Researching the Effect of Aerobic Exercise on Cancer

Cancer Clinical Trial

Official title:

Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996239
• Other study ID #: 19-126
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: June 2024

Study information

• Verified date: June 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

This study is being done to answer the following question: Will aerobic exercise (exercise that stimulates and strengthens the heart and lungs, and improves the body's use of oxygen) change the biomarkers (signs of disease) found in the blood?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Cohort 1: CH

• CH called by MSK practices as documented by an MSK physician

• Age =18 yrs

• Completion of all anticancer therapy

• High risk of cardiovascular disease defined by presence of at least one of the following:

• Age =60

• Prior treatment with chemotherapy

• Prior left-sided breast and/or chest wall radiotherapy

• Currently receiving or previously received androgen deprivation therapy Prior bone marrow transplant

• History of smoking

• Currently treated for one or more cardiovascular risk factors (i.e., hypertension, diabetes, hyperlipidemia)

• Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

• Willingness to comply with all study-related procedures

Cohort 2: Solid Tumor

• Patients at risk of harboring circulating tumor DNA as defined by one of the following:

• Histologically confirmed stage III (i.e., high risk of recurrence) colorectal cancer within 2 years of completion of all adjuvant therapy.

• Histologically confirmed stage III breast cancer with residual disease after neoadjuvant therapy and within 12 months of completing (neo)adjuvant chemotherapy

• Patients with metastatic breast cancer and radiographic stable disease or NED for =6 months and not currently receiving chemotherapy (endocrine therapy and anti-HER2 antibodies allowed)

• Age = 18 yrs

• Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

• Willingness to comply with all study-related procedures

Cohort 3: Active Surveillance

• Men with histologically confirmed localized prostate cancer undergoing active surveillance

• Age = 18 yrs

• Performing less than 15 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

• Willingness to comply with all study-related procedures

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

Cohort 4: Lynch Syndrome

• Age =18 yrs

• Hereditary colorectal cancer syndrome, specifically Lynch syndrome, defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes

• Have a portion of the distal colon or rectosigmoid intact to enable collection of normal mucosa biopsies

• Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

• Willingness to comply with all study-related procedures

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

Cohort 5: EDD Phase 0a

• Age =18 yrs

• Receiving investigational agent under an EDD protocol for at least 6 months.

• Stable disease or Partial Response per RECIST

• Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

• Willingness to comply with all study-related procedures

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

Phase 0b

• Age =18 yrs

• Newly Within 3 months of initiating investigational agent on an EDD Service protocol

• Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report

• Willingness to comply with all study-related procedures

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

Exclusion Criteria:

• Concurrent use of any form of antitumor therapy (endocrine therapy and anti-HER2 antibodies allowed)

• Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes (does not apply to Cohort 5: EDD)

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

• Mental impairment leading to inability to cooperate

• Any of the following contraindications to cardiopulmonary exercise testing (Cohorts 1 and 2 only):

1. Acute myocardial infarction within 3-5 days of any planned study procedures;

2. Unstable angina

3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise

4. Recurrent syncope

5. Active endocarditis

6. Acute myocarditis or pericarditis

7. Symptomatic severe aortic stenosis

8. Uncontrolled heart failure

9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures

10. Thrombosis of lower extremities within 3 months of any planned study procedures

11. Suspected dissecting aneurysm

12. Uncontrolled asthma

13. Pulmonary edema

14. Respiratory failure

15. Acute non-cardiopulmonary disorders that may affect exercise performance

• Room air desaturation at rest = 85% (Cohorts 1 and 2 only)

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• exercise (walking)
Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service

Other:
• plasma samples
Plasma samples will be obtained at baseline.
• blood draw
fasting blood

Locations

Country	Name	City	State
United States	SOMALOGIC (Data or Specimen Analysis Only)	Boulder	Colorado
United States	LABORATORY CORPORATION OF AMERICA HOLDINGS (Data or Specimen Analysis Only)	Burlington	North Carolina
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Duke University Medical Center (Data or Specimen Analysis Only)	Durham	North Carolina
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	University of California, Los Angeles (Data or Specimen Analysis Only)	Los Angeles	California
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	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	number of patients with variant allele frequency (VAF)	measured by targeted CH panel in peripheral blood	2 years
Primary	changes in residual tumor burden (Solid tumor group)	measured by the amount of circulating tumor DNA (ctDNA)	2 years

External Links

•   Memorial Sloan Kettering Cancer Center