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

University of Michigan Rogel Cancer Center

Status: Not yet enrolling

Conditions: Hematopoietic and Lymphatic System Neoplasm; Chemotherapy-Induced Peripheral Neuropathy; Malignant Solid Neoplasm

Treatments: Other: Educational Intervention; Procedure: Biospecimen Collection; Other: Survey Administration; Other: Electronic Health Record Review; Other: Interview

Study type: Interventional

Funder types: Other

Identifiers

NCT07365007

NCI-2025-07988 (Registry Identifier)

UMCC 2025.077

HUM00274541 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• At least three months since last receiving neurotoxic chemotherapy
• Self-report moderate (≥ 2/4) numbness and tingling on the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE™) Numbness and Tingling Severity Item in the last week
• Speak/read English
• Have access to the internet

Exclusion criteria

• Pre-existing neuropathy from any cause
• Plan to begin a new prescription of duloxetine (i.e., first-line treatment for CIPN pain) during the study period
• Are enrolled in symptom management trials that may alter CIPN severity
• Current inflammatory disease
• Routine nonsteroidal anti-inflammatory drug (NSAID) or steroid supplementation
• Consuming an average three or more servings of fish per week and/or consuming fish oil capsules containing eicosapentaenoic acid (EPA)+ docosahexaenoic acid (DHA) daily or consuming flax oil capsules daily
• Consuming an average of less than 5 servings of sweets, candy bars, chocolate, doughnuts, cookies, cakes, pie, brownies, ice cream, pastries, or sugar sweetened beverages (e.g., soda or coffee/tea) per week

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm I (LASO-3 sessions)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Survey Administration

Other: Electronic Health Record Review

Procedure: Biospecimen Collection

Arm II (general health education sessions)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Electronic Health Record Review

Procedure: Biospecimen Collection

Other: Educational Intervention