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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04824443
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Covid19 Coronavirus Cancer Other: Aerobic Exercise Therapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Therapy in Cancer Patients Hospitalized for COVID-19: A Digitized Clinical Trial
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : March 29, 2023
Estimated Study Completion Date : March 29, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants who were hospitalized for COVID-19
Participants will be post-cancer treatment patients who were hospitalized for COVID-19.
 Other: Aerobic Exercise Therapy
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).
Other Name: AT


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of serious adverse events during study-related assessments [ Time Frame: 30 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824443


Contacts
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Contact: Jessica Scott, PhD 646-888-8093 scottj1@mskcc.org
Contact: Lee Jones, PhD 646-888-8103 jonesl3@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Jessica Scott, PhD    646-888-8093      
Memoral Sloan Kettering Monmouth (Limited protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Jessica Scott, PhD    646-888-8093      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Jessica Scott, PhD    646-888-8093      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Jessica Scott, PhD    646-888-8093      
Memoral Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Jessica Scott, PhD    646-888-8093      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Jessica Scott, PhD    646-888-8093      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Jessica Scott, PhD    646-888-8093      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jessica Scott, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04824443    
Other Study ID Numbers: 21-101
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Covid19
Coronavirus
Cancer
 Exercise
21-101
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases