Scheduled and Breakthrough Opioid Use for Cancer Pain in an Inpatient Setting at a Tertiary Cancer Hospital.

Background: Our aim was to examine the frequency and prescription pattern of breakthrough (BTO) and scheduled (SCH) opioids and their ratio (BTO/SCH ratio) of use, prior to and after referral to an inpatient supportive care consult (SCC) for cancer pain management (CPM). Methods and Materials: Patients admitted at the MD Anderson Cancer Center and referred to a SCC were retrospectively reviewed. Cancer patients receiving SCH and BTO opioids for ≥24 h were eligible for inclusion. Patient demographics and clinical characteristics, including the type and route of SCH and BTO opioids, daily opioid doses (MEDDs) of SCH and BTO, and BTO/SCH ratios were reviewed in patients seen prior to a SCC (pre-SCC) and during a SCC. A normal BTO ratio was defined as 0.5-0.2. Results: A total of 665/728 (91%) patients were evaluable. Median pain scores (p < 0.001), BTO MEDDs (p < 0.001), scheduled opioid MEDDs (p < 0.0001), and total MEDDs (p < 0.0001) were higher, but the median number of BTO doses was fewer (2 vs. 4, p < 0.001), among patients seen at SCC compared to pre-SCC. A BTO/SCH ratio over the recommended ratio (>0.2) was seen in 37.5% of patients. The BTO/SCH ratios in the pre-SCC and SCC groups were 0.10 (0.04, 0.21) and 0.17 (0.10, 0.30), respectively, p < 0.001. Hydromorphone and Morphine were the most common BTO and SCH opioids prescribed, respectively. Patients in the early supportive care group had higher pain scores and MEDDs. Conclusions: BTO/SCH ratios are frequently prescribed higher than the recommended dose. Daily pain scores, BTO MEDDs, scheduled opioid MEDDs, and total MEDDs were higher among the SCC group than the pre-SCC group, but the number of BTO doses/day was lower.

The role of corticosteroids in the palliation of dyspnea in cancer patients: an evidence-based review.

PURPOSE OF REVIEW: To provide an evidence-based review on the use of corticosteroids for dyspnea in cancer patients. RECENT FINDINGS: Corticosteroids are commonly used for palliation of dyspnea; however, there is wide variation in how they are prescribed due to the paucity of high-quality evidence. Some clinicians would offer corticosteroids routinely regardless of the causes of dyspnea, while others would only prescribe corticosteroids selectively for specific indications, such as lymphangitic carcinomatosis, upper airway obstruction, superior vena cava obstruction, and cancer treatment-induced pneumonitis. Few mechanistic studies have been conducted to support the use of corticosteroids in cancer patients. Two double-blind, placebo-controlled randomized trials have examined the routine use of high-dose dexamethasone for dyspnea in cancer patients. A pilot study suggested some benefits, but the larger confirmatory trial revealed no improvement compared to the placebo and significantly more adverse events. The selective use of corticosteroids use is only based on observational studies such as case series. SUMMARY: The unfavorable risk:benefit ratio of high-dose dexamethasone suggests that it should not be routinely prescribed for dyspnea in cancer patients. More research is needed to assess the selective use of corticosteroids and identify patients most likely be benefit from corticosteroid use.

Management of cancer pain in pregnancy: can opioids be used?

Cancer in pregnancy is less common, however its frequency is increasing due to delayed onset of childbearing. Pregnant patients with cancer can experience high frequency of moderate to severe cancer pain. It can be challenging to manage cancer pain due to the complexity with assessment and treatment as many of the analgesics are avoided. There exists limited research and few guidelines by national and international organizations to guide effective opioid management among pregnant women or pregnant woman with cancer pain. Pregnant patients with cancer need to be managed by interdisciplinary team with multimodal analgesia including opioids, adjuvants, non-pharmacological interventions for optimal care of these patient and later the neonate. Opioids such as morphine may be considered for the management of severe cancer pain during pregnancy. It is important to prescribe the lowest effective dose and quantity of opioids after taking into consideration the risk/benefit to patient-infant dyad. Neonatal abstinence syndrome should be anticipated after delivery and carefully managed in intensive care, if possible. Further research is needed. In this review article we describe the challenges of managing cancer pain in pregnant woman and the current approach of opioids management for cancer pain in these patients using a case report.

