Colon Cancer Clinical Trial
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Men and women ≥18 years
Newly diagnosed with histologically confirmed stage II-Ill colon cancer
Completed curative-intent surgical resection
Currently prescribed one of the following adjuvant chemotherapy regimens: (IV 5-fluorouracil [5-FU] / leucovorin [LV], capecitabine, FOLFOX [5-FU, LV, oxaliplatin], CAPOX [capecitabine and oxaliplatin]
Patients must have started chemotherapy or plan to start with receipt of the first exercise visit by 3rd infusion visit. Patients enrolled at the Dana-Farber Cancer Institute and who are receiving FOLFOX chemotherapy are eligible to enroll in the pharmacokinetics sub-study.
No planned major surgery anticipated in the intervention period
Sufficient time to heal from any major surgery to start of intervention, including colostomy reversal (port-a-cath removal excluded)
Approval by either oncologist or surgeon to participate in trial
Readiness as determined by the Physical Activity Readiness Questionnaire
Ability to understand and the willingness to sign a written informed consent document in English
Willingness to be randomized
Exclusion Criteria:
Concurrent actively treated other cancer (except non-melanoma skin cancer, in situ cervical cancer or localized prostate cancer treated with surveillance only)
Patients with untreated hypertension (>180 mm Hg systolic or >100 mm Hg diastolic) appearing in the patient's medical record in the two weeks prior to screening
Presence of metastatic disease
Current strength training >2x week for the past 3 or more months
Patients enrolled in other clinical trials of weight loss, physical activity or dietary interventions are ineligible.
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There are 3 Locations for this study
Oakland California, 94612, United States
Boston Massachusetts, 02215, United States
Hershey Pennsylvania, 17033, United States
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