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NCT Number: NCT07365007

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

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Robert Knoerl

CONTACT

[email protected]

734-764-8617

Robert Knoerl

PRINCIPAL_INVESTIGATOR

About this study

02MAY2026- Amendment was approved to update inflammatory disease exclusion criteria.

28MAY2026- Amendment was approved to clarifying the eligibility to exclude individuals who have preexisting peripheral neuropathy (instead of neuropathy overall as this is not specific and could include centralized pain).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 peripheral 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
  • High grade inflammatory disease such as lupus, Crohn's disease, or rheumatoid arthritis
  • 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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Educational Intervention

Other

Attend virtual general health education sessions

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Electronic Health Record Review

Other

Ancillary studies

interview

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Recruitment of all participants (Feasibility)

    Time frame: Up to 2 years

    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).

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

    Time frame: At baseline and 12 weeks

    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.

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

    Time frame: Up to 12 weeks

    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.

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

    Time frame: Up to 24 weeks

    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.

Secondary outcomes

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

    Time frame: At 12 weeks

    Will determine the LASO-3 diet group participants' perspectives of acceptability and satisfaction with the twelve-week intervention using semi-structured interviews. Semi-structured interviews will be professionally transcribed and analyzed using inductive content analysis. Transcripts will be uploaded to NVivo (QSR International), where Dr. Knoerl and the research team will independently derive codes, collaboratively group them into categories, and identify key themes with representative quotations.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Hope Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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