measured with the 30-s Chair-Stand-Test at three months (palliative setting) and unplanned hospital admissions at six months (curative setting). Additional outcomes include QoL, treatment toxicity and adherence, occurrence of polypharmacy, potential drug interactions, potential inappropriate medications, and survival. The primary outcomes will be analyzed using a mixed model regression analysis (30-s chair stand test) and linear regression models (unplanned hospitalizations), with an intention to treat approach. Power calculations reveal the need to enroll 134 (palliative) and 188 (curative) patients. DISCUSSION: The present study will examine whether CGA, as an additional intervention to antineoplastic treatment, can improve endpoints valued by older patients with cancer. Inclusion began November 2020 and is ongoing, with 37 and 29 patients recruited April 15th, 2021. Registration:NCT04686851.

Effects of a 12-Week Multimodal Exercise Intervention Among Older Patients with Advanced Cancer: Results from a Randomized Controlled Trial.

BACKGROUND: Older patients with cancer are at risk of physical decline and impaired quality of life during oncological treatment. Exercise training has the potential to reduce these challenges. The study aim was to investigate the feasibility and effect of a multimodal exercise intervention in older patients with advanced cancer (stages III/IV). PATIENTS AND METHODS: Eighty-four older adults (≥65 years) with advanced pancreatic, biliary tract, or non-small cell lung cancer who received systemic oncological treatment were randomized 1:1 to an intervention group or a control group. The intervention was a 12-week multimodal exercise-based program including supervised exercise twice weekly followed by a protein supplement, a home-based walking program, and nurse-led support and counseling. The primary endpoint was change in physical function (30-second chair stand test) at 13 weeks. RESULTS: Median age of the participants was 72 years (interquartile range [IQR] 68-75). Median adherence to the exercise sessions was 69% (IQR 21-88) and 75% (IQR 33-100) for the walking program. At 13 weeks, there was a significant difference in change scores of 2.4 repetitions in the chair stand test, favoring the intervention group (p < .0001). Furthermore, significant beneficial effects were seen for physical endurance (6-minute walk test), hand grip strength, physical activity, symptom burden, symptoms of depression and anxiety, global health status (quality of life), and lean body mass. No effects were seen for dose intensity, hospitalizations, or survival. CONCLUSION: A 12-week multimodal exercise intervention with targeted support proved effective in improving physical function in older patients with advanced cancer during oncological treatment.

Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients with Solid Cancers: Protocol for a Danish prospective cohort study (PROGNOSIS-G8).

INTRODUCTION: Older patients with cancer constitute a heterogeneous group with varying degrees of frailty; therefore, geriatric assessment with initial geriatric oncology screening is recommended. The Geriatric 8 (G8) and the modified Geriatric 8 (mG8) are promising screening tools with high accuracy and an association with survival. However, evidence is sparse regarding patient-centered outcomes. This protocol describes a study, which aims to address the predictive and prognostic value of the G8 and mG8, with quality of life (QoL) as the primary outcome. MATERIALS AND METHODS: In this single-center prospective cohort study, patients, age ≥70 years with solid malignancies, will be screened with the G8 and mG8 prior to receiving 1st line antineoplastic treatment. Patients will contribute medical record data including; cancer type, Charlson comorbidity index score, performance status, and treatment intent, type, and dosage, at baseline. Patients will complete QoL questionnaires (EORTC QLQ-C30 and ELD-14) at baseline, 3, 6, 9, and 12-months follow-up. Two functional measurements (the 30-s chair stand test and the handgrip strength test) will be conducted at baseline to assess the added predictive and prognostic value. At 12 months follow-up, initially administered treatment and treatment adherence will be recorded and assessed with generalized linear models, while overall survival and cancer-specific survival will be assessed using survival analysis models with time-varying covariates. The relationship between frailty (G8 ≤ 14, mG8 ≥ 6) and QoL within 12 months will be examined using mixed regression models. DISCUSSION: Geriatric oncology screening may identify a subgroup of older patients with frailty, at risk of experiencing diminishing QoL and poor treatment adherence. With the proposed screening program, patients who require treatment modification and additional support to maintain their QoL may be identified. It is our hope, that these insights may facilitate the formation of national guidelines for the treatment of older patients with cancer. Registration:NCT04644874.

The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO).

BACKGROUND: Older patients with colorectal cancer (CRC) experience chemotherapy dose reductions or discontinuation. Comprehensive geriatric assessment (CGA) predicts survival and chemotherapy completion in patients with cancer, but the benefit of geriatric interventions remains unexplored. METHODS: The GERICO study is a randomised Phase 3 trial including patients ≥70 years receiving adjuvant or first-line palliative chemotherapy for CRC. Vulnerable patients (G8 questionnaire ≤14 points) were randomised 1:1 to CGA-based interventions or standard care, along with guideline-based chemotherapy. The primary outcome was chemotherapy completion without dose reductions or delays. Secondary outcomes were toxicity, survival and quality of life (QoL). RESULTS: Of 142 patients, 58% received adjuvant and 42% received first-line palliative chemotherapy. Interventions included medication changes (62%), nutritional therapy (51%) and physiotherapy (39%). More interventional patients completed scheduled chemotherapy compared with controls (45% vs. 28%, P = 0.0366). Severe toxicity occurred in 39% of controls and 28% of interventional patients (P = 0.156). QoL improved in interventional patients compared with controls with the decreased burden of illness (P = 0.048) and improved mobility (P = 0.008). CONCLUSION: Geriatric interventions compared with standard care increased the number of older, vulnerable patients with CRC completing adjuvant chemotherapy, and may improve the burden of illness and mobility. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02748811.

Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial).

BACKGROUND: The incidence of colorectal cancer (CRC) increases with age. Older patients are a heterogeneous group ranging from fit to frail with various comorbidities. Frail older patients with CRC are at increased risk of negative outcomes and functional decline after cancer surgery compared to younger and fit older patients. Maintenance of independence after treatment is rarely investigated in clinical trials despite older patients value it as high as survival. Comprehensive geriatric assessment (CGA) is an evaluation of an older persons' medical, psychosocial, and functional capabilities to develop an overall plan for treatment and follow-up. The beneficial effect of CGA is well documented in the fields of medicine and orthopaedic surgery, but evidence is lacking in cancer surgery. We aim to investigate the effect of CGA on physical performance in older frail patients undergoing surgery for CRC. METHODS: GEPOC is a single centre randomised controlled trial including older patients (≥65 years) undergoing surgical resection for primary CRC. Frail patients (≤14/17 points using the G8 screening tool) will be randomised 1:1 to geriatric intervention and exercise (n = 50) or standard of care along (n = 50) with their standard surgical procedure. Intervention includes preoperative CGA, perioperative geriatric in-ward review and postoperative follow-up. All patients in the intervention group will participate in a pre- and postoperative resistance exercise programme (twice/week, 2 + 12 weeks). Primary endpoint is change in 30-s chair stand test. Assessment of primary endpoint will be performed by physiotherapists blinded to patient allocation. Secondary endpoints: changes in health related quality of life, physical strength and capacity (handgrip strength, gait speed and 6 min walking test), patient perceived quality of recovery, complications to surgery, body composition (Dual-energy X-ray absorptiometry and bioelectric impedance), serum biomarkers, readmission, length of stay and survival. DISCUSSION: This ongoing trial will provide valuable knowledge on whether preoperative CGA and postoperative geriatric follow-up and intervention including an exercise program can counteract physical decline and improve quality of life in frail CRC patients undergoing surgery. TRIAL REGISTRATION: Prospectively registered at Clinicaltrials.gov NCT03719573 (October 2018).

Clinical presentation and mortality in hospitalized patients aged 80+ years with COVID-19-A retrospective cohort study.

BACKGROUND: COVID-19, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has great health implications in older patients, including high mortality. In general, older patients often have atypical symptom presentations during acute illness due to a high level of comorbidity. The purpose of this study was to investigate the presentation of symptoms at hospital admissions in older patients with COVID-19 and evaluate its impact on disease outcome. METHODS: This retrospective study included patients ≥80 years of age with a positive test for SARS-CoV-2, who were admitted to one of three medical departments in Denmark from March 1st to June 1st, 2020. RESULTS: A total of 102 patients (47% male) with a mean age of 85 years were included. The most common symptoms at admission were fever (74%), cough (62%), and shortness of breath (54%). Furthermore, atypical symptoms like confusion (29%), difficulty walking (13%), and falls (8%) were also present. In-hospital and 30-day mortality were 31% (n = 32) and 41% (n = 42), respectively. Mortality was highest in patients with confusion (50% vs 38%) or falls (63% vs 39%), and nursing home residency prior to hospital admission was associated with higher mortality (OR 2.7, 95% CI 1.1-6.7). CONCLUSIONS: Older patients with SARS-Cov-2 displayed classical symptoms of COVID-19 but also geriatric frailty symptoms such as confusion and walking impairments. Additionally, both in-hospital and 30-day mortality was very high. Our study highlights the need for preventive efforts to keep older people from getting COVID-19 and increased awareness of frailty among those with COVID-19.