Efficacy and Feasibility of Presurgical Exercise in Bladder Cancer Patients Scheduled for Open Radical Cystectomy.

PURPOSE: This study aimed to examine the feasibility and potential efficacy of presurgical exercise in patients with bladder cancer scheduled for open radical cystectomy with follow-up postsurgery. METHODS: Prospective single-group design with assessments at baseline, presurgery, and 3 months postsurgery was used in this study. Multimodal supervised resistance and aerobic exercise was undertaken 2-3 d·wk -1 at moderate intensity for a median of 3.5 wk (interquartile range [IQR] = 1.3-5.6). Feasibility was assessed by recruitment and completion rates, patient safety, program tolerance, adherence, and compliance. Lean and fat mass were assessed by dual-energy x-ray absorptiometry, physical function by a battery of tests (chest press and leg press strength, 6-min walk test [6MWT], timed up-and-go, repeated chair rise), and quality of life (QoL), psychological distress, and body image by questionnaire. Hospital length of stay (LOS) and complications were assessed by medical records. RESULTS: Thirty-seven patients were referred with 20 recruited (67.3 ± 12.2 yr) and a presurgery intervention completion rate of 80% (16 of 20). The individual median program adherence was 100.0% (IQR = 89.4-100.0) with compliance of 100.0% (IQR = 90.5-100.0) for resistance exercise and 81.8% (IQR = 55.0-99.5) for aerobic exercise. There were no exercise-related adverse events. Body composition did not change presurgery; however, there were improvements ( P < 0.05) in leg press strength (16%), 6MWT distance (8%), timed up-and-go (12%), chair rise (10%), and multiple QoL domains including mental health. Median LOS was 8.0 d (IQR = 7.0, 15.0). Postsurgery, there were declines in components of QoL and apparent body image dissatisfaction. CONCLUSIONS: A preradical cystectomy exercise program is feasible, safe, and well tolerated with improvements in physical function and QoL. Supervised multimodal exercise in bladder cancer patients before cystectomy can enhance physical and mental health potentially buffering the effects of surgery.

Reporting Attendance and Resistance Exercise Compliance in Men with Localized Prostate Cancer.

PURPOSE: Resistance exercise is a well-established intervention to counteract musculoskeletal and metabolic toxicities from prostate cancer treatment. In this study, we reported resistance exercise attendance and compliance, and examined if these variables can influence changes in outcomes of interest in men with localized or locally advanced prostate cancer. METHODS: A total of 83 prostate cancer patients (age, 68.2 ± 7.0 yr; body mass index, 27.7 ± 3.8 kg·m -2 ) who had undergone 6 months of resistance-based exercise and had data available on exercise training from logbook records were examined. Attendance outcomes such as missed sessions, interruptions and permanent discontinuation, and metrics such as dosage completed (sessions × number of exercises × sets × repetitions × external load), compliance, tolerance, reductions, and escalations were assessed. Outcomes assessed were body composition, physical function, and muscle strength. RESULTS: Median resistance exercise attendance was 80.6%, with a median resistance exercise compliance of 88.5% (interquartile range [IQR], 61.1%-107.1%) per participant. A median of 11 (IQR, 1-26) and 0 (IQR, 0-2) sessions were escalated or reduced, respectively. Significant improvements were observed in whole-body lean mass, 400-m walk, repeated chair rise, leg press, and chest press strength after 6 months of intervention ( P < 0.05) regardless of resistance exercise compliance ( Ptrend = 0.199-0.950). Participants with higher levels of resistance exercise compliance presented greater improvements in trunk fat mass ( Ptrend = 0.026) and appendicular lean mass ( Ptrend = 0.047). CONCLUSIONS: A higher resistance exercise compliance led to greater improvements in regional fat and lean mass, whereas physical function and muscle strength improvements were achieved with lower compliance. In addition, patients experienced a high number of dose escalations during the intervention. These findings are important to improve the reproducibility/precision of exercise medicine prescription.

Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment.

