LASO-3 Diet for Peripheral Neuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Robert Knoerl
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for cancer survivors over 18 who finished neurotoxic chemotherapy at least three months ago, speak English, have internet access, and self-report moderate numbness or tingling. It's not suitable for those who don't meet these criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants attend virtual LASO-3 nutrition counseling sessions over 30 minutes weekly for 4 weeks, followed by sessions over 15 minutes bi-weekly for 8 weeks. Blood samples are collected throughout the trial.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of patient-reported outcome measures.
Extension
Participants may receive intervention materials and up to 4 dietary counseling sessions post-study.
What Are the Treatments Tested in This Trial?
Interventions
- LASO-3 Diet Intervention
Trial Overview
The LASO-3 diet intervention is being tested to see if it improves nerve damage symptoms caused by chemotherapy. Participants will receive virtual nutrition education from a dietitian focusing on reducing sugar, increasing fiber, and omega-3 fatty acids.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients attend virtual LASO-3 nutrition counseling sessions over 30 minutes QW for 4 weeks followed by LASO-3 nutrition counseling sessions over 15 minutes Q2W for 8 weeks. Patients also undergo blood sample collection throughout the trial.
Patients attend eight virtual general health education sessions over 15-30 minutes each over 12 weeks. Patients also undergo blood sample collection throughout the trial. Patients may also receive the intervention materials and up to 4 dietary counseling sessions post-study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
The Hope Foundation
Collaborator
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