What this study is
This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.
What's being tested
- Exercise
Intervention · OTHER
Each patient will receive an individualized exercise prescription that will encompass both aerobic and resistance training, with modifications as necessary to accommodate each patient's needs, abilities, and medical condition. For those not participating in any formal exercise at baseline, the exercise prescription will consist of a basic conditioning program targeting 150 minutes of moderate physical activity weekly with the assistance of a physical therapist if deemed appropriate.
- Diet
Intervention · OTHER
Participants will undergo nutritional consultations with a registered dietitian who specializes in oncology. The dietitian will provide tailored dietary recommendations using evidence-based nutrition guidelines. Participants will also be screened ffor ormal nutrition based on American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines as indicated.
Study details
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Indolent Lymphomas · Lymphoma · Chronic Lymphocytic Leukemia · Small Lymphocytic Lymphoma · Follicular Lymphoma · Marginal Zone Lymphoma · Lymphoplasmacytic Lymphoma · Waldenstrom Macroglobulinemia · Cutaneous T Cell Lymphoma
- Enrolling
- 40 people
- Starts
- 2025-06-03
- Est. completion
- 2026-12-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.
- Significant symptoms of fatigue, as defined by PROMIS Fatigue score >50.
You can't join if
- Other co-existing malignancies.
- Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.
- Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia/thrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.
- Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorth Carolina Basnight Cancer Hospital
Chapel Hill, North Carolina, United States
- Devin McCarthy · Contact919-445-4852devin_mccarthy@med.unc.edu
- Christopher E Jensen, MD · Contact984-987-1072 ext. Jensenchristopher.jensen@unchealth.unc.edu
- Christopher E Jensen, MD · Principal investigator
Recruiting
Study team
Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID LCCC2403
Principal investigator
Christopher Jensen, MD MSCR
UNC Lineberger Comprehensive Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.