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.
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
60
VA Puget Sound Health Care System
Seattle, Washington, United States
6-Minute Walk Test change
maximum distance walked in 6 minutes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Anabolic marker changes
IGF-1, GH, IGFBP-3, free and weakly bound testosterone
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Inflammatory marker changes
IL-6, CRP, TNF-alpha, and pre-albumin
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Muscle strength
handgrip strength; 1-RM
Time frame: from baseline to 30 days (+/- 10 days) after HCT
resting energy expenditure changes
indirect calorimetry
Time frame: from baseline to 30 days (+/- 10 days) after HCT
body composition changes
bio-impedance and dual-energy x-ray absorptiometry (all in kg)
Time frame: from baseline to 30 days (+/- 10 days) after HCT
physical function changes
stair climbing power
Time frame: from baseline to 30 days (+/- 10 days) after HCT
maximal oxygen consumption changes
VO2 max
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
ASAS
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
FACIT
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
Karnofsky
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
ECOG
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Food Frequency Questionnaire
Time frame: from baseline to 30 days (+/- 10 days) after HCT
nutritional status
Time frame: from baseline to 30 days (+/- 10 days) after HCT
use of nutrition support
Time frame: from baseline to 30 days (+/- 10 days) after HCT
estimated nutritional requirements
Time frame: from baseline to 30 days (+/- 10 days) after HCT
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