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Exercise Therapy in Cancer Patients Who Are Recovering From COVID-19

Primary Purpose

Covid19, Coronavirus, Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise Therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Covid19, Coronavirus, Cancer, Exercise, 21-101, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18
  • Previously admitted to a hospital for Covid-19
  • Discharged from hospital for at least 30 days
  • Previously treated for cancer at MSK
  • Interval of ≥ 12 months but ≤ 10 years following completion of primary non-hormonal anti-cancer therapy (current endocrine therapy and maintenance therapy allowed)
  • Space to house a treadmill at personal residence
  • Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+)
  • Performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self-report

  • If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.

    • Women <50 years old who are of child-bearing potential must have a negative pregnancy test within 14 days of enrollment.

Exclusion Criteria:

  • Currently receiving home oxygen after discharge
  • Enrollment onto any other interventional investigational study
  • Current treatment for any other diagnosis of invasive cancer of any kind
  • Distant metastatic malignancy of any kind
  • Receiving non-hormonal anticancer therapy
  • Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  • Memorial Sloan Kettering Monmouth (Limited protocol activities)
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants who were hospitalized for COVID-19

Arm Description

Participants will be post-cancer treatment patients who were hospitalized for COVID-19.

Outcomes

Primary Outcome Measures

Frequency of serious adverse events during study-related assessments
Safety will be evaluated by the frequency of serious (i.e., life-threatening, hospitalization, significant incapacity, important medical events) adverse events during study-related assessments and exercise sessions according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
May 2, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04824443
Brief Title
Exercise Therapy in Cancer Patients Who Are Recovering From COVID-19
Official Title
Exercise Therapy in Cancer Patients Hospitalized for COVID-19: A Digitized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
March 29, 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
The purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic exercise therapy program in cancer patients recovering from COVID-19. The study will look at whether the aerobic exercise therapy causes few or mild side effects in participants. Aerobic exercise is physical activity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for several minutes at a time. The aerobic exercise therapy being used in this study will be a walking program that will be adjusted so it matches participant fitness levels (how much exercise you can handle).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Coronavirus, Cancer
Keywords
Covid19, Coronavirus, Cancer, Exercise, 21-101, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants who were hospitalized for COVID-19
Arm Type
Experimental
Arm Description
Participants will be post-cancer treatment patients who were hospitalized for COVID-19.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Therapy
Other Intervention Name(s)
AT
Intervention Description
Aerobic Exercise Therapy/AT will consist of 30 weeks of treadmill walking sessions. AT will consist of supervised, individualized walking delivered up to 6 times weekly (over a 7-day period) to achieve a cumulative total duration ranging from 90 mins/wk up to 375 mins/wk following a non-linear dosing schedule. The planned dose and scheduling of AT will be continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period (i.e., non-linear periodized schedule).
Primary Outcome Measure Information:
Title
Frequency of serious adverse events during study-related assessments
Description
Safety will be evaluated by the frequency of serious (i.e., life-threatening, hospitalization, significant incapacity, important medical events) adverse events during study-related assessments and exercise sessions according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Previously admitted to a hospital for Covid-19 Discharged from hospital for at least 30 days Previously treated for cancer at MSK Interval of ≥ 12 months but ≤ 10 years following completion of primary non-hormonal anti-cancer therapy (current endocrine therapy and maintenance therapy allowed) Space to house a treadmill at personal residence Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) Performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self-report If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study. Women <50 years old who are of child-bearing potential must have a negative pregnancy test within 14 days of enrollment. Exclusion Criteria: Currently receiving home oxygen after discharge Enrollment onto any other interventional investigational study Current treatment for any other diagnosis of invasive cancer of any kind Distant metastatic malignancy of any kind Receiving non-hormonal anticancer therapy Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Limited protocol activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

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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Exercise Therapy in Cancer Patients Who Are Recovering From COVID-19

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