NCT07365007 A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors Post-treatment
| NCT ID | NCT07365007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Chemotherapy-Induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-02-23 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 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
Contact & Investigator
Robert Knoerl
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT07365007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07365007 currently recruiting?
Yes, NCT07365007 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Michigan Rogel Cancer Center to inquire about joining.
Where is the NCT07365007 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07365007 clinical trial?
NCT07365007 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Robert Knoerl at University of Michigan Rogel Cancer Center. The trial plans to enroll 50 participants.