Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Colonic Neoplasms Clinical Trial

— ACTION  

Official title:

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773144
• Other study ID #: PBRC 2022-018
• Secondary ID: U01CA271279
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Pennington Biomedical Research Center
• Contact: Justin C. Brown, Ph.D.
• Phone: 225-763-2715
• Email: justin.brown[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 219
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Behavioral:
• Aerobic exercise
Moderate- to vigorous-intensity aerobic exercise
• Progressive stretching
Static stretching of eight major muscle groups

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemotherapy Relative Dose Intensity	The ratio of the delivered dose intensity to the standard or planned dose intensity.	12- or 24-weeks