INTRODUCTION: Evidence regarding the role of exercise in pancreatic cancer (PanCa) is limited and is derived exclusively under tightly controlled research conditions. This study aimed to quantify adherence, adverse events, and changes in physical and psychological outcomes in any patients with PanCa referred to undertake exercise during nonsurgical treatment. METHODS: The study involved 22 patients with localized or metastatic PanCa undertaking a clinic-based exercise program during chemotherapy or chemoradiotherapy. The program included supervised aerobic and resistance exercise undertaken twice weekly for 12 wk and a 12-wk follow-up with supervised exercise optional dependent on patient preference and condition. Patients were monitored for adherence and adverse events. Objective and patient-reported outcomes were assessed at baseline, 12 wk, and 24 wk. RESULTS: A total of 251 sessions were attended by 19 patients over the first 12 wk (attendance rate, 55%). Complete case analyses indicated significant ( P < 0.05) improvements in functional ability (5.2%-17.2%), muscle strength (16.9%-25.1%), and static balance (6.8%). There were no significant changes in body composition or patient-reported outcomes except for sleep quality, which deteriorated; however, at an individual level, several patients had clinically relevant improvements in cancer-related fatigue and quality of life. Patients who continued with supervised exercise to week 24 largely preserved improvements in functional ability, muscle strength, and static balance. No serious adverse events resulted from the exercise program. CONCLUSIONS: Individualized, supervised aerobic and resistance exercise in a clinic-based setting appears to be safe and may improve or maintain physical and psychological health in patients with PanCa undergoing nonsurgical treatment.

Building the plane while it's flying: implementation lessons from integrating a co-located exercise clinic into oncology care.

BACKGROUND: Despite its therapeutic role during cancer treatment, exercise is not routinely integrated into care and implementation efforts are largely absent from the literature. The aim of this study was to evaluate a strategy to integrate the workflow of a co-located exercise clinic into routine care within a private oncology setting in two clinics in the metropolitan region of Western Australia. METHODS: This prospective evaluation utilised a mixed methods approach to summarise lessons learned during the implementation of an integrated exercise workflow and supporting implementation plan. Data collection was informed by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Reports detailing utilisation of the exercise service and its referral pathways, as well as patient surveys and meeting minutes documenting the implementation process informed the evaluation. RESULTS: The co-located exercise service achieved integration into routine care within the clinical oncology setting. Patient utilisation was near capacity (reach) and 100% of clinicians referred to the service during the 13-month evaluation period (adoption). Moreover, ongoing adaptations were made to improve the program (implementation) and workflows were integrated into standard operating practices at the clinic (maintenance). The workflow performed as intended for ~70% of exercise participants (effectiveness); however, gaps were identified in utilisation of the workflow by both patients and clinicians. CONCLUSION: Integration of exercise into standard oncology care is possible, but it requires the ongoing commitment of multiple stakeholders across an organisation. The integrated workflow and supporting implementation plan greatly improved utilisation of the co-located exercise service, demonstrating the importance of targeted implementation planning. However, challenges regarding workflow fidelity within and across sites limited its success highlighting the complexities inherent in integrating exercise into clinical oncology care in a real-world setting.

Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial).

INTRODUCTION: Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer. METHODS AND ANALYSIS: A single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7-12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Edith Cowan University Human Research Ethics Committee (ID: 2021-02157-GALVAO). Outcomes from the study will be published in academic journals and presented in scientific and consumer meetings. TRIAL REGISTRATION NUMBER: ACTRN12621001312831.

Nationwide Industry-Led Community Exercise Program for Men With Locally Advanced, Relapsed, or Metastatic Prostate Cancer on Androgen-Deprivation Therapy.

