Status:
COMPLETED
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Dana-Farber Cancer Institute
Penn State University
Conditions:
Resistance Training
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 diagn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT03291951
Start Date
February 23 2018
End Date
March 21 2022
Last Update
July 28 2022
Active Locations (3)
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1
Kaiser Permanente Division of Research
Oakland, California, United States, 94612
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033