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

2021 ◽  
pp. 1-9
Author(s):  
Sriram Yennurajalingam ◽  
Vicente Valero ◽  
Zhanni Lu ◽  
Diane D. Liu ◽  
Naifa L. Busaidy ◽  
...  
Keyword(s):  
Physical Activity ◽  
Combination Therapy ◽  
Advanced Cancer ◽  
Phase Ii ◽  
Functional Assessment ◽  
Effect Size ◽  
Controlled Trial ◽  
Cancer Related Fatigue ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

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.

Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
Marvin Omar Delgado-Guay ◽  
Janet Bull ◽  
Alexandria T. Phan ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Primary Objective ◽  
Controlled Study ◽  
Advanced Cancer Patients ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

Effects of high-dose Asian ginseng (Panax ginseng) to improve cancer-related fatigue: Results of a double-blind, placebo-controlled randomized controlled trial.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 209-209 ◽  
Author(s):  
Sriram Yennu ◽  
Nizar M. Tannir ◽  
Janet L. Williams ◽  
Kenneth R. Hess ◽  
Susan Frisbee-Hume ◽  
...  
Keyword(s):  
Functional Assessment ◽  
Controlled Trial ◽  
Depression Scale ◽  
Primary Objective ◽  
High Dose ◽  
Cancer Type ◽  
Double Blind ◽  
Ginseng Extract ◽  
Cancer Related Fatigue ◽  
Edmonton Symptom Assessment Scale

209 Background: Cancer related fatigue (CRF) is the most common and disabling symptom in cancer.Panax ginseng extract (PG) is frequently used as a nutraceutical treatment for fatigue. There are no well-powered placebo-controlled trials that used validated CRF outcome measures to investigate of PG effects in cancer patients. The primary objective of this trial was to evaluate the effects oral PG versus Placebo (PL) for CRF. Methods: Patients with cancer fatigue ≥ 4/10 on Edmonton Symptom Assessment Scale (ESAS) were eligible. Patients were randomized to either 400mg of standardized PG or matching PL orally twice a day for 28 days. The primary endpoint was change in the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) fatigue subscale from baseline to Day 28. Secondary outcomes were Functional Assessment of Cancer Therapy-General (FACT-G), Hospital Anxiety and Depression Scale (HADS), and ESAS. Results: Total evaluable patients were 112 (56 for PG and PL groups). No significant differences in baseline characteristics between the two groups except cancer type (p = 0.002). There was significant improvement in FACIT fatigue and ESAS fatigue scores in PG and PL groups at Day 15 and Day 29. The mean (SD) of FACIT-F fatigue scores at baseline, Day 15, and Day 29 were 22.6 (10.4), 29.8(10.7), 30.1 (11.6) and 23.8 (9.1), 30.0 (10.1), 30.4 (11.6) for PG and PL respectively. Mean (SD) improvement in the FACIT-F subscale at Day 29 was not significantly different in PG than in the PL group [7.5 (12.7) vs 6.5 (9.9), P = 0.67]. Mean (SD) improvement in the ESAS fatigue, FACT-G, and HADS at Day 29 were also not significantly different in PG than in the PL group. In a multiple linear model analysis, the change in FACIT-F fatigue from Day 0 to Day 29 was negatively correlated with baseline FACIT-F fatigue (p = 0.0005), baseline HADS score (p = 0.032), and male gender (p = 0.023). There were a significantly higher number of any grade of toxicities in PL group than in PG group (33/62 vs. 28/64, p = 0.024). Conclusions: Both PG and Placebo result in a significant improvement in CRF at Day 15 and Day 29. PG was not significantly superior to placebo after 4 weeks of treatment. Further studies are needed. Clinical trial information: NCT01375114.

