Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/16/2018
Start Date:November 2016
End Date:July 2020
Contact:Jose M Garcia, MD, PhD
Email:jose.garcia@va.gov
Phone:206-764-2984

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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.

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.

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.
We found this trial at
1
site
1660 South Columbian Way
Seattle, Washington 98108
(206) 762-1010
Phone: 206-764-2984
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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