FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study (FORCE)
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|ClinicalTrials.gov Identifier: NCT03291951|
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2017
Last Update Posted : December 21, 2018
FORCE is a randomized home-based resistance training/strength training (RT) intervention study for Stage II and III colon cancer patients undergoing chemotherapy.
Participants will be 180 newly diagnosed Stage II and III colon cancer patients from Kaiser Permanente of Northern California (KPNC), the Penn State Cancer Institute (PSCI), and the Dana Farber Cancer Institute (DFCI). The intervention will begin within the first weeks of adjuvant chemotherapy and continue exercise through the completion of post-operative chemotherapy. Specifically, the investigators will examine between group differences for RT versus waitlist control for chemotherapy outcomes including dose delays, dose reductions, early stoppage and Grade 3 and 4 toxicities. The investigators will also study changes in muscle mass (MM) and changes in specific inflammatory markers (e.g. CRP, IL-6 and TNF-RII) as potential markers of change in response to RT. To determine effects of change of MM on chemotherapy-specific drug clearance, the investigators will examine the impact body composition changes on the pharmacokinetics (PK) of 5-FU and oxaliplatin, two of the most commonly used drugs for colon cancer.
|Condition or disease||Intervention/treatment||Phase|
|Resistance Training Colon Cancer Chemotherapy Effect||Behavioral: Resistance training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This randomized controlled trial of resistance training intervention in colon cancer patients receiving chemotherapy consists of two arms: an in-person and telephone-based intervention to promote home-based resistance training, and a wait-list, control group.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study|
|Actual Study Start Date :||February 16, 2018|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Resistance training group
Participants randomized to the resistance training (RT) group will receive an in-person and telephone-based intervention to promote home-based resistance training. The exercise intervention will begin by the 3rd adjuvant chemotherapy visit and continue exercise through the completion of post-operative chemotherapy. Participants will work with an exercise professional with expertise working with oncology patients.
Behavioral: Resistance training
The intervention goal is for study participants to exercise with progressively higher weights for resistance training to achieve a 1-kg increase in lean body mass by the end of the intervention. During an in-person visit on the same day as a chemotherapy infusion session, exercise professionals will teach participants a series of exercises to be completed at home twice weekly throughout the intervention. Participants will also receive protein powder, which they will be instructed to consume with meals twice a day. During subsequent infusion sessions, the exercise professional will meet in-person with participants to evaluate their ability to increase weights, and adjust exercises appropriately. In between visits, the exercise professional will check-in with participants by phone.
No Intervention: Usual care group
Participants randomized to the usual care (U) group will be instructed to refer to their physician regarding what forms of exercise are safe for them, given their medical history. The U group will be told to continue whatever exercise program they have been undertaking up to enrolling in the study, but not to increase exercise or begin weight-lifting over the period of study participation.
- Dose reductions [ Time Frame: 3-6 months ]At the initiation of adjuvant chemotherapy, the investigators will ascertain planned cumulative dose for participants.The investigators will examine electronic medical records for reductions in chemotherapy doses throughout treatment.
- Dose delays [ Time Frame: 3-6 months ]At the initiation of adjuvant chemotherapy, the investigators will ascertain planned treatment duration for participants.The investigators will then examine electronic medical records for changes in chemotherapy timing such as dose delays.
- Early discontinuation of treatment [ Time Frame: 3-6 months ]At the initiation of adjuvant chemotherapy, the investigators will ascertain planned treatment duration for participants.The investigators will then examine electronic medical records for early discontinuation of treatment.
- Treatment-related toxicity- absolute neutrophil and platelet counts [ Time Frame: 3-6 months ]Moderate and severe chemotherapy-associated toxicities will be assessed via medical record review of absolute neutrophil and platelet counts.
- Treatment-related toxicity- NCI PRO-CTCAE [ Time Frame: 3-6 months ]Moderate and severe chemotherapy-associated toxicities will be assessed via a NCI PRO-CTCAE questionnaire, which is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.
- Treatment-related toxicity- Patient-completed side effects questionnaire [ Time Frame: 3-6 months ]At baseline and follow-up, moderate and severe chemotherapy-associated toxicities will be assessed via a patient-completed side effects questionnaire, which asks participants to report on symptoms or problems related to neuropathy that they have experienced in the past week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291951
|United States, California|
|Kaiser Permanente Division of Research|
|Oakland, California, United States, 94612|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Pennsylvania|
|Penn State Cancer Institute|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Bette J Caan, DrPH||Kaiser Permanente|
|Principal Investigator:||Kathryn H Schmitz, PhD, MPH||Penn State Cancer Institute|
|Principal Investigator:||Jeffrey Meyerhardt, MD, MPH||Dana-Farber Cancer Institute|