PURPOSE: Androgen-deprivation therapy in patients with prostate cancer (PCa) is associated with considerable side effects and secondary comorbidities such as overweight/obesity and cardiovascular disease. The aim of this study was to investigate the effectiveness of an industry-led, treatment-integrated, community-based exercise program on outcomes of body weight, cardiovascular health, and physical function. PATIENTS AND METHODS: PCa patients with locally advanced, relapsed, or metastatic disease receiving leuprorelin acetate were enrolled across multiple sites in Australia and assigned supervised group exercise undertaken weekly or biweekly (ie, 16 exercise sessions in total) for 10-18 weeks, consisting of aerobic and resistance training performed at moderate-to-vigorous intensity. RESULTS: Between 2014 and 2020, 760 participants completed the baseline and follow-up assessment. Participants were age 48-94 years, and most were either overweight (42.1%) or obese (38.1%). Program compliance was high, with 90% of participants completing all 16 exercise sessions. There was a small but significant reduction in waist circumference (-0.9 cm; 95% CI [-1.2 to -0.5]; P < .001) and no change in weight or body mass index. Systolic (-3.7 mmHg; 95% CI [-4.8 to -2.6]; P < .001) and diastolic (-1.7 mmHg; 95% CI [-2.3 to -1.0]; P < .001) blood pressure were significantly lower after the program. Furthermore, significant improvements were seen in cardiorespiratory fitness and muscle strength (P < .001). For most of the investigated outcomes, participants with poorer initial measures had the greatest benefit from participating in the program. CONCLUSION: The community exercise program was feasible and effective in preventing weight gain, reducing blood pressure, and improving physical function in patients with PCa on androgen-deprivation therapy.

Exercise medicine for cancer cachexia: targeted exercise to counteract mechanisms and treatment side effects.

PURPOSE: Cancer-induced muscle wasting (i.e., cancer cachexia, CC) is a common and devastating syndrome that results in the death of more than 1 in 5 patients. Although primarily a result of elevated inflammation, there are multiple mechanisms that complement and amplify one another. Research on the use of exercise to manage CC is still limited, while exercise for CC management has been recently discouraged. Moreover, there is a lack of understanding that exercise is not a single medicine, but mode, type, dosage, and timing (exercise prescription) have distinct health outcomes. The purpose of this review was to examine the effects of these modes and subtypes to identify the most optimal form and dosage of exercise therapy specific to each underlying mechanism of CC. METHODS: The relevant literatures from MEDLINE and Scopus databases were examined. RESULTS: Exercise can counteract the most prominent mechanisms and signs of CC including muscle wasting, increased protein turnover, systemic inflammation, reduced appetite and anorexia, increased energy expenditure and fat wasting, insulin resistance, metabolic dysregulation, gut dysbiosis, hypogonadism, impaired oxidative capacity, mitochondrial dysfunction, and cancer treatments side-effects. There are different modes of exercise, and each mode has different sub-types that induce vastly diverse changes when performed over multiple sessions. Choosing suboptimal exercise modes, types, or dosages can be counterproductive and could further contribute to the mechanisms of CC without impacting muscle growth. CONCLUSION: Available evidence shows that patients with CC can safely undertake higher-intensity resistance exercise programs, and benefit from increases in body mass and muscle mass.

Exercise intervention and sexual function in advanced prostate cancer: a randomised controlled trial.

OBJECTIVES: Treatments for prostate cancer such as androgen deprivation therapy (ADT), surgery and radiation therapy can adversely affect sexual, urinary and bowel function. Preliminary research has demonstrated the efficacy of exercise to preserve sexual function in men with localised prostate cancer receiving ADT, though this has yet to be investigated in a metastatic setting. We examined the effects of a 12-week exercise programme comprising resistance, aerobic and flexibility training on sexual health and function in men with advanced prostate cancer. METHODS: Patients with prostate cancer (70.0±8.4 year; body mass index 28.7±4.0 kg/m2) with bone metastases (rib/thoracic spine, 66.7%; lumbar spine, 43.9%; pelvis, 75.4%; femur, 40.4%; humerus, 24.6%; other sites, 70.2%) were randomly assigned to supervised exercise 3 days/week (n=28) or usual care (n=29). Sexual health and function were assessed using the International Index of Erectile Function, the Expanded Prostate Cancer Index Composite and the EORTC-PR25 at baseline and 12 weeks. RESULTS: Patients attended 89% of planned sessions and there were no adverse events. After adjusting for baseline values, there was no significant difference between groups for any measure of sexual function and activity (p>0.05). Additionally, there was no significant difference between groups for urinary and bowel function assessed by the EORTC-PR25 (p>0.05). CONCLUSIONS: A short-term programme of supervised exercise does not appear to enhance indices of sexual health and function in men with advanced prostate cancer. Limitations of the intervention included the conservative modular exercise programme, which deliberately avoided loading bone metastatic sites. TRIAL REGISTRATION NUMBER: ACTRN12611001158954.

