A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors Post-treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Educational Intervention, Electronic Health Record Review, Interview.
- Who it may be relevant to
- Registry conditions: Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors
Overview
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.
Detailed description
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).
Interventions
- Procedure Biospecimen Collection
Undergo blood sample collection - Other Educational Intervention
Attend virtual general health education sessions - Other Electronic Health Record Review
Ancillary studies - Other Interview
Ancillary studies - Other Survey Administration
Ancillary studies
Primary outcome measures
- Recruitment of all participants (Feasibility) [Time frame: Up to 2 years]
- Completion of baseline and 12-week patient-reported outcome measures (Feasibility) [Time frame: At baseline and 12 weeks]
- Percent of LASO-3 participants who attend at least 5 out of 8 intervention sessions (Feasibility) [Time frame: Up to 12 weeks]
- Percent of LASO-3 participants who self-report adherence to dietary goals (Feasibility) [Time frame: Up to 24 weeks]
Secondary outcome measures (1)
- Acceptability and satisfaction with the twelve-week LASO-3 diet intervention [Time frame: At 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Michigan Rogel Cancer Center — Ann Arbor
Identifiers
NCT: NCT07365007 · UMCC 2025.077 · NCI-2025-07988 · HUM00274541