Helpfulness of Question Prompt Sheet for Patient-Physician Communication Among Patients With Advanced Cancer: A Randomized Clinical Trial.

Importance: There are few robust evaluations of disease-specific question prompt sheets (QPS) in patient-physician communication among patients with advanced cancer. Objective: To compare the patient perception of helpfulness, global evaluation, and preference for the QPS vs a general information sheet (GIS), and to examine the effect of the QPS on participants' anxiety, participants' speaking time, number of questions asked, and length of the clinical encounter. Design, Setting, and Participants: This controlled, double-blind randomized clinical trial was conducted at an outpatient palliative and supportive care clinic in a cancer center in the US. Eligible patients were 18 years or older, had a cancer diagnosis, and were undergoing their first outpatient consultation visit with a palliative care physician from September 1, 2017, to May 31, 2019. Data analysis used a modified intention-to-treat design. Data were analyzed from May 18 to June 27, 2022. Intervention: QPS, a 25-item list of questions developed by expert palliative care clinicians using a Delphi process and tested among ambulatory advanced cancer patients. The control was GIS, generic information material given routinely to patients seen at the supportive care clinic. Main Outcomes and Measures: The main outcome was patient perception of helpfulness. Secondary outcomes included global evaluation and preference of QPS compared with GIS immediately after the encounter. Results: A total of 130 patients (mean [SD] age, 58.6 [13.3] years; 79 [60.8%] female) were randomized to receive either QPS (67 patients [51.5%]) or GIS (63 patients [48.5%]). Patients considered QPS and GIS equally helpful, with no statistically significant difference (mean [SD] helpfulness score, 7.2 [2.3] points vs 7.1 [2.7] points; P = .79). The QPS group, compared with the GIS group, had a higher global positive view of the material (mean [SD] global perception score, 7.1 [1.3] vs 6.5 [1.7]; P = .03) and felt it prompted them more to generate new questions (mean [SD] rating, 7.0 [2.9] vs 5.3 [3.5]; P = .005). Of 47 patients asked their preference between the items, more participants preferred the QPS to the GIS in communicating with their physicians (24 patients [51.1%] vs 7 patients [14.9%]; P = .01) at the 4-week follow-up. No significant differences between the QPS and GIS groups were observed regarding participant anxiety, speaking time, number of questions asked, or consultation length (eg, mean [SD] anxiety rating, 2.3 [3.7] vs 1.6 [2.7]; P = .19). Conclusions and Relevance: In this randomized clinical trial, participants perceived both QPS and GIS as equally helpful, but they had a more positive global view of and preferred the QPS. QPS facilitated generation of new questions without increasing patient anxiety nor prolonging the consultation. The findings provide support for increased adoption and integration of QPS into routine oncologic care. Trial Registration: ClinicalTrials.gov Identifier: NCT03287492.

Decision-Making Preferences among Advanced Cancer Patients in a Palliative Setting in Jordan.

Understanding patients' decision-making preferences is crucial for enhancing patients' outcomes. The current study aims to identify Jordanian advanced cancer patients' preferred decision-making and to explore the associated variables of the passive decision-making preference. We used a cross-sectional survey design. Patients with advanced cancer referred to the palliative care clinic at a tertiary cancer center were recruited. We measured patients' decision-making preferences using the Control Preference Scale. Patients' satisfaction with decision-making was assessed with the Satisfaction with Decision Scale. Cohen's kappa statistic was used to assess the agreement between decision-control preferences and actual decision-making, and the bivariate analysis with 95% CI and the univariate and multivariate logistic regression were used to examine the association and predictors of the demographical and clinical characteristics of the participants and the participants' decision-control preferences, respectively. A total of 200 patients completed the survey. The patients' median age was 49.8 years, and 115 (57.5%) were female. Of them, 81 (40.5%) preferred passive decision control, and 70 (35%) and 49 (24.5%) preferred shared and active decision control, respectively. Less educated participants, females, and Muslim patients were found to have a statistically significant association with passive decision-control preferences. Univariate logistic regression analysis showed that, being a male (p = 0.003), highly educated (p = 0.018), and a Christian (p = 0.006) were statistically significant correlates of active decision-control preferences. Meanwhile, the multivariate logistic regression analysis showed that being a male or a Christian were the only statistically significant predictors of active participants' decision-control preferences. Around 168 (84%) of participants were satisfied with the way decisions were made, 164 (82%) of patients were satisfied with the actual decisions made, and 143 (71.5%) were satisfied with the shared information. The agreement level between decision-making preferences and actual decision practices was significant (ⱪ coefficient = 0.69; 95% CI = 0.59 to 0.79). The study's results demonstrate that a passive decision-control preference was prominent among patients with advanced cancer in Jordan. Further studies are needed to evaluate decision-control preference for additional variables, such as patients' psychosocial and spiritual factors, communication, and information sharing preferences, throughout the cancer trajectory so as to inform policies and improve practice.

Treatment of Cancer-related-Fatigue in Acute Hematological Malignancies: Results of a Feasibility Study of using Cognitive Behavioral Therapy.

BACKGROUND: Despite cancer related fatigue (CRF) being the most common, and debilitating symptom in patients with recently diagnosed acute hematological malignancies (HM), there are limited effective treatments for CRF in HM. The aim of this study was to determine the feasibility of cognitive behavioral therapy (CBT) for CRF in HM. METHODS: In this preliminary longitudinal prospective study, HM patients diagnosed a median of one month previously with moderate to severe fatigue were enrolled. Patients received CBT in seven weekly sessions for eight weeks. Change in Functional Assessment of Cancer Illness Therapy (FACIT) - Fatigue (primary), FACT-G, Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety Depression Scale (HADS), M.D. Anderson Symptom Inventory - Acute Myeloid Leukemia (MDASI-AML/MDS), and Herth Hope Index (HHI) were analyzed. RESULTS: Twenty-seven of 36 (75 %) patients were evaluable. Adherence and satisfaction rates to the CBT intervention were 78.6% (95% CI 67.2%, 89.9%), and 92% (95% CI 76.7%, 98.3%) respectively. The median age 66, 64% female, the most common HM was AML (60%), median FACIT-F was 27. The mean (SD) improvement at end eight weeks for FACIT-F was 5.5(13.6), Cohen δ 0.4, P=0.046; and for PSQI total was 2.9 (3), Cohen δ -1, P=0.006. We also found significant improvement in HADS anxiety -2.7(4.5), P=0.049, MDASI Sleep -1.8(3.0), P=0.022, MDASI mean module symptom severity -0.7(1.6), P=0.006. However, no significant improvements were found in FACT-G, HHI, and HADS-depression scores. CONCLUSIONS: The use of CBT was feasible with improvement of CRF, sleep quality, and anxiety scores in HM. Randomized controlled trials are justified.

Perception of subjective lived experiences of individuals with anorexia-cachexia in patients with advanced lung cancer.

Objective: Cancer cachexia (CC) is a frequent and debilitating syndrome in patients with cancer. It has serious implications for patients, extending beyond physical problems into psychological, and social domains. The objective of our study was to qualitatively understand the experiences related to CC in patients with advanced lung cancer. Methods: Patients with advanced lung cancer with anorexia (≤ 37 points on Functional Assessment of Anorexia/Cachexia Treatment-ACS) and weight loss were eligible. Patients participated in semi-structured interviews prior to study treatment (n = 19). Qualitative analysis was conducted using interpretative phenomenological approach. Results: Two super-ordinate themes emerged (anorexia and weight loss). Patients reported experiencing distress related to anorexia, weight loss, lack of social eating, worsening function, body image, and eating habits. The encouragement to eat by the family was often distressing to the patient. The treatment recommendations by their oncologist for anorexia and weight loss was felt inadequate. Patients felt that the treatment for CC should improve appetite and weight gain as well as their mood and be independent. Conclusions: The findings of the study suggests that anorexia and weight loss results in high levels of distress due to their effects on physical and psychosocial domains. Further studies are needed to better understand the experience of anorexia and weight loss to develop strategies to effectively treat CC. Trial registration: NCT03637816.

Open-Label Placebo for the Treatment of Cancer-Related Fatigue in Patients with Advanced Cancer: A Randomized Controlled Trial.