Associations of fat and muscle mass with overall survival in men with prostate cancer: a systematic review with meta-analysis.

BACKGROUND: To systematically review and analyse the associations between fat and muscle mass measures with overall survival in men with prostate cancer. METHODS: A systematic search was conducted in CINAHL, Cochrane Library, EMBASE, PubMed, and Web of Science databases from inception to December 2020, while abstracts from the American Society of Clinical Oncology (ASCO), Clinical Oncology Society of Australia (COSA), and the American College of Sports Medicine (ACSM) conferences were searched from 2014 to 2020. Eligible articles examined the association of body composition measures, such as fat mass (e.g., fat mass, visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and VAT/SAT) and muscle mass measures, with overall survival in prostate cancer patients at any treatment stage. The primary endpoint was overall survival. Random-effect meta-analysis was conducted for studies reporting multivariable or univariable analysis assessing the associations of fat mass measures (i.e., fat mass, VAT, SAT, VAT/SAT) and muscle mass measures with overall survival. RESULTS: Sixteen cohort studies that comprised 4807 men with prostate cancer were included. Total adiposity (hazard ratio (HR) 0.98, 95% CI: 0.75-1.28, p = 0.888) and VAT (HR 1.03, 95% CI: 0.74-1.43, p = 0.873) were not significantly associated with overall survival, while higher subcutaneous adipose tissue levels were associated with higher survival (HR 0.68, 95% CI: 0.54-0.84, p = 0.001). Greater mortality risk was found in patients with localised (HR 1.91, 95% CI: 1.40-2.62, p < 0.001) and advanced disease (HR 1.43, 95% CI: 1.07-1.92, p = 0.020) presenting with low levels of muscle mass compared to those presenting with high levels. DISCUSSION: These results indicate that although overall adiposity should be cautiously interpreted in regards to survival, high muscle mass and SAT, and low VAT/SAT ratio values are associated with overall survival in men with prostate cancer.

Implementation barriers to integrating exercise as medicine in oncology: an ecological scoping review.

PURPOSE: While calls have been made for exercise to become standard practice in oncology, barriers to implementation in real-world settings are not well described. This systematic scoping review aimed to comprehensively describe barriers impeding integration of exercise into routine oncology care within healthcare systems. METHODS: A systematic literature search was conducted across six electronic databases (since 2010) to identify barriers to implementing exercise into real-world settings. An ecological framework was used to classify barriers according to their respective level within the healthcare system. RESULTS: A total of 1,376 results were retrieved; 50 articles describing implementation barriers in real-world exercise oncology settings were reviewed. Two hundred and forty-three barriers were identified across all levels of the healthcare system. Nearly 40% of barriers existed at the organizational level (n = 93). Lack of structures to support exercise integration and absence of staff/resources to facilitate its delivery were the most common issues reported. Despite the frequency of barriers at the organizational level, organizational stakeholders were largely absent from the research. CONCLUSIONS: Implementing exercise into routine cancer care is hindered by a web of interrelated barriers across all levels of the healthcare system. Organizational barriers are central to most issues. Future work should take an interdisciplinary approach to explore best practices for overcoming implementation barriers, with organizations as a central focus. IMPLICATIONS FOR CANCER SURVIVORS: This blueprint of implementation barriers highlights critical issues that need to be overcome to ensure people with cancer have access to the therapeutic benefits of exercise during treatment and beyond.

Effects of Exercise During Radiation Therapy on Physical Function and Treatment-Related Side Effects in Men With Prostate Cancer: A Systematic Review and Meta-Analysis.