High/low dose dexamethasone with physical activity for cancer-related fatigue in patients with advanced cancer: A phase II randomized double blind study.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 110-110
Author(s):  
Sriram Yennu ◽  
Vicente Valero ◽  
Bora Lim ◽  
Daniel J. Booser ◽  
Carolina Diaz Hernandez ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Glucose ◽  
Sleep Quality ◽  
Resistance Exercise ◽  
Advanced Cancer ◽  
Fasting Blood Glucose ◽  
Cancer Related Fatigue ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale ◽  
Total P

110 Background: Cancer-related-fatigue (CRF) is the most debilitating symptom in patients with advanced cancer. Physical activity (PA) improves CRF with lower adherence in advanced cancer. Dexamethasone (Dex) improves CRF but has long-term side effects. The purpose of the study was to determine whether a brief course of Dex improves adherence to PA for CRF management. Methods: Advanced cancer patients with CRF ≥ 4/10 on Edmonton Symptom Assessment Scale (ESAS) were eligible. Patients were randomized to either 4mg of Dex (LoDex) or 8mg of Dex (HiDex) orally BID for 7 days Plus standardized aerobic and resistance exercise for 4 weeks. Change in the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) fatigue subscale from baseline to Day 8 (primary outcome) and Day 29 were assessed. Secondary outcomes included changes in fatigue (ESAS, PROMIS, MFSI), Sleep Quality (PSQI), fasting blood glucose, and myopathy. Results: Total evaluable patients were 60 (31 LoDex and 29 HiDex arms). The study was feasible (N = 60/67 were evaluable); 84% and 65% LoDex, and 96% and 68% Hi Dex were adherent to aerobic and resistance exercise, respectively [All Patients were adherent to study medication]. There was no significant difference in grade 3+ AE’s between the two arms (P = 0. 92). The FACIT fatigue subscale Cohen’s d in Lo Dex was 0.90 (P < 0.001) and 0.94(P < 0.001); and Hi Dex was 0.86(P < 0.001); and 1.05(P < 0.001) at Day 8 and Day 29, respectively. Similar improvement was found for ESAS Fatigue (P < 0.001), MFSI total (P = 0.005), and PROMIS –fatigue total (P = 0.005). Mixed model analysis showed significant improvement in FACIT-F fatigue scores at Day 8 (P = 0.0006), Day 15 (P = 0.0002), and D (P = 0.0018). There was no significant difference between the two arms at Day 8 and Day 29 in fatigue scores, myopathy, fasting blood glucose levels, symptom distress, and sleep quality scores. Conclusions: Short course of dexamethasone Plus physical activity resulted in sustained and robust improvement in CRF outcomes for upto 3 weeks after discontinuation of steroids suggesting possible priming effects of steroids helped to sustain physical activity. Further larger studies are justified. Clinical trial information: NCT02491632.

scholarly journals Changes in fatigue, barriers, and predictors towards physical activity in advanced cancer patients over a period of 12 months—a comparative study

2021 ◽  
Author(s):  
J. Frikkel ◽  
M. Beckmann ◽  
N. De Lazzari ◽  
M. Götte ◽  
S. Kasper ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Physical Functioning ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Advanced Cancer Patients ◽  
Psychological Conditions ◽  
Patient Reported

Abstract Purpose Physical activity (PA) is recommended to improve advanced cancer patients’ (ACP) physical functioning, fatigue, and quality of life. Yet, little is known about ACPs’ attitude towards PA and its influence on fatigue and depressiveness over a longer period. This prospective, non-interventional cohort study examined ACPs’ fatigue, depression, motivation, and barriers towards PA before and after 12 months of treatment among ACP Methods Outpatients with incurable cancer receiving treatment at a German Comprehensive Cancer Center reporting moderate/severe weakness/tiredness during self-assessment via MIDOS II were enrolled. Fatigue (FACT-F), depression (PHQ-8), cancer-related parameters, self-assessed PA behavior, motivation for and barriers against PA were evaluated (T0). Follow-up data was acquired after 12 months (T1) using the same questionnaire. Results At follow-up, fatigue (p=0.017) and depressiveness (p=0.015) had increased in clinical relevant extent. Physically active ACP did not show significant progress of FACT-F (p=0.836) or PHQ-8 (p=0.799). Patient-reported barriers towards PA remained stable. Logistic regression analyses identified motivation as a positive predictor for PA at both time points (T0, β=2.152, p=0.017; T1, β =2.264, p=0.009). Clinically relevant depression was a negative predictor for PA at T0 and T1 (T0, β=−3.187, p=0.044; T1, β=−3.521, p=0.041). Conclusion Our findings emphasize the importance of psychological conditions in physical activity behavior of ACP. Since psychological conditions seem to worsen over time, early integration of treatment is necessary. By combining therapy approaches of cognitive behavioral therapy and exercise in interdisciplinary care programs, the two treatment options might reinforce each other and sustainably improve ACPs’ fatigue, physical functioning, and QoL. Trial registration German Register of Clinical Trials, DRKS00012514, registration date: 30.05.2017

scholarly journals Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Breast Cancer

2005 ◽  
Vol 23 (25) ◽  
pp. 6027-6036 ◽  
Author(s):  
Patsy Yates ◽  
Sanchia Aranda ◽  
Maryanne Hargraves ◽  
Bev Mirolo ◽  
Alexandra Clavarino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Functional Assessment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Numeric Rating

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

scholarly journals An Activity Tracker–Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials) (Preprint)

2021 ◽  
Author(s):  
Franziska Hauth ◽  
Barbara Gehler ◽  
Andreas Michael Nieß ◽  
Katharina Fischer ◽  
Andreas Toepell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Functional Assessment ◽  
Exercise Program ◽  
Daily Step ◽  
Patients With Cancer ◽  
Activity Tracker ◽  
Cancer Related Fatigue ◽  
Daily Step Count

BACKGROUND The positive impact that physical activity has on patients with cancer has been shown in several studies over recent years. However, supervised physical activity programs have several limitations, including costs and availability. Therefore, our study proposes a novel approach for the implementation of a patient-executed, activity tracker–guided exercise program to bridge this gap. OBJECTIVE Our trial aims to investigate the impact that an activity tracker–guided, patient-executed exercise program for patients undergoing radiotherapy has on cancer-related fatigue, health-related quality of life, and preoperative health status. METHODS Patients receiving postoperative radiotherapy for breast cancer (OnkoFit I trial) or neoadjuvant, definitive, or postoperative treatment for other types of solid tumors (OnkoFit II trial) will be randomized (1:1:1) into 3-arm studies. Target accrual is 201 patients in each trial (50 patients per year). After providing informed consent, patients will be randomized into a standard care arm (arm A) or 1 of 2 interventional arms (arms B and C). Patients in arms B and C will wear an activity tracker and record their daily step count in a diary. Patients in arm C will receive personalized weekly targets for their physical activity. No further instructions will be given to patients in arm B. The target daily step goals for patients in arm C will be adjusted weekly and will be increased by 10% of the average daily step count of the past week until they reach a maximum of 6000 steps per day. Patients in arm A will not be provided with an activity tracker. The primary end point of the OnkoFit I trial is cancer-related fatigue at 3 months after the completion of radiotherapy. This will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. For the OnkoFit II trial, the primary end point is the overall quality of life, which will be assessed with the Functional Assessment of Cancer Therapy-General sum score at 6 months after treatment to allow for recovery after possible surgery. In parallel, blood samples from before, during, and after treatment will be collected in order to assess inflammatory markers. RESULTS Recruitment for both trials started on August 1, 2020, and to date, 49 and 12 patients have been included in the OnkoFit I and OnkoFit II trials, respectively. Both trials were approved by the institutional review board prior to their initiation. CONCLUSIONS The OnkoFit trials test an innovative, personalized approach for the implementation of an activity tracker–guided training program for patients with cancer during radiotherapy. The program requires only a limited amount of resources. CLINICALTRIAL ClinicalTrials.gov NCT04506476; https://clinicaltrials.gov/ct2/show/NCT04506476. ClinicalTrials.gov NCT04517019; https://clinicaltrials.gov/ct2/show/NCT04517019. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/28524

scholarly journals Effects of Melatonin on Appetite and Other Symptoms in Patients With Advanced Cancer and Cachexia: A Double-Blind Placebo-Controlled Trial

2013 ◽  
Vol 31 (10) ◽  
pp. 1271-1276 ◽  
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Null Hypothesis ◽  
Controlled Trial ◽  
Double Blind ◽  
Patients With Cancer ◽  
Edmonton Symptom Assessment Scale

Purpose Prior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. Patients and Methods We performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores ≥ 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss ≥ 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z < 0.39 (P ≥ .348) and reject the null hypothesis if z > 2.54 (P ≤ .0056). Results After interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28. Conclusion In cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo.

A Physical Activity Intervention for Brazilian Students From Low Human Development Index Areas: A Cluster-Randomized Controlled Trial

2016 ◽  
Vol 13 (11) ◽  
pp. 1174-1182 ◽  
Author(s):  
Valter C. Barbosa Filho ◽  
Kelly Samara da Silva ◽  
Jorge Mota ◽  
Carmem Beck ◽  
Adair da Silva Lopes
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Human Development ◽  
Effect Size ◽  
Human Development Index ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Development Index ◽  
Randomized Controlled ◽  
Cluster Randomized

Background:Promoting physical activity (PA) in low- and middle-income countries is an important public health topic as well as a challenge for practice. This study aimed to assess the effect of a school-based intervention on different PA-related variables among students.Methods:This cluster-randomized-controlled trial included 548 students in the intervention group and 537 in the control group (11–18 years-old) from 6 schools in neighborhoods with low Human Development Index (0.170–0.491) in Fortaleza, Brazil. The intervention included strategies focused on training teachers, opportunities for PA in the school environment and health education. Variables measured at baseline and again at the 4-months follow-up included the weekly time in different types of moderate-to-vigorous PA (MVPA), preference for PA during leisure-time, PA behavioral change stage and active commuting to school. Generalized linear models and binary logistic regressions were used.Results:An intervention effect was found by increasing the weekly time in MVPA (effect size = 0.17), popular games (effect size = 0.35), and the amount of PA per week (effect size = 0.27) among students (all P < .05).Conclusions:The intervention was effective in promoting improvements in some PA outcomes, but the changes were not sufficient to increase the proportion of those meeting PA recommendations.

scholarly journals An Activity Tracker–Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials)

10.2196/28524 ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. e28524
Author(s):  
Franziska Hauth ◽  
Barbara Gehler ◽  
Andreas Michael Nieß ◽  
Katharina Fischer ◽  
Andreas Toepell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Functional Assessment ◽  
Exercise Program ◽  
Daily Step ◽  
Patients With Cancer ◽  
Activity Tracker ◽  
Cancer Related Fatigue ◽  
Daily Step Count

Background The positive impact that physical activity has on patients with cancer has been shown in several studies over recent years. However, supervised physical activity programs have several limitations, including costs and availability. Therefore, our study proposes a novel approach for the implementation of a patient-executed, activity tracker–guided exercise program to bridge this gap. Objective Our trial aims to investigate the impact that an activity tracker–guided, patient-executed exercise program for patients undergoing radiotherapy has on cancer-related fatigue, health-related quality of life, and preoperative health status. Methods Patients receiving postoperative radiotherapy for breast cancer (OnkoFit I trial) or neoadjuvant, definitive, or postoperative treatment for other types of solid tumors (OnkoFit II trial) will be randomized (1:1:1) into 3-arm studies. Target accrual is 201 patients in each trial (50 patients per year). After providing informed consent, patients will be randomized into a standard care arm (arm A) or 1 of 2 interventional arms (arms B and C). Patients in arms B and C will wear an activity tracker and record their daily step count in a diary. Patients in arm C will receive personalized weekly targets for their physical activity. No further instructions will be given to patients in arm B. The target daily step goals for patients in arm C will be adjusted weekly and will be increased by 10% of the average daily step count of the past week until they reach a maximum of 6000 steps per day. Patients in arm A will not be provided with an activity tracker. The primary end point of the OnkoFit I trial is cancer-related fatigue at 3 months after the completion of radiotherapy. This will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. For the OnkoFit II trial, the primary end point is the overall quality of life, which will be assessed with the Functional Assessment of Cancer Therapy-General sum score at 6 months after treatment to allow for recovery after possible surgery. In parallel, blood samples from before, during, and after treatment will be collected in order to assess inflammatory markers. Results Recruitment for both trials started on August 1, 2020, and to date, 49 and 12 patients have been included in the OnkoFit I and OnkoFit II trials, respectively. Both trials were approved by the institutional review board prior to their initiation. Conclusions The OnkoFit trials test an innovative, personalized approach for the implementation of an activity tracker–guided training program for patients with cancer during radiotherapy. The program requires only a limited amount of resources. Trial Registration ClinicalTrials.gov NCT04506476; https://clinicaltrials.gov/ct2/show/NCT04506476. ClinicalTrials.gov NCT04517019; https://clinicaltrials.gov/ct2/show/NCT04517019. International Registered Report Identifier (IRRID) DERR1-10.2196/28524

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