Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients

Abramson Cancer Center at Penn Medicine1 site in 1 country72 target enrollmentFebruary 15, 2023

ConditionsAllogeneic Transplantation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Allogeneic Transplantation
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 72
Locations: 1
Primary Endpoint: Median number of exercise sessions delivered pre-HCT and post-HCT.
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing allogeneic HCT. The primary objective is to determine feasibility. Up to 60-72 evaluable subjects will be enrolled. Evaluable subjects are defined as those participating in the exercise intervention.

Registry

clinicaltrials.gov

Start Date

February 15, 2023

End Date

June 1, 2031

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Cohort A (Prehab)
•Age 60 years or older.
•Planned allogeneic HCT in the next 1-6 months.
•Hematological malignancy as the indication for HCT.
•Pre-frail or frail by Fried frailty phenotype.
•Cohort B (Rehab)
•Age 60 years or older.
•Planned allogeneic HCT or HCT within the last 30 days.
•Hematological malignancy as the indication for HCT.

Exclusion Criteria

•Cohorts A and B
•1\. Comorbid disability or illness that prevents safe exercise.

Outcomes

Primary Outcomes

Median number of exercise sessions delivered pre-HCT and post-HCT.

Time Frame: From 3 months prior to HCT to 100 days after HCT

Proportion of enrolled subjects who participate in the supervised exercise program

Time Frame: From 3 months prior to HCT to 100 days after HCT

Secondary Outcomes

1-year and 2-year PFS(From day 0 of HCT to 1-year and 2-years)
Hospital LOS for HCT(From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months)
Rate of readmission(From time of discharge from initial hospital stay up through 1-2 years after HCT)
6-month and 1-year overall mortality(From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS)
1-year and 2-year OS(From day 0 of HCT to 1-year and 2-years)