BACKGROUND: The purpose of this study was to determine the effects of an open-labeled placebo (OLP) compared to a waitlist control (WL) in reducing cancer-related fatigue (CRF) in patients with advanced cancer using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). MATERIALS AND METHODS: In this randomized controlled trial, patients with fatigue ≥4/10 on Edmonton Symptom Assessment Scale (ESAS) were randomized to OLP one tablet twice a day or WL for 7 days. On day 8, patients of both arms received a placebo for 3 weeks. Changes in FACIT-F from baseline to day 8 (primary outcome) and at day 29, were assessed. Secondary outcomes included FACT-G, Multidimensional Fatigue Symptom Inventory-SF, Fatigue cluster (defined as a composite of ESAS fatigue, pain, and depression), Center for epidemiologic studies-depression, Godin leisure-time physical activity questionnaire, and global symptom evaluation. RESULTS: A total of 84/90 (93%) patients were evaluable. The mean (SD) FACIT-F change at day 8 was 6.6 (7.6) after OLP, vs. 2.1 (9.4) after WL (P = .016). On days 15 and 29, when all patients received OLP, there was a significant improvement in CRF and no difference between arms. There was also a significant improvement in ESAS fatigue, and fatigue cluster score in the OLP arm on day 8 of the study (0.029, and 0.044, respectively). There were no significant differences in other secondary outcomes and adverse events between groups. CONCLUSIONS: Open-labeled placebo was efficacious in reducing CRF and fatigue clusters in fatigued advanced cancer patients at the end of 1 week. The improvement in fatigue was maintained for 4 weeks. Further studies are needed.

Interdisciplinary intervention for the management of nonmedical opioid use among patients with cancer pain.

BACKGROUND: Few studies have assessed interventions aimed at managing nonmedical opioid use (NMOU) behavior among patients with cancer. The authors developed the Compassionate High-Alert Team (CHAT) intervention to manage patients receiving opioids for cancer pain who demonstrate NMOU behavior. The objective of this study was to determine the change in frequency of NMOU behaviors, pain intensity, and opioid requirements among those who received the intervention. METHODS: A total of 130 patients receiving opioids for cancer pain that had documented evidence of NMOU and received the CHAT intervention were reviewed. Demographic and clinical information such as NMOU behaviors, pain scores, and morphine equivalent daily dose at baseline, 3, and 6 months post-intervention was obtained. RESULTS: NMOU behaviors significantly decreased from a median (interquartile range) of 2 (1-3) at baseline to 0 (0-1) at both 3 and 6 months post-intervention (p < .001). A total of 45 of 75 (60%) and 31 of 50 (62%) of CHAT recipients achieved complete response to the intervention at 3 and 6 months, respectively. Higher baseline number of NMOU behaviors was independently associated with patient response to the intervention (odds ratio [OR], 1.97; 95% confidence interval [CI],1.09-4.28, p = .049 at 3 months; OR, 2.5; 95% CI, 1.20-6.47, p = .03 at 6 months). The median pain score decreased from 7 at baseline to 6 at both 3 and 6 months (p = .01). Morphine equivalent daily dose did not significantly change during that same period (143 mg/day vs. 139 mg/day, p = .13). CONCLUSIONS: Most patients who received the CHAT intervention improved in their NMOU behaviors and pain intensity scores 3 and 6 months post-intervention. These preliminary findings support the efficacy of CHAT in managing patients receiving opioids for cancer pain who demonstrate NMOU behavior.

Do Patients Benefit from a Trial of Corticosteroids at the End of Life?

OPINION STATEMENT: Patients with advanced cancer in the last 6 months of their lives have a higher frequency of distressing and debilitating physical and psychosocial symptoms such as cancer pain, cancer-related fatigue (CRF), anorexia, shortness of breath, poor sleep, anxiety, and depression. Often these symptoms significantly impact the patients' quality of life, and therefore require prompt assessment and effective treatment. There are specific treatments for certain distressing cancer-related symptoms (e.g., opioids for pain), but for the other symptoms such as CRF, anorexia-cachexia, and shortness of breath, there are limited or no evidence-based treatments. Also, in the management of cancer pain in this population, many patients are refractory to opioids. Hence, corticosteroids are one of the most common adjuvant medications prescribed for the management of this distressing symptom. However, there is limited evidence in regard to the effectiveness of corticosteroids in the improvement of the symptoms, side-effect profile, most optimal duration of use, dose, type of steroid, and most recently, the use with immunotherapy in advanced cancer patients at the end of life. These factors significantly limit the use of this important medication in terminally ill cancer patients. Further research is therefore critical to provide the optimal prescription of corticosteroids in this highly distressed population.

