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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review; Other: Educational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Rogel Cancer Center
      • Contact: Robert Knoerl; Phone Number: 734-764-8617; Email: rjknoerl@med.umich.edu
      • Principal Investigator: Robert Knoerl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (LASO-3 sessions); 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.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies
Active Comparator: Arm II (general health education sessions); 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.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Educational Intervention; Attend virtual general health education sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of all participants (Feasibility)	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).	Up to 2 years
Completion of baseline and 12-week patient-reported outcome measures (Feasibility)	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.	At baseline and 12 weeks
Percent of LASO-3 participants who attend at least 5 out of 8 intervention sessions (Feasibility)	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.	Up to 12 weeks
Percent of LASO-3 participants who self-report adherence to dietary goals (Feasibility)	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.	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and satisfaction with the twelve-week LASO-3 diet intervention	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.	At 12 weeks

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: The Hope Foundation
• Investigators: Principal Investigator: Robert Knoerl, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Methods; Interviews as Topic; Early Intervention, Educational; Educational Status; Specimen Handling
• Other Study ID Numbers: UMCC 2025.077; NCI-2025-07988 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00274541 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we will only share de-identified data with others upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No