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NCT03291951: FORCE

FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study

Completed NA Last updated 28 July 2022
What this trial tests

NA trial testing Resistance training in Resistance Training in 183 participants. Completed in 21 March 2022.

Timeline
23 February 2018
Primary endpoint
21 March 2022
21 March 2022

Quick facts

Lead sponsorKaiser Permanente
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment183
Start date23 February 2018
Primary completion21 March 2022
Estimated completion21 March 2022
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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

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