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

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ClinicalTrials.gov Identifier: NCT03291951
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2017
Last Update Posted : December 21, 2018
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Penn State University
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Resistance Training Colon Cancer Chemotherapy Effect Behavioral: Resistance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resistance training group
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.
Behavioral: Resistance training
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.

No Intervention: Usual care group
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.



Primary Outcome Measures :
  1. Dose reductions [ Time Frame: 3-6 months ]
    At the initiation of adjuvant chemotherapy, the investigators will ascertain planned cumulative dose for participants.The investigators will examine electronic medical records for reductions in chemotherapy doses throughout treatment.

  2. Dose delays [ Time Frame: 3-6 months ]
    At the initiation of adjuvant chemotherapy, the investigators will ascertain planned treatment duration for participants.The investigators will then examine electronic medical records for changes in chemotherapy timing such as dose delays.

  3. Early discontinuation of treatment [ Time Frame: 3-6 months ]
    At the initiation of adjuvant chemotherapy, the investigators will ascertain planned treatment duration for participants.The investigators will then examine electronic medical records for early discontinuation of treatment.

  4. Treatment-related toxicity- absolute neutrophil and platelet counts [ Time Frame: 3-6 months ]
    Moderate and severe chemotherapy-associated toxicities will be assessed via medical record review of absolute neutrophil and platelet counts.

  5. Treatment-related toxicity- NCI PRO-CTCAE [ 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.

  6. Treatment-related toxicity- Patient-completed side effects questionnaire [ Time Frame: 3-6 months ]
    At baseline and follow-up, moderate and severe chemotherapy-associated toxicities will be assessed via a patient-completed side effects questionnaire, which asks participants to report on symptoms or problems related to neuropathy that they have experienced in the past week.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291951


Locations
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United States, California
Kaiser Permanente Division of Research
Oakland, California, United States, 94612
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Kaiser Permanente
Dana-Farber Cancer Institute
Penn State University
Investigators
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Principal Investigator: Bette J Caan, DrPH Kaiser Permanente
Principal Investigator: Kathryn H Schmitz, PhD, MPH Penn State Cancer Institute
Principal Investigator: Jeffrey Meyerhardt, MD, MPH Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Kaiser Permanente:
Study Protocol  [PDF] August 17, 2017


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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03291951     History of Changes
Other Study ID Numbers: CN-17-2877
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases