Skip to content

Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation

Biochemical and Physiologic Factors That Affect Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation for Hematologic Malignancies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02990130
Enrollment
60
Registered
2016-12-13
Start date
2016-11-30
Completion date
2025-07-31
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancy

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.

Detailed description

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 investigators hypothesize that: 1) HCT for hematologic malignancies is associated with a change in biochemical and physiologic factors that reflect patient fitness and 2) Baseline (pre-HCT) and post-HCT changes of biochemical and physiologic factors that reflect patient fitness are associated with HCT-related clinical outcomes.This is a pilot study involving patients enrolled in the Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy. No vulnerable population will be included. 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. Data collection may include: 1. Blood tests other than those performed as clinical standard of care may include: anabolic and catabolic factors such as IGF-1, GH, IGFBP-3, free and weakly bound testosterone, IL-6, CRP, TNF-alpha, and pre-albumin. 2. Measurements of fitness other than those obtained as clinical standard of care may include: resting energy expenditure (REE) assessed by indirect calorimetry; body composition measured by bio-impedance (BIA) and dual-energy x-ray absorptiometry (DEXA) scan; handgrip strength; stair climbing power; 6-minute walk test; muscle strength; maximal oxygen consumption (VO2 max); and previously validated questionnaires to assess patient quality of life (QOL) and functional status. 3. Additional data that may be collected for this protocol will include clinical and laboratory data acquired per standard of clinical care as pertains to subjects' co-morbidities, hematologic disease and treatment history, and clinical course including nutritional status, use of nutrition support, and estimated nutritional requirements per routine dietitian assessments. A Food Frequency Questionnaire will be administered by a dietitian in addition to the routine clinical assessments. The primary endpoint of this study is the change over time of patient fitness as assessed by the 6 minute walk test through HCT. Secondary endpoints will include other markers of anabolism and catabolism, and data collected as mentioned above.

Interventions

OTHERObservational

Sponsors

Garcia, Jose M., MD, PhD
Lead SponsorINDIV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

• Patients who for any reason elect not to participate.

Design outcomes

Primary

MeasureTime frameDescription
6-Minute Walk Test changefrom baseline to 30 days (+/- 10 days) after HCTmaximum distance walked in 6 minutes

Secondary

MeasureTime frameDescription
Inflammatory marker changesfrom baseline to 30 days (+/- 10 days) after HCTIL-6, CRP, TNF-alpha, and pre-albumin
Muscle strengthfrom baseline to 30 days (+/- 10 days) after HCThandgrip strength; 1-RM
resting energy expenditure changesfrom baseline to 30 days (+/- 10 days) after HCTindirect calorimetry
body composition changesfrom baseline to 30 days (+/- 10 days) after HCTbio-impedance and dual-energy x-ray absorptiometry (all in kg)
physical function changesfrom baseline to 30 days (+/- 10 days) after HCTstair climbing power
Anabolic marker changesfrom baseline to 30 days (+/- 10 days) after HCTIGF-1, GH, IGFBP-3, free and weakly bound testosterone
Quality of Life change scorefrom baseline to 30 days (+/- 10 days) after HCTASAS
Food Frequency Questionnairefrom baseline to 30 days (+/- 10 days) after HCT
nutritional statusfrom baseline to 30 days (+/- 10 days) after HCT
use of nutrition supportfrom baseline to 30 days (+/- 10 days) after HCT
estimated nutritional requirementsfrom baseline to 30 days (+/- 10 days) after HCT
maximal oxygen consumption changesfrom baseline to 30 days (+/- 10 days) after HCTVO2 max

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026