A Study on the Effects of Exercise on Side Effects From Treatment for Rectal Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05789485

Collaborator

(none)

216

Enrollment

Locations

Arms

59.8

Anticipated Duration (Months)

30.9

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of Total Neoadjuvant Therapy (TNT). The study will also look at the way the body responds to exercise and whether there are differences in TNT treatment. This will include looking at the highest TNT treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of TNT.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Cancer	Behavioral: structured treadmill walking	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Patients and investigators will be blinded to results during study conduct.

Primary Purpose:

Treatment

Official Title:

Dose-response of Aerobic Training During Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Actual Study Start Date :

Mar 7, 2023

Anticipated Primary Completion Date :

Mar 1, 2028

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 90 min/wk AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during TNT. Supervised AT will be monitored using TeleEx.	Behavioral: structured treadmill walking Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from TNT initiation until surgery (~32 weeks).
Experimental: 150 mins/wk AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during TNT. Supervised AT will be monitored using TeleEx.	Behavioral: structured treadmill walking Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from TNT initiation until surgery (~32 weeks).
Experimental: 300 mins/wk AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during TNT. Supervised AT will be monitored using TeleEx.	Behavioral: structured treadmill walking Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from TNT initiation until surgery (~32 weeks).

Arm

Intervention/Treatment

Experimental: 90 min/wk

AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during TNT. Supervised AT will be monitored using TeleEx.

Behavioral: structured treadmill walking

Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered from TNT initiation until surgery (~32 weeks).

Experimental: 150 mins/wk

Behavioral: structured treadmill walking

Experimental: 300 mins/wk

Behavioral: structured treadmill walking

Outcome Measures

Primary Outcome Measures

proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90% [5 years]
RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged ≥18 years
Diagnosed with locally advanced rectal cancer as defined by one of the following:
Histological confirmation
As per standard of care imaging
Scheduled to receive TNT
Performing ≤90 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 the Physical Activity Readiness Questionnaire

Exclusion Criteria:

Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes
Receiving treatment for any other diagnosis of invasive cancer
Distant metastatic malignancy of any kind
Mental impairment leading to inability to cooperate
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	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Rockville Centre	New York	United States	11553

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Jessica Scott, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT05789485

Other Study ID Numbers:

22-164

First Posted:

Mar 29, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

Exercise

22-164

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Apr 3, 2023