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Resistance TrainingFORCENCT03291951

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

A study testing Resistance training in people with Resistance Training and Colon Cancer, run by Kaiser Permanente at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 diagnosed Stage II and III colon cancer patients from Kaiser Permanente of Northern California (KPNC), the Penn State Cancer… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
3 sitesUnited States
Study dates
23 Feb 2018to 21 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

  • Kaiser Permanente Division of Research

    Oakland, California, 94612

Other trials in United States

About this study

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.

Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance trainingBehavioural

    The intervention goal is for study participants to exercise with progressively higher weights for resistance training to achieve a 1-kg increase in lean body mass by the end of the intervention. During an in-person visit on the same day as a chemotherapy infusion session, exercise professionals will teach participants a series of exercises to be completed at home twice weekly throughout the intervention. Participants will also receive protein powder, which they will be instructed to consume with meals twice a day. During subsequent infusion sessions, the exercise professional will meet in-person with participants to evaluate their ability to increase weights, and adjust exercises appropriately. In between visits, the exercise professional will check-in with participants by phone.

Study groups in NCT03291951
Study groupRoleWhat they receive
Resistance training groupExperimentalParticipants 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.
Receives: Behavioral: Resistance training
Usual care groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative dose intensity (RDI)

    Chemotherapy completion rates will be assessed as relative dose intensity for each agent and then average relative dose intensity (ARDI), which considers all chemotherapy agents in a regimen. We will examine differences in RDI for each chemotherapy agent and the ARDI across all agents between the RT group and the UC group.

    Measured: 3-6 months

  2. Number of moderate and severe chemotherapy-associated toxicities

    Moderate and severe chemotherapy-associated toxicities will be assessed via a NCI PRO-CTCAE questionnaire, which is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start23 Feb 2018
  3. Primary completion21 Mar 2022
  4. Study completion21 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This randomized controlled trial of resistance training intervention in colon cancer patients receiving chemotherapy consists of two arms: an in-person and telephone-based intervention to promote home-based resistance training, and a wait-list, control group.
Masking
None (open label)
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03291951
Sponsor's protocol ID
CN-17-2877
Acronym
FORCE
Status last verified
Jul 2022
First submitted
7 Sep 2017
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee 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.

    PubMed 40278841

  • Compton 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.

    PubMed 39369275

  • Brown 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.

    PubMed 39012500

Questions about this trial

What is this clinical trial studying?

A study testing Resistance training in people with Resistance Training and Colon Cancer, run by Kaiser Permanente at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative dose intensity (RDI) (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03291951, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.

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