Trials / Active Not Recruiting
Active Not RecruitingNCT05879133
HEALTH4CLL2: A Randomized Waitlist Control Trial of Behavioral Interventions in Patients With Chronic Lymphocytic Leukemia
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To learn if exercise and weight management can help to improve feelings of fatigue in CLL survivors.
Detailed description
Primary Objective: --Evaluate the impact of an organized, longitudinal, diet and exercise training program on fatigue as assessed by the Functional Assessment of Cancer Therapy (FACT) score in patients with CLL. Secondary Objectives: --Assess changes in physical activity, dietary behavior, physical function using the PROMIS physical function questionnaire and performance tests of physical function, body mass index (BMI) and global quality of life. Additionally, we will assess changes in fecal microbiome composition, metabolic parameters including a comprehensive lipid panel, glucose, insulin, TNF alpha, IL6, leptin, resistin, adiponectin, IGF1 and IGFBP1 and immunologic function as assessed by T cell and monocyte phenotypic and functional assays in patients with CLL after participation in the behavioral intervention. Exploratory Objectives: \-- Identify differences in the metabolic, immunologic and fecal microbiome composition in patients with CLL who have a high CLL comorbidity index score (CLL-CI) compared to patients with CLL and a low CLL-CI score. And, investigate the association of comorbidity score, disease features, CLL-specific prognostic factors and clinical outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Questionnaires | Survey |
| OTHER | Fit Bit | measures physical activity |
Timeline
- Start date
- 2023-05-17
- Primary completion
- 2027-07-03
- Completion
- 2027-07-03
- First posted
- 2023-05-30
- Last updated
- 2026-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05879133. Inclusion in this directory is not an endorsement.