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

NCT07365007 | Recruiting DMC

• 3 other identifiers: UMCC 2025.077NCI-2025-07988HUM00274541
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Recruitment of all participants (Feasibility)

  Feasibility will be established if the following benchmark is met, recruitment of all participants within a two-year period (Demand). The observed recruitment rate will be estimated along with exact 80% confidence intervals (CIs).

  Up to 2 years

• Completion of baseline and 12-week patient-reported outcome measures (Feasibility)

  Feasibility will be established if the following benchmark is met, ≥ 60% completion of baseline and 12-week patient-reported outcome measures. The observed retention rate will be estimated along with exact 80% CIs.

  At baseline and 12 weeks

• Percent of LASO-3 participants who attend at least 5 out of 8 intervention sessions (Feasibility)

  Feasibility will be established if the following benchmark is met, ≥ 60% of LASO-3 participants attend at least 5 out of 8 intervention sessions (Implementation). The observed retention rate will be estimated along with exact 80% CIs.

  Up to 12 weeks

• Percent of LASO-3 participants who self-report adherence to dietary goals (Feasibility)

  Feasibility will be established if the following benchmark is met, ≥ 60% of LASO-3 participants self-report adherence to dietary goals via VioScreen food frequency questionnaire and/or monthly adherence checklists (Practicality). The observed adherence rate will be estimated along with exact 80% CIs.

  Up to 24 weeks

Secondary Outcomes (1)

• Acceptability and satisfaction with the twelve-week LASO-3 diet intervention

  At 12 weeks

Study Arms (2)

Arm I (LASO-3 sessions)

EXPERIMENTAL

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.

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

Arm II (general health education sessions)

ACTIVE COMPARATOR

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (LASO-3 sessions); Arm II (general health education sessions)

Educational Intervention OTHER

Attend virtual general health education sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (general health education sessions)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (LASO-3 sessions); Arm II (general health education sessions)

Interview OTHER

Ancillary studies

Arm I (LASO-3 sessions)

Survey Administration OTHER

Ancillary studies

Arm I (LASO-3 sessions); Arm II (general health education sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• The Hope Foundation: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling; Early Intervention, Educational; Educational Status; Methods; Interviews as Topic

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert Knoerl

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)