Virtual LASO-3 diet program to ease chemotherapy-related numbness and tingling
Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors
This trial tests whether a virtual diet program that lowers added sugar and increases fiber and omega-3s can help cancer survivors who have numbness, tingling, or pain after neurotoxic chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07365007 on ClinicalTrials.gov |
What this trial studies
This interventional study delivers the LASO-3 diet program virtually through nutrition education sessions led by a Registered Dietitian, with goals of lower added sugar, higher fiber, and increased omega-3 intake based on U.S. Dietary Guidelines. Participants are cancer survivors at least three months after their last neurotoxic chemotherapy who report at least moderate numbness and tingling and can participate in English-language online sessions. The study collects surveys, interviews, biospecimens, and electronic health record data to measure changes in chemotherapy-induced peripheral neuropathy symptoms and related biomarkers. Individuals with pre-existing neuropathy, routine anti-inflammatory drug or steroid use, or high baseline fish/omega-3 intake are excluded to isolate the diet effect.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adult cancer survivors at least three months after neurotoxic chemotherapy who report moderate or worse numbness and tingling and have internet access for virtual sessions.
Not a fit: Patients with pre-existing non-chemotherapy neuropathy, active inflammatory disease, routine NSAID/steroid use, or already high fish/omega-3 intake are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the diet program could reduce neuropathy symptoms and improve daily function and quality of life for cancer survivors with CIPN.
How similar studies have performed: Dietary patterns that reduce inflammation and increased omega-3 intake have shown promise for symptom reduction in related contexts, but using a targeted virtual LASO-3 program specifically for CIPN is relatively novel with limited prior trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Robert Knoerl — University of Michigan Rogel Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.