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

Primary Purpose

Resistance Training, Colon Cancer, Chemotherapy Effect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance training
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Resistance Training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente Division of Research
  • Dana Farber Cancer Institute
  • Penn State Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance training group

Usual care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2017
Last Updated
July 27, 2022
Sponsor
Kaiser Permanente
Collaborators
Dana-Farber Cancer Institute, Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT03291951
Brief Title
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Acronym
FORCE
Official Title
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Dana-Farber Cancer Institute, Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistance Training, Colon Cancer, Chemotherapy Effect

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative dose intensity (RDI)
Description
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.
Time Frame
3-6 months
Title
Number of moderate and severe chemotherapy-associated toxicities
Description
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.
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bette J Caan, DrPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn H Schmitz, PhD, MPH
Organizational Affiliation
Penn State Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Meyerhardt, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Penn State Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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