VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
NCT Number: NCT02990130
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 study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Seattle, Washington, 98108, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: from baseline to 30 days (+/- 10 days) after HCT
maximum distance walked in 6 minutes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
IGF-1, GH, IGFBP-3, free and weakly bound testosterone
Time frame: from baseline to 30 days (+/- 10 days) after HCT
IL-6, CRP, TNF-alpha, and pre-albumin
Time frame: from baseline to 30 days (+/- 10 days) after HCT
handgrip strength; 1-RM
Time frame: from baseline to 30 days (+/- 10 days) after HCT
indirect calorimetry
Time frame: from baseline to 30 days (+/- 10 days) after HCT
bio-impedance and dual-energy x-ray absorptiometry (all in kg)
Time frame: from baseline to 30 days (+/- 10 days) after HCT
stair climbing power
Time frame: from baseline to 30 days (+/- 10 days) after HCT
VO2 max
Time frame: from baseline to 30 days (+/- 10 days) after HCT
ASAS
Time frame: from baseline to 30 days (+/- 10 days) after HCT
FACIT
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Karnofsky
Time frame: from baseline to 30 days (+/- 10 days) after HCT
ECOG
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Garcia, Jose M., MD, PhD
Indiv
Biochemical and Physiologic Factors That Affect Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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