Allogeneic HCT Survivors
Conditions
Brief summary
This protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls.
Interventions
OTHER10 Weeks of Strength Trailing
Week 1 (pre training session): self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples
OTHERGroup Nutrition Discussion: week 1, week 5 and week 10
Week 1 (pre training session): self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteers: must be the friends or relatives of the cancer patients enrolled in this study. Inclusion Criteria: * HCT recipients * Age ≥ 18 years * Greater than 6 months after completing systemic multiagent chemotherapy (greater than 12 months for HCT participants) at the time of enrollment. Maintenance chemotherapy is allowed * In remission from cancer Off immunosuppression, or on a stable immunosuppression regimen with prednisone doses ≤ 20 mg daily, with no changes planned to the immunosuppression regimen during the study period * Karnofsky performance status ≥ 50% (Appendix III) * Platelet count ≥ 50,000 without transfusions * Absolute neutrophil count ≥ 1 * Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw) * Currently reside within the Minneapolis-St. Paul metro area * Has an adult (age ≥ 18) friend or relative who is willing to serve as an exercise partner and healthy control for the study * If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment * Willing and able to sign voluntary written consent * Healthy Controls * Age ≥ 18 years * Karnofsky performance status ≥ 50% * Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw) * Currently reside within the Minneapolis-St. Paul metro area * If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment * Willing and able to sign voluntary written consent
Exclusion criteria
for both Cancer Survivors and Controls * Presence of an external central venous catheter (Hickman, PICC, etc); Port-a-cath devices that are completely internal are allowed * Use of ≥ 20+ mg prednisone daily * Current or planned use of investigational drugs during the study period * Myocardial infarction or stroke within 6 months * Heart failure graded Class IV on New York Heart Association (NYHA) scale (https://manual.jointcommission.org/releases/TJC2018A/DataElem0439.html) * Any medical condition that the consenting medical provider deems would make the participant unsafe to perform a 10-week strength training program * Are currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported outcomes of self-efficacy | Week 10 | To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of inflammaging in the blood | Week 10 | To evaluate changes in biomarkers of inflammaging in the blood of HCT recipients before and after the intervention compared to controls. |
Countries
United States
Outcome results
None listed