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Researching the Effect of Exercise on Cancer

Primary Purpose

Breast Cancer, Prostate Cancer, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Prostate Cancer, Colorectal Cancer, exercise, ctDNA, 20-378, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • Natera, Inc. (Data or Specimen Analysis Only)
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose-Finding/Escalation

Dose Expansion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2020
Last Updated
September 15, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04589468
Brief Title
Researching the Effect of Exercise on Cancer
Official Title
Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
October 2, 2024 (Anticipated)
Study Completion Date
October 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Breast Cancer, Prostate Cancer, Colorectal Cancer, exercise, ctDNA, 20-378, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose-Finding/Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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+ 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Jones, PhD
Phone
646-888-8103
Email
jonesl3@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Diaz, MD
Phone
646-888-4204
Email
diazl5@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Natera, Inc. (Data or Specimen Analysis Only)
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shifra Krinshpun
Phone
510-826-3572
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103
First Name & Middle Initial & Last Name & Degree
Neil Iyengar, MD
Phone
646-888-4714
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Phone
646-888-8103

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Researching the Effect of Exercise on Cancer

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