Frequency and Prediction of Burnout Among Physicians Who Completed Palliative Care Fellowship Training - A 10 Year Survey.

CONTEXT: Palliative Care (PC) physicians are vulnerable to burnout given the nature of practice. Reports suggest that burnout frequency is variable across different countries. OBJECTIVE: The main objective of our study was to determine knowledge, attitudes and frequency of burnout among Hospice and Palliative Medicine (HPM) Fellowship graduates trained at a comprehensive cancer center. METHODS: We conducted a survey to determine the knowledge, attitudes, and frequency of burnout in former fellows, consisting of the Maslach Burnout Inventory (MBI) and 41 custom questions. Palliative care fellows who trained at a Comprehensive Cancer Center from 2008 to 2018 were included in the survey. RESULTS: Eighty-four percent of the 52 eligible physicians completed surveys. Median age was 38 years, with 68% females. Seventy-seven percent practiced PC more than 50% of time. Median practice duration was four years, and 84% were board certified. Most common disease types treated were cancer (89%), cardiac (43%) and pulmonary (43%). Burnout rate was high at 52% (n=20). The median scores for emotional exhaustion were 25.5, depersonalization 9, and personal accomplishment 48. Female gender (P=0.07) and having administration as a component in the job description (P=0.044) were associated with risk of burnout. Clinical care setting, work hours/week, frequency of weekend calls, and size of team were not significantly associated with burnout. CONCLUSION: Burnout among former fellows trained in HPM between 2008 and 2018 is high. More research is needed to develop strategies to better prevent and manage burnout among HPM fellowship trained PC physicians.

Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study.

PURPOSE: Cancer-related fatigue (CRF) is the most frequent and debilitating symptom in patients with advanced cancer. There are limited effective treatments for CRF. The objective of this prospective longitudinal study was to evaluate the change in CRF at Day 43 after treatment with combination therapy of oral Anamorelin 100 mg daily with physical activity and nutrition counseling. METHODS: In this study, patients with CRF [≤ 34 Functional Assessment of Chronic Illness Therapy-Fatigue subscales(FACIT-F)] received Anamorelin 100 mg orally daily with standardized physical activity and nutrition counseling for 43 days. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Anorexia Cachexia(FAACT-ACS), Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), Patient-Reported Outcomes Measurement Information System(PROMIS-Fatigue), body composition, and physical performance tests were assessed at baseline, Day 15, 29, and 43. Frequency and type of side effects were determined by NCI CTAE 4.0.(NCT03035409). RESULTS: 28/45 (62%) of patients dosed were evaluable at Day 43. The mean, SD for FACIT-F subscale improvement from baseline was 4.89 (± 13.07), P = .058, MFSI-SF (G) - 3.46 (± 6.86), P = 0.013, PROMIS-fatigue - 4.14 (± 7.88), P = 0.010, FAACT ACS 3.48 (± 8.13), P = 0.035. Godin Liesure-Time physical activity questionnaire 7.41 (± 16.50), P = 0.038. Weight (kg) 1.81 (± 2.63), P = 0.005, and Lean Body Mass 1.54 (± 1.85), P = 0.001, IGF-1 36.50 (± 48.76), P = 0.015. There was no significant improvement in physical performance outcomes. No adverse events > grade 3 related to the study drug were reported. CONCLUSION: The use of the combination therapy was associated with improvement of CRF (FACIT-F fatigue, PROMIS-fatigue, MFSI-SF-general), activity (Godin-leisure time), anorexia (FAACT), body composition, and IGF-1 levels. Further studies using combination therapy for CRF are justified.

Frequency and characteristics of advanced cancer patients with COVID + ve status among inpatient supportive care consults during the pandemic: experience from a tertiary cancer center.

