Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02990130
• Other study ID #: 00935
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: Garcia, Jose M., MD, PhD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• Observational

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Garcia, Jose M., MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

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