PURPOSE: Radiation therapy is a commonly used treatment for prostate cancer; however, the side effects may negatively affect quality of life and cause patients to be less physically active. Although exercise has been shown to mitigate radiation therapy-related fatigue in men with prostate cancer during radiation therapy, other adverse effects of treatment such as physical deconditioning, urinary symptoms, or sexual dysfunction have not been systematically reviewed in this patient population. Thus, the purpose of this review was to investigate the effect of exercise on physical function and treatment-related side effects in men with prostate cancer undergoing radiation therapy. METHODS: A systematic literature search was conducted in the PubMed, Embase, CINAHL Plus, SPORTDiscus, and Web of Science databases in December 2020. Included studies were randomized controlled trials examining the effects of aerobic and/or resistance exercise interventions on measures of physical function and treatment-related side effects in prostate cancer patients undergoing radiation therapy. Meta-analysis was performed on outcomes that were reported in 2 or more studies. RESULTS: Seven publications from 6 randomized controlled trials involving 391 prostate cancer patients were included. Patients had stage I to IV cancer with a Gleason score of ≤6 to 10. Exercise resulted in consistent significant benefits for physical function in terms of cardiovascular fitness (standardized mean difference [SMD], 0.83; 95% confidence interval [CI], 0.31-1.36; P < .01) and muscle function (SMD, 1.30; 95% CI, 0.53-2.07; P < .01). Furthermore, there was a significant positive effect of exercise on urinary toxicity (SMD, -0.71; 95% CI, -1.25 to -0.18; P < .01), but not on intestinal (P = .21) or hormonal toxicity (P = .41), depression (P = .45), or sleep symptoms (P = .88). CONCLUSION: Based on the current evidence, exercise in men with prostate cancer undergoing radiation therapy improves physical function and mitigates urinary toxicity. The effect of exercise on other treatment-related side effects are less clear and require further investigation.

Feasibility and efficacy of a multicomponent exercise medicine programme in patients with pancreatic cancer undergoing neoadjuvant therapy (the EXPAN trial): study protocol of a dual-centre, two-armed phase I randomised controlled trial.

INTRODUCTION: Exercise is emerging as a therapy in oncology for its physical and psychosocial benefits and potential effects on chemotherapy tolerability and efficacy. However, evidence from randomised controlled trials (RCTs) supporting exercise in patients with borderline resectable or locally advanced pancreatic cancer (PanCa) undergoing neoadjuvant therapy (NAT) are lacking. METHODS AND ANALYSIS: The EXPAN trial is a dual-centre, two-armed, phase I RCT. Forty patients with borderline resectable or locally advanced PanCa undergoing NAT will be randomised equally to an exercise intervention group (individualised exercise+standard NAT) or a usual care control group (standard NAT). The exercise intervention will be supervised and consist of moderate to vigorous intensity resistance and aerobic-based training undertaken two times a week for 45-60 min per session for a maximum period of 6 months. The primary outcome is feasibility. Secondary outcomes are patient-related and treatment-related endpoints, objectively measured physical function, body composition, psychological health and quality of life. Assessments will be conducted at baseline, prior to potential alteration of treatment (~4 months postbaseline), at completion of the intervention (maximum 6 months postbaseline) and 3-month and 6-month postintervention (maximum 9 and 12 months postbaseline). ETHICS AND DISSEMINATION: The EXPAN trial has been approved by Edith Cowan University (reference no.: 2020-02011-LUO), Sir Charles Gairdner Hospital (reference no.: RGS 03956) and St John of God Subiaco Hospital (reference no.: 1726). The study results will be presented at national/international conferences and submitted for publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12620001081909.

Radiotherapy before or during androgen-deprivation therapy does not blunt the exercise-induced body composition protective effects in prostate cancer patients: A secondary analysis of two randomized controlled trials.

BACKGROUND: Androgen deprivation therapy (ADT) contributes to lean mass loss and adiposity increases in prostate cancer patients. Radiotherapy during ADT might act synergistically and further worsen body composition. Previous investigations have shown that resistance training is an effective method of preserving body composition during ADT, however, most have not accounted for direct or indirect effects of other therapies, such as radiotherapy. Therefore, the purpose of this study was to examine training adaptations of the tissue composition in patients receiving radiation therapy (RT) prior or during ADT. METHODS: Analyses were performed by combining data from two previous trials for a total of 131 prostate cancer patients who underwent a combination of resistance and aerobic exercise training (N = 70, age: 68.9 ± 6.6y, RT-before: 13%, RT-during: 14%) or usual care (N = 61, age: 67.5 ± 7.9y, RT-before: 16%, RT-during: 20%) for 3 months upon ADT onset. Whole-body lean mass (LM), fat percentage and appendicular LM were determined by dual energy x-ray absorptiometry, and lower-leg muscle area and density by peripheral computed tomography at baseline (onset of ADT) and at 3 months post-intervention. Covariates included RT prior and during the intervention, demographic characteristics, physical symptoms, and chronic conditions. RESULTS: Radiotherapy before or during the intervention did not affect body composition. Only the usual care group experienced a significant decrease in whole-body LM (-994 ± 150 g, P < 0.001) and appendicular LM (-126 ± 19 g, P < 0.001), and an increase in whole-body fat percentage (1% ± 0.1%, P < 0.001). There was no change in lower-leg muscle area or density in either group. CONCLUSION: We suggest that radiation prior to and during ADT does not interfere with the beneficial effects of exercise training on body composition in men with prostate cancer.

Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review.

ABSTRACT: The aim of this study was to examine the health-related effects of exercise in patients with pancreatic cancer (PanCa) through a systematic review of current evidence. Studies were obtained through searching PubMed, Web of Science, PsycINFO, Embase, CINAHL Plus, and Cochrane Library databases with additional hand searches. All intervention-based studies were included if it involved (1) adult patients with PanCa, (2) exercise training, and (3) findings in quality of life, cancer-related fatigue, psychological distress, and physical function. The review protocol was registered in PROSPERO: CRD42020154684. Seven trials described in 9 publications were included consisting of 201 patients with early-stage and advanced PanCa. Participants were required to perform supervised and/or home-based, low- to moderate-intensity resistance and/or aerobic exercise for 12 to 35 weeks or duration of neoadjuvant therapy. There were no exercise-related adverse events with a reported retention rate of 71% to 90% and exercise attendance of 64% to 96%. The programs were consistently associated with improvements in cancer-related fatigue, psychological distress, and physical function, with mixed effects on quality of life. Exercise training seems to be safe and feasible and may have a beneficial effect on various physical and psychological outcomes in patients with PanCa. Further work with rigorous study designs is required to consolidate and advance current findings.

Effect of Exercise Adjunct to Radiation and Androgen Deprivation Therapy on Patient-Reported Treatment Toxicity in Men With Prostate Cancer: A Secondary Analysis of 2 Randomized Controlled Trials.

PURPOSE: Physical inactivity, in addition to clinical factors, has been associated with higher levels of late pelvic symptoms in patients with prostate cancer (PCa) after radiation therapy. The aim of this study was to investigate the effect of a structured multicomponent exercise program comprised of aerobic and resistance training as well as impact loading on the prevalence and severity of symptoms commonly resulting from androgen deprivation therapy (ADT) and pelvic radiation therapy. METHODS AND MATERIALS: We performed a secondary analysis of pooled data from 2 randomized controlled trials that investigated the role of exercise on treatment-related side effects in patients with PCa receiving ADT. Patients were included in the analysis if they had undergone radiation therapy during the intervention in addition to ADT. Patient-reported quality of life and functional and symptom scales were assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and PR25 before and after 6 months of exercise or usual care (UC). RESULTS: One-hundred and fifteen patients with PCa receiving ADT, aged 47 to 84 years, who also underwent radiation therapy were included in the analysis (exercise, n = 72; UC, n = 43). There was a significant reduction in physical functioning (P = .019) and increased fatigue (P = .007) in the control group, with no change observed in the exercise group. Similarly, there was a trend toward reduced sexual activity in the control group (P = .064), with a mean adjusted change of -7.1 points. Furthermore, the prevalence of clinically important pain at 6 months was lower in the exercise group compared with UC (18.1 vs 37.2%, P = .022). No between-group differences were found for urinary (P = .473) or hormonal treatment-related symptoms (P = .552). CONCLUSIONS: Exercise during concomitant hormone and radiation treatment for men with PCa may mitigate some adverse changes in patient-reported fatigue, physical functioning, and possibly sexual activity. The promotion and provision of exercise to counter a range of treatment-related adverse effects in patients with PCa undergoing radiation therapy and ADT should be actively encouraged.

