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Aerobic Exercise During Chemotherapy for Colorectal Cancer (ACTION Trial)
N/A
Recruiting
Led By Jeffrey A. Meyerhardt, M.D., M.P.H.
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12- or 24-weeks
Awards & highlights
ACTION Trial Summary
This trial will measure how exercise affects cancer survivors' chemotherapy treatment and its effectiveness.
Who is the study for?
This trial is for adults over 18 with stage II or III colon cancer who've had surgery to remove it and are about to start chemo. They should exercise less than an hour a week, be able to walk 400 meters, understand English, and be ready to exercise as per a questionnaire.Check my eligibility
What is being tested?
The study measures how different amounts of aerobic exercise affect the body's response to chemotherapy in colon cancer survivors compared to those doing just stretching exercises.See study design
What are the potential side effects?
While not drug-related, potential side effects from aerobic exercise may include muscle soreness, fatigue, and increased risk of injury if not done properly.
ACTION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12- or 24-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12- or 24-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chemotherapy Relative Dose Intensity
ACTION Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: 75 min/wk aerobic exerciseExperimental Treatment1 Intervention
Aerobic exercise at a dose of 75 minutes per week
Group II: 300 min/wk aerobic exerciseExperimental Treatment1 Intervention
Aerobic exercise at a dose of 300 minutes per week
Group III: 225 min/wk aerobic exerciseExperimental Treatment1 Intervention
Aerobic exercise at a dose of 225 minutes per week
Group IV: 150 min/wk aerobic exerciseExperimental Treatment1 Intervention
Aerobic exercise at a dose of 150 minutes per week
Group V: Attention controlPlacebo Group1 Intervention
Static stretching
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic exercise
2000
Completed Phase 2
~1130
Find a Location
Who is running the clinical trial?
Pennington Biomedical Research CenterLead Sponsor
305 Previous Clinical Trials
181,817 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,635 Total Patients Enrolled
Jeffrey A. Meyerhardt, M.D., M.P.H.Principal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am starting treatment with oxaliplatin-based chemotherapy.I do not have any major surgeries planned during the study.My colon cancer has spread to other parts of my body.I am 18 years old or older.I can walk 400 meters without assistance.My colon cancer is confirmed to be at stage II or III.I had surgery to remove my cancer with the goal of curing it.
Research Study Groups:
This trial has the following groups:- Group 1: Attention control
- Group 2: 150 min/wk aerobic exercise
- Group 3: 75 min/wk aerobic exercise
- Group 4: 300 min/wk aerobic exercise
- Group 5: 225 min/wk aerobic exercise
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for enrolment in this clinical investigation?
"Affirmative. Clinical trials.gov lists this clinical trial as being open for recruitment, having been first posted on May 1st 2023 and last updated on May 5th of the same year. A total of 219 patients are sought from 3 distinct sites."
Answered by AI
How many participants have been recruited for this clinical investigation?
"Affirmative. According to the clinicaltrials.gov listing, this study is open for enrollment and has been since May 1st 2023 with its last update on May 5th 2023. 219 participants are needed between 3 different healthcare facilities."
Answered by AI
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