FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/23/2018 |
| Start Date: | February 16, 2018 |
| End Date: | May 2022 |
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.
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.
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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