PURPOSE: There is limited literature available regards the frequency and characteristics of COVID-19 + ve status among advanced cancer patients referred to an inpatient supportive care consultation(PC) at a tertiary cancer center. Our study aimed to determine the frequency and characteristics of COVID-19 + ve cancer patients seen by PC. METHODS: Advanced cancer patients seen as a consult by PC between June 15 and September 25, 2020, at MD Anderson Cancer Center were eligible for the study. We evaluated the patient demographics, clinical characteristics including symptoms(ESAS), delirium(MDAS), COVID + status prior to, and after PC referral(converters), and type of PC delivery(in person or virtual care). RESULTS: Sixty-six out of 1380 (4.8%) PC consults were COVID-19 + ve: 42 prior to PC (79%), and 14 (21%) were COVID-19 + ve after the PC (converters). COVID-19 + PC patients had lower depression (P = .035), spiritual distress (P = .003), and were more seen frequently virtually (P < 0.001). There was no significant difference between COVID-19-ve patients and converters. Converters had higher symptom distress (P = 0.007), lower delirium (P = 0.014), and were referred earlier (P = .011) compared to COVID + PC patients diagnosed prior to PC consult. Overall, patients seen virtually compared in-person by PC were younger (P = 0.02) and had lower delirium (P = 0.007). CONCLUSION: The burden of COVID-19 + status among patients referred to PC was low. COVID-19 + ve patients had more frequent virtual visits, lower depression, and spiritual distress scores. Patient seen virtually were significantly younger and had lower delirium. During a new pandemic, universal virtual care might be emphasized especially at initial encounters after admission and further research is needed on the potential efficacy of this intervention.

Sleep disturbance in cancer patients referred to an ambulatory integrative oncology consultation.

BACKGROUND: Sleep disturbance (SD) is highly prevalent in oncology and negatively affects quality of life and mortality. Evidence supports the use of integrative oncology (IO) practices to treat SD, but there is limited published data on the characteristics of SD and factors associated with SD in IO. We determined the prevalence, severity, and factors associated with SD among cancer patients seen in an ambulatory IO consultation. METHODS: Patients with cancer referred for initial outpatient IO consultation in 2017 were eligible. Patient demographics, clinical characteristics, and patient-reported outcomes (Edmonton Symptom Assessment Scale (ESAS), Measure Yourself Concerns and Wellbeing (MYCaW), PROMIS-10) were retrospectively reviewed. RESULTS: One thousand five hundred twenty patients were included in the analysis. The majority (70%) were women with breast cancer (42%). Nine hundred seventy-one (64%) patients reported significant SD with ESAS Sleep ≥ 4, yet only 11% expressed poor sleep as their primary or secondary concern for the IO consultation. The median SD (IQR) was 5 (3,7). ESAS scores for fatigue (adjusted OR 1.16; CI 1.07-1.26, p < 0.001), pain (adjusted OR 1.07; CI 1.00-1.15, p < 0.05), hot flashes (adjusted OR 1.14; CI 1.07-1.22, p < 0.001), well-being (adjusted OR 1.33; CI 1.22-1.46, p < 0.001), and psychological distress score (anxiety and depression) (adjusted OR 1.16; CI 1.01-1.11, p < 0.01) were independently associated with SD in multivariate analysis. Acupuncture was the most frequent intervention prescribed, 175 (35%). Other modalities included oncology massage (15%), health psychology (5%), and meditation (1%). CONCLUSIONS: Although 64% of patients seeking IO consultation reported clinically significant SD, only 11% were seeking integrative approaches for managing SD. ESAS fatigue, hot flashes, well-being, and psychological symptoms were significantly associated with SD.

Meta-Analysis of Pharmacological, Nutraceutical and Phytopharmaceutical Interventions for the Treatment of Cancer Related Fatigue.

