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NCT Number: NCT02990130

Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

Primary outcomes

  1. 6-Minute Walk Test change

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    maximum distance walked in 6 minutes

Secondary outcomes

  1. Anabolic marker changes

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    IGF-1, GH, IGFBP-3, free and weakly bound testosterone

  2. Inflammatory marker changes

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    IL-6, CRP, TNF-alpha, and pre-albumin

  3. Muscle strength

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    handgrip strength; 1-RM

  4. resting energy expenditure changes

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    indirect calorimetry

  5. body composition changes

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    bio-impedance and dual-energy x-ray absorptiometry (all in kg)

  6. physical function changes

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    stair climbing power

  7. maximal oxygen consumption changes

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    VO2 max

  8. Quality of Life change score

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    ASAS

  9. Quality of Life change score

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    FACIT

  10. Quality of Life change score

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    Karnofsky

  11. Quality of Life change score

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

    ECOG

  12. Food Frequency Questionnaire

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

  13. nutritional status

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

  14. use of nutrition support

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

  15. estimated nutritional requirements

    Time frame: from baseline to 30 days (+/- 10 days) after HCT

Sponsors and collaborators

Lead sponsor

Garcia, Jose M., MD, PhD

Indiv

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2025
First posted
Dec 13, 2016
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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