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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Other: Observational

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minute Walk Test change	maximum distance walked in 6 minutes	from baseline to 30 days (+/- 10 days) after HCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anabolic marker changes	IGF-1, GH, IGFBP-3, free and weakly bound testosterone	from baseline to 30 days (+/- 10 days) after HCT
Inflammatory marker changes	IL-6, CRP, TNF-alpha, and pre-albumin	from baseline to 30 days (+/- 10 days) after HCT
Muscle strength	handgrip strength; 1-RM	from baseline to 30 days (+/- 10 days) after HCT
resting energy expenditure changes	indirect calorimetry	from baseline to 30 days (+/- 10 days) after HCT
body composition changes	bio-impedance and dual-energy x-ray absorptiometry (all in kg)	from baseline to 30 days (+/- 10 days) after HCT
physical function changes	stair climbing power	from baseline to 30 days (+/- 10 days) after HCT
maximal oxygen consumption changes	VO2 max	from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score	ASAS	from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score	FACIT	from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score	Karnofsky	from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score	ECOG	from baseline to 30 days (+/- 10 days) after HCT
Food Frequency Questionnaire		from baseline to 30 days (+/- 10 days) after HCT
nutritional status		from baseline to 30 days (+/- 10 days) after HCT
use of nutrition support		from baseline to 30 days (+/- 10 days) after HCT
estimated nutritional requirements		from baseline to 30 days (+/- 10 days) after HCT

Collaborators and Investigators

• Sponsor: Garcia, Jose M., MD, PhD

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 00935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO