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Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT02990130
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Garcia, Jose M., MD, PhD

Brief 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.

Condition or disease Intervention/treatment
Hematologic Malignancy Other: Observational

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biochemical and Physiologic Factors That Affect Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
Study Start Date : November 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023

Group/Cohort Intervention/treatment
Study Group
This is a pilot observational study involving patients enrolled in the Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy. 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.
Other: Observational



Primary Outcome Measures :
  1. 6-Minute Walk Test change [ Time Frame: from baseline to 30 days (+/- 10 days) after HCT ]
    maximum distance walked in 6 minutes


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study group will consist of 60 patients with hematologic malignancies treated with HCT
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990130


Contacts
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Contact: Jose M Garcia, MD, PhD 206-764-2984 jose.garcia@va.gov
Contact: Lindsey J Anderson, PhD 206-277-6719 lindsey.anderson5@va.gov

Locations
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United States, Washington
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Jose M Garcia, MD, PhD    206-764-2984 ext 72984    jose.garcia@va.gov   
Sponsors and Collaborators
Garcia, Jose M., MD, PhD
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Responsible Party: Garcia, Jose M., MD, PhD
ClinicalTrials.gov Identifier: NCT02990130    
Other Study ID Numbers: 00935
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases