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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: Completed NA study of Colon Cancer and Resistance Training, sponsored by Kaiser Permanente.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT03291951 record still lists
NCT03291951 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 4,454-participant average among 97 other Colon Cancer trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03291951's enrollment target sits among peer trials
183 38th of 97 higher than 60 of 97 other Colon Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colon Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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