Researching the Effect of Exercise on Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04589468

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

8.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Prostate Cancer Colorectal Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer Stage I Colorectal Cancer Stage II Colorectal Cancer Stage III Colorectal Cancer	Other: Exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 2, 2020

Anticipated Primary Completion Date :

Oct 2, 2024

Anticipated Study Completion Date :

Oct 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

Other: Exercise

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 as per standard imaging
Age ≥ 18
Interval of ≥ 1 month but ≤ 1 year following completion of all definitive adjuvant therapy
Non-exercising (i.e., < 30 mins 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)
Cleared for exercise participation as per screening clearance via PAR-Q+

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Natera, Inc. (Data or Specimen Analysis Only)	San Carlos	California	United States	94070
2	Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
3	Memoral Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey	United States	07748
4	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
5	Memorial Sloan Kettering Commack (Limited Protocol Activities)	Commack	New York	United States	11725
6	Memoral Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
7	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
8	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York	United States	11553