Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Test change | maximum distance walked in 6 minutes | from baseline to 30 days (+/- 10 days) after HCT |
| Measure | Description | Time Frame |
|---|---|---|
| Anabolic marker changes | IGF-1, GH, IGFBP-3, free and weakly bound testosterone | from baseline to 30 days (+/- 10 days) after HCT |
| Inflammatory marker changes | IL-6, CRP, TNF-alpha, and pre-albumin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Patients who for any reason elect not to participate.
Not provided
Not provided
Not provided
The study group will consist of 60 patients with hematologic malignancies treated with HCT
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
| from baseline to 30 days (+/- 10 days) after HCT |
| Muscle strength | handgrip strength; 1-RM | from baseline to 30 days (+/- 10 days) after HCT |
| resting energy expenditure changes | indirect calorimetry | from baseline to 30 days (+/- 10 days) after HCT |
| body composition changes | bio-impedance and dual-energy x-ray absorptiometry (all in kg) | from baseline to 30 days (+/- 10 days) after HCT |
| physical function changes | stair climbing power | from baseline to 30 days (+/- 10 days) after HCT |
| maximal oxygen consumption changes | VO2 max | from baseline to 30 days (+/- 10 days) after HCT |
| Quality of Life change score | ASAS | from baseline to 30 days (+/- 10 days) after HCT |
| Quality of Life change score | FACIT | from baseline to 30 days (+/- 10 days) after HCT |
| Quality of Life change score | Karnofsky | from baseline to 30 days (+/- 10 days) after HCT |
| Quality of Life change score | ECOG | from baseline to 30 days (+/- 10 days) after HCT |
| Food Frequency Questionnaire | from baseline to 30 days (+/- 10 days) after HCT |
| nutritional status | from baseline to 30 days (+/- 10 days) after HCT |
| use of nutrition support | from baseline to 30 days (+/- 10 days) after HCT |
| estimated nutritional requirements | from baseline to 30 days (+/- 10 days) after HCT |