Researching the Effect of Exercise on Cancer

Breast Cancer Clinical Trial

Official title:

Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589468
• Other study ID #: 20-378
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: October 2, 2024

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Lee Jones, PhD
• Phone: 646-888-8103
• Email: jonesl3[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2, 2024
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postsurgical diagnosis of high-risk colorectal cancer or high-risk breast cancer as defined by one of the following:

° High-risk colorectal cancer

• Stage 3 or

• ctDNA positive

° High-risk breast cancer

• Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),

• Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,

• CPS-EG score = 3,

• CPS-EG score =2 w ith ypN+, or

• Recurrence score = 25

• No evidence of disease

• Age = 18

• Interval of = 1 month but = 2 years following completion of all definitive adjuvant therapy

• Non-exercising (i.e., < 30 minutes of moderate and < 20 mins of vigorous exercise/wk), as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry)

° If = 30 minutes but less than 45 minutes of moderate exercise/week, or if = 20 minutes but less than 30 minutes of vigorous exercise/week, patients may be eligible, at the discretion of the PI.

• Cleared for exercise participation as per screening clearance via PAR-Q+

• Willingness to comply with all study-related procedures

Exclusion Criteria:

• Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes

• Any other current diagnosis of invasive cancer of any kind

• Distant metastatic malignancy of any kind

• Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• 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

Intervention

Other:
• Exercise
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Natera, Inc. (Data or Specimen Analysis Only)	San Carlos	California
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.	Using an adaptive phase 1 (non-randomized) design, non-exercising (i.e., <60 mins/wk of moderate or vigorous exercise) post-treatment patients with primary breast, prostate, or colorectal cancer and detectable ctDNA (n=50) will be administered one of five escalating dose levels.	24 weeks

External Links

•   Memorial Sloan Kettering Cancer Center