NCT05773144

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jun 2023May 2027

First Submitted

Initial submission to the registry

March 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

March 6, 2023

Last Update Submit

January 5, 2026

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Chemotherapy Relative Dose Intensity

    The ratio of the delivered dose intensity to the standard or planned dose intensity.

    12- or 24-weeks

Study Arms (5)

Attention control

SHAM COMPARATOR

Static stretching

Behavioral: Progressive stretching

75 min/wk aerobic exercise

EXPERIMENTAL

Aerobic exercise at a dose of 75 minutes per week

Behavioral: Aerobic exercise

150 min/wk aerobic exercise

EXPERIMENTAL

Aerobic exercise at a dose of 150 minutes per week

Behavioral: Aerobic exercise

225 min/wk aerobic exercise

EXPERIMENTAL

Aerobic exercise at a dose of 225 minutes per week

Behavioral: Aerobic exercise

300 min/wk aerobic exercise

EXPERIMENTAL

Aerobic exercise at a dose of 300 minutes per week

Behavioral: Aerobic exercise

Interventions

Aerobic exerciseBEHAVIORAL

Moderate- to vigorous-intensity aerobic exercise

150 min/wk aerobic exercise225 min/wk aerobic exercise300 min/wk aerobic exercise75 min/wk aerobic exercise
Progressive stretchingBEHAVIORAL

Static stretching of eight major muscle groups

Attention control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

RECRUITING

AdventHealth

Orlando, Florida, 32804, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Justin C. Brown, Ph.D.

    AdventHealth

    PRINCIPAL INVESTIGATOR

  • Jeffrey A. Meyerhardt, M.D., M.P.H.

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Bette J. Caan, Dr.P.H.

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin C. Brown, Ph.D.

CONTACT

4076095000Justin.Brown4@AdventHealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Investigator

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 17, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

US(3)