Purpose: In this study we aimed to estimate the effectiveness of pharmacological, nutraceutical, and phytopharmaceutical treatments on CRF. Methods: Ovid MEDLINE, Ovid Embase, Ovid Psych info, CINHAHL and Cochrane Library databases were searched up to 30 September 2021. Randomized controlled trials of pharmacological, nutraceutical and phytopharmaceutical interventions for treatment of CRF for at least one week duration and have used valid tool to assess severity of CRF as a primary or secondary outcome were considered. Results: 32 eligible studies (4896 patients) were reviewed. For the overall meta-analysis, the random effect models yielded the treatment effect (95% CI) of −0.29 (−0.48,−0.09), p < 0.001. The meta-analysis did not show significant reduction of CRF with treatment with ginseng (n = 6), guarana (n = 3), megestrol (n = 2), mistletoe (n = 3), psychostimulants (n = 14), SSRI/antidepressants (n = 2). Corticosteroids (n = 2) showed significant reduction in CRF with treatment effects of 0.94 (−1.21, −0.67), p <0.0001, respectively. Conclusions: In this study, overall meta-analysis of all studies demonstrates significant reduction of CRF using Pharmacological, Nutraceutical and Phytopharmaceutical interventions with a pooled standardized treatment effect of −0.29. Metanalysis of Corticosteroids studies showed significant reduction in CRF. Further studies are needed.

Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial.

BACKGROUND: Despite the high frequency of cancer-related fatigue (CRF) and its debilitating effects on the quality of life of patients with advanced cancer, there are limited treatment options available. Treatments including physical activity (PA) or dexamethasone (Dex) improve CRF; however, they have lower adherence rates (PA) or long-term adverse effects (Dex). The aim of this study was to determine the feasibility of and preliminary results for the combination of PA and Dex in improving CRF. METHODS: In this phase II randomized controlled trial, patients with advanced cancer and CRF scores of ≥4/10 on the Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks with either 4 mg of Dex (LoDex arm) or 8 mg of Dex (HiDex arm) twice a day for 7 days. Feasibility and change in the Functional Assessment of Cancer Illness Therapy-Fatigue subscale (FACIT-F) from baseline to day 8 and day 29 (primary outcome) were assessed. Secondary outcomes included changes in fatigue dimensions (FACIT-General, Patient-Reported Outcomes Measurement Information System [PROMIS]-Fatigue). RESULTS: A total of 60 of 67 (90%) patients were evaluable. All patients were adherent to study medication. We found that 84% and 65% of patients in the LoDex arm and 96% and 68% of patients in the HiDex arm were adherent to aerobic and resistance exercise, respectively. The FACIT-F effect size in the LoDex arm was 0.90 (P<.001) and 0.92 (P<.001) and the effect size in the HiDex arm was 0.86 and 1.03 (P<.001 for both) at days 8 and 29, respectively. We found significant improvements in the Functional Assessment of Cancer Therapy-Physical (P≤.013) and the PROMIS-Fatigue (P≤.003) at days 8 and 29 in both arms. Mixed-model analysis showed a significant improvement in the FACIT-F scores at day 8 (P<.001), day 15 (P<.001), and day 29 (P=.002). Changes in the FACIT-F scores were not significantly different between patients in the 2 arms (P=.86). CONCLUSIONS: Our study found that the combination therapy of PA with Dex was feasible and resulted in the improvement of CRF. The improvement was seen for up to 3 weeks after the discontinuation of Dex. Further larger studies are justified. CLINICALTRIALS: gov identifier: NCT02491632.

Evaluation and Management of Sleep and Circadian Rhythm Disturbance in Cancer.

OPINION STATEMENT: Sleep and circadian rhythm disturbance are among the most commonly experienced symptoms in patients with cancer. These disturbances occur throughout the spectrum of cancer care from diagnosis, treatment, and long into survivorship. The pathogenesis of these symptoms and disturbances is based on common inflammatory pathways related to cancer and its' treatments. The evaluation of sleep and circadian disorders requires an understanding of how these symptoms cluster with other cancer-related symptoms and potentiate each other. A thorough evaluation of these symptoms and disorders utilizing validated diagnostic tools, directed review of clinical information, and diagnostic testing is recommended. Treatment of sleep and circadian disturbance in cancer patients should be based on the findings of a detailed evaluation, including specific treatment of primary sleep and circadian disorders, and utilize integrative and personalised management of cancer-related symptoms through multiple pharmacologic and non-pharmacologic modalities. Recognition, evaluation, and treatment of sleep and circadian rhythm disturbance in cancer may lead to improved symptom management, quality of life, and outcomes.