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Trial Title:
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
NCT ID:
NCT05773144
Condition:
Colonic Neoplasms
Conditions: Official terms:
Colonic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Aerobic exercise
Description:
Moderate- to vigorous-intensity aerobic exercise
Arm group label:
150 min/wk aerobic exercise
Arm group label:
225 min/wk aerobic exercise
Arm group label:
300 min/wk aerobic exercise
Arm group label:
75 min/wk aerobic exercise
Intervention type:
Behavioral
Intervention name:
Progressive stretching
Description:
Static stretching of eight major muscle groups
Arm group label:
Attention control
Summary:
To goal of this clinical trial is to quantify the dose-response effects of aerobic
exercise training compared to attention control on chemotherapy relative dose intensity
in colon cancer survivors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥18 years
- Histologically confirmed stage II or III colon cancer
- Completed surgical resection with curative intent
- Plan to initiate chemotherapy
- Engage in <60 minutes per week of moderate- to vigorous-intensity structured aerobic
exercise
- No planned major surgery during the study period
- Readiness to exercise, as determined by a modified version of the Physical Activity
Readiness Questionnaire
- Can walk 400 meters
- Can read and speak English
- Ability to provide written informed consent
- Provide written approval by qualified healthcare professional
- Willing to be randomized
Exclusion Criteria:
- Evidence of metastatic colon cancer
- Concurrently actively treated other (non-colon) cancer
- Currently pregnant, breastfeeding, or planning to become pregnant within the next 24
weeks
- Currently participating in another study with competing outcomes
- Any other condition that, in the opinion of the investigator, would preclude
participation or successful compliance with the protocol
- Any other situation that, in the opinion of the investigator, would negatively
impact subject safety or successful compliance with the protocol
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaiser Permanente Northern California
Address:
City:
Oakland
Zip:
94612
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Michelle Ross
Email:
Michelle.C.Ross@kp.org
Investigator:
Last name:
Bette J Caan, Dr.P.H.
Email:
Principal Investigator
Facility:
Name:
Pennington Biomedical Research Center
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Brown
Email:
john.brown@pbrc.ed
Investigator:
Last name:
Justin C Brown, Ph.D.
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Amalia Perez
Email:
Amalia_PenaPerez@DFCI.HARVARD.EDU
Investigator:
Last name:
Jeffrey A Meyerhardt, M.D.
Email:
Principal Investigator
Start date:
June 1, 2023
Completion date:
May 2027
Lead sponsor:
Agency:
Pennington Biomedical Research Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Pennington Biomedical Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05773144
