Clinical trial · Interventional
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Resistance Training | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resistance training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Resistance training group
- description
- 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.
- interventionNames
- Behavioral: Resistance training
- type
- NO_INTERVENTION
- label
- Usual care group
- description
- 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.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDLee S, Ma C, Caan BJ, Binder AM, Brown JC, Pena Perez A, Lee C, Weltzien E, Ross MC, Quesenberry CP, Campbell KL, Cespedes Feliciano EM, Castillo A, Schmitz KH, Meyerhardt JA. Impact of resistance training on inflammatory biomarkers and associations with treatment outcomes in colon cancer. Cancer. 2025 May 1;131(9):e35865. doi: 10.1002/cncr.35865. PMID 40278841
- DERIVEDCompton SLE, Yang S, Madere J, Weltzien EK, Caan BJ, Meyerhardt JA, Schmitz KH, Brown JC. Dietary quality and chemotherapy-induced peripheral neuropathy in colon cancer. Cancer. 2025 Jan 1;131(1):e35599. doi: 10.1002/cncr.35599. Epub 2024 Oct 5. PMID 39369275
- DERIVEDBrown JC, Yang S, Compton SLE, Campbell KL, Cespedes Feliciano EM, Quinney S, Sternfeld B, Caan BJ, Meyerhardt JA, Schmitz KH. Effect of resistance training on physical function during chemotherapy in colon cancer. JNCI Cancer Spectr. 2024 Jul 1;8(4):pkae058. doi: 10.1093/jncics/pkae058. PMID 39012500