Colonic NeoplasmsACTIONNCT05773144
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
A study testing Aerobic exercise and Progressive stretching in people with Colonic Neoplasms, run by AdventHealth Translational Research Institute at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Aerobic exercise and Progressive stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christine Lu, M.P.H., christine_lu@dfci.harvard.edu
Jeffrey A Meyerhardt, M.D.
- Recruiting
Kaiser Permanente Northern California
Oakland, California, 94612
Michelle Ross, Michelle.C.Ross@kp.org
Bette J Caan, Dr.P.H.
- Recruiting
AdventHealth
Orlando, Florida, 32804
Abigail Tice, Ph.D., Abigail.Tice@AdventHealth.com
Justin Brown, Ph.D.
About this study
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.
- Conditions
- Colonic Neoplasms
- Being tested
- Aerobic exercise, Progressive stretching
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Moderate- to vigorous-intensity aerobic exercise
Progressive stretchingBehavioural
Static stretching of eight major muscle groups
| Study group | Role | What they receive |
|---|---|---|
| Attention control | Sham comparator | Static stretching Receives: Behavioral: Progressive stretching |
| 75 min/wk aerobic exercise | Experimental | Aerobic exercise at a dose of 75 minutes per week Receives: Behavioral: Aerobic exercise |
| 150 min/wk aerobic exercise | Experimental | Aerobic exercise at a dose of 150 minutes per week Receives: Behavioral: Aerobic exercise |
| 225 min/wk aerobic exercise | Experimental | Aerobic exercise at a dose of 225 minutes per week Receives: Behavioral: Aerobic exercise |
| 300 min/wk aerobic exercise | Experimental | Aerobic exercise at a dose of 300 minutes per week Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Relative Dose Intensity
The ratio of the delivered dose intensity to the standard or planned dose intensity.
Measured: 12- or 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jun 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Justin Brown, AdventHealth Translational Research Institute
- Investigators
- Justin C. Brown, Ph.D., Principal investigator, AdventHealthJeffrey A. Meyerhardt, M.D., M.P.H., Principal investigator, Dana-Farber Cancer InstituteBette J. Caan, Dr.P.H., Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773144
- Sponsor's protocol ID
- PBRC 2022-018
- Other IDs
- U01CA271279
- Acronym
- ACTION
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
- ClinicalTrials.gov ID
- NCT05773144
- Acronym / sponsor ID
- ACTION / PBRC 2022-018
- Conditions
- Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Attention control | Sham comparator | Behavioral: Progressive stretchingStatic stretching |
| 75 min/wk aerobic exercise | Experimental | Behavioral: Aerobic exerciseAerobic exercise at a dose of 75 minutes per week |
| 150 min/wk aerobic exercise | Experimental | Behavioral: Aerobic exerciseAerobic exercise at a dose of 150 minutes per week |
| 225 min/wk aerobic exercise | Experimental | Behavioral: Aerobic exerciseAerobic exercise at a dose of 225 minutes per week |
| 300 min/wk aerobic exercise | Experimental | Behavioral: Aerobic exerciseAerobic exercise at a dose of 300 minutes per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseModerate- to vigorous-intensity aerobic exercise | Behavioural | 150 min/wk aerobic exercise, 225 min/wk aerobic exercise, 300 min/wk aerobic exercise, 75 min/wk aerobic exercise |
| Progressive stretchingStatic stretching of eight major muscle groups | Behavioural | Attention control |
Primary outcome
Chemotherapy Relative Dose Intensity
Time frame: 12- or 24-weeks
The ratio of the delivered dose intensity to the standard or planned dose intensity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin C. Brown, Ph.D. principal investigator
AdventHealth
Jeffrey A. Meyerhardt, M.D., M.P.H. principal investigator
Dana-Farber Cancer Institute
Bette J. Caan, Dr.P.H. principal investigator
Kaiser Permanente
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Progressive stretching in people with Colonic Neoplasms, run by AdventHealth Translational Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin C. Brown, Ph.D. (4076095000, Justin.Brown4@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy Relative Dose Intensity (time frame: 12- or 24-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.