Researching the Effect of Exercise on Cancer

Conditions

• Breast Cancer
• Colorectal Cancer
• Prostate Cancer
• Stage I Breast Cancer
• Stage I Colorectal Cancer
• Stage I Prostate Cancer
• Stage II Breast Cancer
• Stage II Colorectal Cancer
• Stage II Prostate Cancer
• Stage III Breast Cancer
• Stage III Colorectal Cancer
• Stage III Prostate Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Exercise — OTHER
  Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial.

Study Details

Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.

Key Dates

First listed

Oct 19, 2020

Start date

Oct 30, 2026

Status verified

Aug 2026

Primary completion

Feb 13, 2028

Completion

Feb 13, 2028

Study Design

Enrollment

51 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Dose-Finding/Escalation
  Fifty (n=50) post-treatment patients with colorectal cancer or breast cancer, deemed high-risk of relapse. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial.
• Experimental: Dose Expansion
  An independent cohort of 30 post-treatment patients with colorectal (n=15) or breast (n=15) cancer deemed high-risk of relapse. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D.

Primary Outcome Measure

Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b. [ Time Frame: 24 weeks ]

Central Contacts

• Lee Jones, MD
  6262184673
  [email protected]

Locations (9)

Find similar trials in Durate, CA

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