Investigation of Relation of Radiation Therapy Quality With Toxicity and Survival in LAP07 Phase 3 Trial for Locally Advanced Pancreatic Carcinoma.

PURPOSE: The LAP07 multicenter randomized study assessed whether chemoradiation therapy increases overall survival versus continuation chemotherapy in patients whose locally advanced pancreatic cancer was controlled after 4 months of induction chemotherapy. This analysis investigated whether failure to adhere to radiation therapy (RT) guidelines influenced survival and toxicity. METHODS AND MATERIALS: This is a planned analysis of secondary objectives in the framework of a randomized international phase 3 trial. The protocol included detailed written RT guidelines. All participating institutions undertook an initial benchmark case to check adherence to protocol guidelines. Centers with major deviation were not allowed to include patients until they achieved a significant improvement and rigorously followed the guidelines. On-trial RT quality assurance consisted of a central review of treatment plan with dose-volume histograms for each patient. Adherence to guidelines was graded as per protocol (PP), minor deviation (MiD), or major deviation (MaD). RESULTS: Fifty-seven benchmark cases were evaluated, 26% were classified as PP, 60% were MiD, and 14% were MaD. Among the 442 included patients, 133 patients were randomized in the chemoradiation therapy arm, and 117 patients were assessable for RT quality analysis. RT quality was graded as PP in 38.5% of patients, MiD in 43.6% of patients, and MaD in 17.9% of patients. The most frequent protocol violations were dose distribution heterogeneities. Median overall survival was 17 months with PP and MiD versus 13.4 months with MaD (hazard ratio [HR], 1.63; 95% confidence interval [CI], 0.99-2.71; P = .055). There was no difference in terms of progression-free survival (HR, 1.09; 95% CI, 0.66-1.8; P = .72). Patients with MaD had more nausea than patients treated PP or with MiD (P = .0045). CONCLUSIONS: MaD was associated with a trend for worst survival. There was no difference in terms of progression-free survival. Because of the low rate of major deviations, their effects on the LAP07 trial results may be negligeable.

Psychological distress in men with prostate cancer undertaking androgen deprivation therapy: modifying effects of exercise from a year-long randomized controlled trial.

OBJECTIVES: To assess the long-term effects of various exercise modes on psychological distress in men with prostate cancer on androgen deprivation therapy (ADT). PATIENTS AND METHODS: 135 prostate cancer patients aged 43-90 years on ADT were randomized to twice weekly supervised impact loading and resistance exercise (ImpRes), supervised aerobic and resistance exercise (AerRes), and usual care/delayed supervised aerobic exercise (DelAer) for 12 months, and completed measures of psychological distress using the Brief Symptom Inventory-18 (BSI-18). BSI-18 provides three subscales for anxiety, depression, and somatisation, as well as the global severity index (GSI) where higher scores indicate higher distress. RESULTS: Following the intervention, somatization was not different to baseline, however, there were significant interactions (p < 0.01) for depression, anxiety, and the GSI. In ImpRes, depression was reduced at 12 months compared to baseline and 6 months (0.78 ± 1.39 vs. 1.88 ± 3.24 and 1.48 ± 2.65, p < 0.001), as was the GSI (3.67 ± 4.34 vs. 5.94 ± 7.46 and 4.64 ± 4.73, p < 0.001) with anxiety reduced compared to baseline (1.08 ± 1.54 vs. 1.98 ± 2.56). Depression and the GSI decreased (p < 0.05) in AerRes at 6 months but increased by 12 months, while in DelAer the GSI was reduced at 12 months compared to 6 months (3.78 ± 3.94 vs. 5.25 ± 4.22, p = 0.031). Men with the highest level of anxiety, depression, somatization, and the GSI improved the most with exercise (ptrend < 0.001). CONCLUSION: Various supervised exercise modes (aerobic, resistance and impact loading) are effective in reducing psychological distress in men with prostate cancer on ADT. Those with the highest level of psychological distress improved the most. Supervised exercise should be prescribed to improve psychological health in prostate cancer patients on ADT.