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Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors

NCT ID: NCT07365007Sponsor: University of Michigan Rogel Cancer CenterLast updated: 2026-03-03

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.

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

  • OtherEducational Intervention

    Attend virtual general health education sessions

  • OtherElectronic Health Record Review

    Ancillary studies

  • OtherInterview

    Ancillary studies

  • OtherSurvey Administration

    Ancillary studies

Outcome measures

Primary

  • 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 24 weeks

Secondary

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

    Time frame: At 12 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109

Recruiting
Robert Knoerl · Contact
734-764-8617rjknoerl@med.umich.edu
Robert Knoerl · Principal Investigator
A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors Post-treatment | Cancerify