Clinical trial NCT03609203: Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training
Official title: Improving Self-Efficacy and Resolving Inflammaging in Allogeneic Hematopoietic Cell Transplant Survivors Through Personalized Strength Programming: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allogeneic HCT Survivors
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A maximum of four pairs of patient/workout partners (8 subjects) should be actively participating in the 10-week group intervention on study at a time. Participants may sign consent at anytime but then begin group participation when spots become available.

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.


Eligibility 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

Primary outcomes:
measure: Self-reported outcomes of self-efficacy
timeFrame: Week 10
Secondary outcomes:
measure: Biomarkers of inflammaging in the blood
timeFrame: Week 10
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Division of Hematology, Oncology and Transplantation, University of Minnesota
name: Shernan G Holtan, MD
role: PRINCIPAL_INVESTIGATOR
References: