A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors Post-treatment

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT07365007
Status
Recruiting
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Conditions

  • Chemotherapy-Induced Peripheral Neuropathy
  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Educational Intervention — OTHER
    Attend virtual general health education sessions
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Interview — OTHER
    Ancillary studies
  • Survey Administration — OTHER
    Ancillary studies

Study Details

This clinical trial studies whether a virtually delivered diet intervention focused on lower added sugar, higher fiber, and higher omega 3 fatty acid (LASO-3) can be used to improve chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors after treatment. Cancer survivors often experience CIPN during and after cancer treatment with neurotoxic chemotherapy. CIPN is characterized by nerve damage from chemotherapy that leads to numbness, tingling, or pain in the hands or feet. However, there are few treatments to manage CIPN. Inflammation contributes to the development of CIPN and dietary patterns that have been demonstrated to improve diet quality and reduce inflammation in cancer survivors may be promising for use as a CIPN management strategy. The LASO-3 diet intervention consists of virtually delivered nutrition education sessions provided by a Registered Dietitian. The sessions focus on three dietary goals, informed by the United States Dietary Guidelines for Americans: 1) lowering added sugar intake to \< 10% of daily calories, 2) increasing daily fiber intake to ≥ 20 grams, and 3) increasing intake of moderate-high omega-3 seafood to three or more servings weekly or 3300-3400 mg/day of alpha-linolenic acid (e.g., plant-based sources include canola or flaxseed oil, walnuts, or flaxseed or chia seeds). The Registered Dietitian tailors the sessions to the patient based on information and feedback obtained throughout the sessions. The LASO-3 diet intervention may be an effective way to improve CIPN in cancer survivors after treatment.

Key Dates

Start date
Feb 23, 2026
Status verified
Mar 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (LASO-3 sessions)
    Patients attend virtual LASO-3 nutrition counseling sessions over 30 minutes QW for 4 weeks followed by LASO-3 nutrition counseling sessions over 15 minutes Q2W for 8 weeks. Patients also undergo blood sample collection throughout the trial.
  • Active Comparator: Arm II (general health education sessions)
    Patients attend eight virtual general health education sessions over 15-30 minutes each over 12 weeks. Patients also undergo blood sample collection throughout the trial. Patients may also receive the intervention materials and up to 4 dietary counseling sessions post-study.

Primary Outcome Measure

Recruitment of all participants (Feasibility) [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Robert Knoerl
[email protected]
734-764-8617
Robert Knoerl (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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