Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07365007

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

Led by University of Michigan Rogel Cancer Center · Updated on 2026-03-03

50

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

Sponsors

U

University of Michigan Rogel Cancer Center

Lead Sponsor

H

Hope Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Pre-existing neuropathy from any cause
  • Plan to begin a new prescription of duloxetine (first-line treatment for CIPN pain) during the study period
  • Enrollment in symptom management trials that may alter CIPN severity
  • Current inflammatory disease
  • Routine nonsteroidal anti-inflammatory drug (NSAID) or steroid supplementation
  • Consuming three or more servings of fish per week and/or daily fish oil capsules containing EPA+DHA or daily flax oil capsules
  • Consuming less than 5 servings per week of sweets, candy bars, chocolate, doughnuts, cookies, cakes, pie, brownies, ice cream, pastries, or sugar sweetened beverages (e.g., soda or coffee/tea)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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