Recruiting

Fatigue Mitigation

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06860880

Conditions

Indolent Lymphomas

Lymphoma

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Diet

Study Details

Brief summary:

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.

Conditions

Indolent Lymphomas

Lymphoma

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Follicular Lymphoma

Study ID

NCT06860880

Start date

Jun 3, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma

Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs.

Interventions

Exercise

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

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.

Primary outcome measure

  • The proportion of consented patients who are referred [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Devin McCarthy

(919)-445-4852devin_mccarthy@med.unc.edu

Locations

North Carolina Basnight Cancer Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Devin McCarthy

919-445-4852devin_mccarthy@med.unc.edu

Christopher E Jensen, MD

984-987-1072christopher.jensen@unchealth.unc.edu

Principal Investigator:

Christopher E Jensen, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • exercise
  • dietary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-07-01.