Recruiting

LASO-3

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07365007

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Educational Intervention

Electronic Health Record Review

Interview

Survey Administration

Study Details

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT07365007

Start date

Feb 23, 2026

Status verified date

Jun, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Educational Intervention

Attend virtual general health education sessions

Electronic Health Record Review

Ancillary studies

Interview

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Robert Knoerl

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-06-25.