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Hematologic MalignancyNCT02990130

Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation

An observational study of Hematologic Malignancy, run by Garcia, Jose M., MD, PhD at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Malignancy
What is being tested?
Observational
How many people
60 participants
Where
1 siteUnited States
Study dates
Nov 2016to Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study group will consist of 60 patients with hematologic malignancies treated with HCT

Who may be able to join

  • Histologically confirmed hematologic malignancy.
  • Undergoing evaluation at the BMTU at the Puget Sound VA.
  • Planning or receiving an autologous or allogeneic HCT

Who cannot join

  • Patients who for any reason elect not to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Observational
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

Study groups in NCT02990130
Study groupRoleWhat they receive
Study GroupThis 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.
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-Minute Walk Test change

    maximum distance walked in 6 minutes

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

Secondary outcomes (15)
  1. Anabolic marker changes

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

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

  2. Inflammatory marker changes

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

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

  3. Muscle strength

    handgrip strength; 1-RM

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

  4. resting energy expenditure changes

    indirect calorimetry

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

  5. body composition changes

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

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

  6. physical function changes

    stair climbing power

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

  7. maximal oxygen consumption changes

    VO2 max

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

  8. Quality of Life change score

    ASAS

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

  9. Quality of Life change score

    FACIT

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

  10. Quality of Life change score

    Karnofsky

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

  11. Quality of Life change score

    ECOG

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

  12. Food Frequency Questionnaire

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

  13. nutritional status

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

  14. use of nutrition support

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

  15. estimated nutritional requirements

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2022
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02990130
Sponsor's protocol ID
00935
Status last verified
Sep 2024
First submitted
2 Dec 2016
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Malignancy, run by Garcia, Jose M., MD, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Minute Walk Test change (time frame: from baseline to 30 days (+/- 10 days) after HCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.

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