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.
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
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:
- 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.
- Conditions
- Hematologic Malignancy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test change
maximum distance walked in 6 minutes
Measured: from baseline to 30 days (+/- 10 days) after HCT
Secondary outcomes (15)
Anabolic marker changes
IGF-1, GH, IGFBP-3, free and weakly bound testosterone
Measured: from baseline to 30 days (+/- 10 days) after HCT
Inflammatory marker changes
IL-6, CRP, TNF-alpha, and pre-albumin
Measured: from baseline to 30 days (+/- 10 days) after HCT
Muscle strength
handgrip strength; 1-RM
Measured: from baseline to 30 days (+/- 10 days) after HCT
resting energy expenditure changes
indirect calorimetry
Measured: from baseline to 30 days (+/- 10 days) after HCT
body composition changes
bio-impedance and dual-energy x-ray absorptiometry (all in kg)
Measured: from baseline to 30 days (+/- 10 days) after HCT
physical function changes
stair climbing power
Measured: from baseline to 30 days (+/- 10 days) after HCT
maximal oxygen consumption changes
VO2 max
Measured: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
ASAS
Measured: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
FACIT
Measured: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
Karnofsky
Measured: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
ECOG
Measured: from baseline to 30 days (+/- 10 days) after HCT
Food Frequency Questionnaire
Measured: from baseline to 30 days (+/- 10 days) after HCT
nutritional status
Measured: from baseline to 30 days (+/- 10 days) after HCT
use of nutrition support
Measured: from baseline to 30 days (+/- 10 days) after HCT
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.
- First posted13 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2022
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Garcia, Jose M., MD, PhD
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical and Physiologic Factors That Affect Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02990130
- Acronym / sponsor ID
- 00935
- Conditions
- Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Garcia, Jose M., MD, PhD
- Study start
- Nov 2016
- Primary completion
- Dec 2022 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: ObservationalThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will consist of 60 patients with hematologic malignancies treated with HCT
Key inclusion criteria (3 listed)
- Histologically confirmed hematologic malignancy.
- Undergoing evaluation at the BMTU at the Puget Sound VA.
- Planning or receiving an autologous or allogeneic HCT
Key exclusion criteria (1 listed)
- Patients who for any reason elect not to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational | Other | Study Group |
Primary outcome
6-Minute Walk Test change
Time frame: from baseline to 30 days (+/- 10 days) after HCT
maximum distance walked in 6 minutes
15 secondary outcomes
Anabolic marker changes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Inflammatory marker changes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Muscle strength
Time frame: from baseline to 30 days (+/- 10 days) after HCT
resting energy expenditure changes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
body composition changes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
physical function changes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
maximal oxygen consumption changes
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Quality of Life change score
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Food Frequency Questionnaire
Time frame: from baseline to 30 days (+/- 10 days) after HCT
nutritional status
Time frame: from baseline to 30 days (+/- 10 days) after HCT
use of nutrition support
Time frame: from baseline to 30 days (+/- 10 days) after HCT
estimated nutritional requirements
Time frame: from baseline to 30 days (+/- 10 days) after HCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.