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

Not Applicable

Completed

• Conditions: Resistance Training; Colon Cancer; Chemotherapy Effect
• Interventions: Behavioral: Resistance training

• Registration Number: NCT03291951
• Lead Sponsor: Kaiser Permanente

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2018-02-23
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance training group	Resistance training	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.

Primary Outcome Measures

Name	Time	Method
Relative dose intensity (RDI)	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	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.

Trial Locations

Locations (3)

Kaiser Permanente Division of Research; 🇺🇸 Oakland, California, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Penn State Cancer Institute; 🇺🇸 Hershey, Pennsylvania, United States