Clinical trial NCT03291951: FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Official title: FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Training
Colon Cancer
Chemotherapy Effect
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Penn State University
First posted: 2017-09-25
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relative dose intensity (RDI)
timeFrame: 3-6 months
measure: Number of moderate and severe chemotherapy-associated toxicities
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Kaiser Permanente
name: Bette J Caan, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Cancer Institute
name: Kathryn H Schmitz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Jeffrey Meyerhardt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: