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
Conditions the study is for: Resistance Training, Colon Cancer, Chemotherapy Effect
What is being tested?: Resistance training
Type of treatment: Injection or infusion, Lifestyle or therapy programme
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

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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.

Conditions: Resistance Training, Colon Cancer, Chemotherapy Effect
Being tested: Resistance training
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 group	Role	What they receive
Resistance training group	Experimental	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. Receives: Behavioral: Resistance training
Usual care group	No intervention	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.

What is being measured

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

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
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.

23 Feb 201821 Mar 2022

First posted25 Sep 2017
Study start23 Feb 2018
Primary completion21 Mar 2022
Study completion21 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Resistance TrainingStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
ClinicalTrials.gov ID: NCT03291951
Acronym / sponsor ID: FORCE / CN-17-2877
Conditions: Resistance Training, Colon Cancer, Chemotherapy Effect
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: Dana-Farber Cancer Institute, Penn State University
Study start: 23 Feb 2018 (actual)
Primary completion: 21 Mar 2022 (actual)
Study completion: 21 Mar 2022 (actual)
First posted: 25 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

FORCE is a randomized home-based resistance training/strength training (RT) intervention study for Stage II and III colon cancer patients undergoing chemotherapy.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Resistance training group	Experimental	Behavioral: Resistance trainingParticipants 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.
Usual care group	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Resistance trainingThe 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.	Behavioural	Resistance training group

Primary outcome

Relative dose intensity (RDI)
Time frame: 3-6 months
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.
Number of moderate and severe chemotherapy-associated toxicities
Time frame: 3-6 months
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.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
Derived from this study: PubMed 40278841Lee 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.
Derived from this study: PubMed 39369275Compton 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.
Derived from this study: PubMed 39012500Brown 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bette J Caan, DrPH principal investigator

Kaiser Permanente

Kathryn H Schmitz, PhD, MPH principal investigator

Penn State Cancer Institute

Jeffrey Meyerhardt, MD, MPH principal investigator

Dana-Farber Cancer Institute

3 sites in 1 country: see every site and its status.

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.