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NCT03291951: FORCE
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
NA trial testing Resistance training in Resistance Training in 183 participants. Completed in 21 March 2022.
21 March 2022
Quick facts
| Lead sponsor | Kaiser Permanente |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 183 |
| Start date | 23 February 2018 |
| Primary completion | 21 March 2022 |
| Estimated completion | 21 March 2022 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Resistance training
Conditions studied
- Resistance Training — all drugs for Resistance Training →
- Colon Cancer — all drugs for Colon Cancer →
- Chemotherapy Effect — all drugs for Chemotherapy Effect →
Sponsor
Kaiser Permanente — full company profile →
Who can join
18 and older, any sex, with Resistance Training or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The evolution of body composition in oncology-epidemiology, clinical trials, and the future of patient care: facts and numbers.
Brown JC, Cespedes Feliciano EM, Caan BJ. · · 2018 · cited 135× · PMID 30637983 · DOI 10.1002/jcsm.12379 -
Skeletal muscle mass loss and dose-limiting toxicities in metastatic colorectal cancer patients.
Kurk S, Peeters P, Stellato R, Dorresteijn B, et al · · 2019 · cited 85× · PMID 31094083 · DOI 10.1002/jcsm.12436 -
Effect of exercise on colorectal cancer prevention and treatment.
Oruç Z, Kaplan MA. · · 2019 · cited 72× · PMID 31139306 · DOI 10.4251/wjgo.v11.i5.348 -
Cancer- and Chemotherapy-Induced Musculoskeletal Degradation.
Sturgeon KM, Mathis KM, Rogers CJ, Schmitz KH, et al · · 2019 · cited 30× · PMID 30918923 · DOI 10.1002/jbm4.10187 -
Clinical implications of low skeletal muscle mass in early-stage breast and colorectal cancer.
Cespedes Feliciano E, Chen WY. · · 2018 · cited 29× · PMID 29860952 · DOI 10.1017/s0029665118000423 -
Muscle wasting in cancer: opportunities and challenges for exercise in clinical cancer trials.
Fairman CM, Lønbro S, Cardaci TD, VanderVeen BN, et al · · 2022 · cited 28× · PMID 36118249 · DOI 10.1002/rco2.56 -
Effect of home-based resistance training on chemotherapy relative dose intensity and tolerability in colon cancer: The FORCE randomized control trial.
Caan BJ, Brown JC, Brown JC, Lee C, et al · · 2024 · cited 12× · PMID 38265970 · DOI 10.1002/cncr.35204 -
Advances in Adherence Reporting of Resistance Training in a Clinical Trial during Adjuvant Chemotherapy for Colon Cancer.
Campbell KL, Brown JC, Lee C, Weltzien E, et al · · 2024 · cited 8× · PMID 38233992 · DOI 10.1249/mss.0000000000003395
Verify or expand the search:
- PubMed search for NCT03291951
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Resistance Training
Currently open trials in the same condition.
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Other Kaiser Permanente trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03291951 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kaiser Permanente
- Last refreshed: 28 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03291951.
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