Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation

NCT02990130 | Active Not Recruiting

• 1 other identifier: 00935
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal aims to characterize biochemical and physiologic factors that contribute to changes in patient fitness and body composition during hematopoietic stem cell transplantation (HCT) for hematologic malignancies. The study group will consist of 60 patients with hematologic malignancies treated with HCT. Measurements of patient fitness, body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested periodically for up to 2 years after HCT.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walk Test change

  maximum distance walked in 6 minutes

  from baseline to 30 days (+/- 10 days) after HCT

Secondary Outcomes (15)

• Anabolic marker changes

  from baseline to 30 days (+/- 10 days) after HCT

• Inflammatory marker changes

  from baseline to 30 days (+/- 10 days) after HCT

• Muscle strength

  from baseline to 30 days (+/- 10 days) after HCT

• resting energy expenditure changes

  from baseline to 30 days (+/- 10 days) after HCT

• body composition changes

  from baseline to 30 days (+/- 10 days) after HCT

Study Arms (1)

Study Group

This is a pilot observational study involving patients enrolled in the Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy. Measurements of patient fitness, body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested periodically for up to 2 years after HCT.

Other: Observational

Interventions

Observational OTHER

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study group will consist of 60 patients with hematologic malignancies treated with HCT

You may qualify if:

• Histologically confirmed hematologic malignancy.
• Undergoing evaluation at the BMTU at the Puget Sound VA.
• Planning or receiving an autologous or allogeneic HCT

You may not qualify if:

• Patients who for any reason elect not to participate.

Sponsors & Collaborators

• Garcia, Jose M., MD, PhD: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 13, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)