Clinical trial NCT04824443: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Covid19
Coronavirus
Cancer
Keywords: Covid19
Coronavirus
Cancer
Exercise
21-101
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Frequency of serious adverse events during study-related assessments
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jessica Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References: