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NCT03291951 · ClinicalTrials.gov registry record · NA
FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study
A NA study of Colon Cancer and Resistance Training, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 183
- Enrollment target
- 3
- Study locations
NCT03291951 is a NA study of Colon Cancer and Resistance Training that has completed, run by Kaiser Permanente. The registered enrollment target is 183 participants, below the 4,454-participant average among 97 other Colon Cancer trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03291951, a NA study of Colon Cancer and Resistance Training, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 183 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Resistance training
Study Locations (3)
California
- Kaiser Permanente Division of Research - Oakland
Massachusetts
- Dana Farber Cancer Institute - Boston
Pennsylvania
- Penn State Cancer Institute - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2018-02-23 |
| Est. Completion | 2022-03-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03291951
The ClinicalTrials.gov registry entry for NCT03291951 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,454-participant average among 97 other Colon Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Colon Cancer appearing as the primary indexed condition, and to 1 intervention - of which Resistance training is the first listed.
NCT03291951 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Massachusetts, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03291951 about?
NCT03291951 is a clinical study titled "FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise 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), th...
What is the current status of trial NCT03291951?
This trial is currently completed. It is a NA study. The enrollment target is 183 participants. The study started on 2018-02-23. Estimated completion is 2022-03-21.
What conditions does trial NCT03291951 study?
This clinical trial studies the following conditions: Colon Cancer, Resistance Training, Chemotherapy Effect.
What interventions are being tested in trial NCT03291951?
The interventions under investigation include: Resistance training (BEHAVIORAL).
Who is sponsoring clinical trial NCT03291951?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03291951 being conducted?
This trial has 3 study locations across California, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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