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Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer (ACTION)

Primary Purpose

Colonic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Progressive stretching
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years Histologically confirmed stage II or III colon cancer Completed surgical resection with curative intent Plan to initiate an oxaliplatin-based chemotherapy regimen 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

Sites / Locations

  • Kaiser Permanente Northern California
  • Pennington Biomedical Research CenterRecruiting
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Attention control

75 min/wk aerobic exercise

150 min/wk aerobic exercise

225 min/wk aerobic exercise

300 min/wk aerobic exercise

Arm Description

Static stretching

Aerobic exercise at a dose of 75 minutes per week

Aerobic exercise at a dose of 150 minutes per week

Aerobic exercise at a dose of 225 minutes per week

Aerobic exercise at a dose of 300 minutes per week

Outcomes

Primary Outcome Measures

Chemotherapy Relative Dose Intensity
The ratio of the delivered dose intensity to the standard or planned dose intensity.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2023
Last Updated
May 5, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05773144
Brief Title
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Acronym
ACTION
Official Title
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
219 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention control
Arm Type
Sham Comparator
Arm Description
Static stretching
Arm Title
75 min/wk aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise at a dose of 75 minutes per week
Arm Title
150 min/wk aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise at a dose of 150 minutes per week
Arm Title
225 min/wk aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise at a dose of 225 minutes per week
Arm Title
300 min/wk aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise at a dose of 300 minutes per week
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Moderate- to vigorous-intensity aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Progressive stretching
Intervention Description
Static stretching of eight major muscle groups
Primary Outcome Measure Information:
Title
Chemotherapy Relative Dose Intensity
Description
The ratio of the delivered dose intensity to the standard or planned dose intensity.
Time Frame
12- or 24-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Histologically confirmed stage II or III colon cancer Completed surgical resection with curative intent Plan to initiate an oxaliplatin-based chemotherapy regimen 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin C. Brown, Ph.D.
Phone
225-763-2715
Email
justin.brown@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin C. Brown, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Meyerhardt, M.D., M.P.H.
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bette J. Caan, Dr.P.H.
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Ross
Email
Michelle.C.Ross@kp.org
First Name & Middle Initial & Last Name & Degree
Bette J Caan, Dr.P.H.
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Brown
Email
john.brown@pbrc.ed
First Name & Middle Initial & Last Name & Degree
Justin C Brown, Ph.D.
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amalia Perez
Email
Amalia_PenaPerez@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Jeffrey A Meyerhardt, M.D.

12. IPD Sharing Statement

Learn more about this trial

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

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