Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
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
PROCEDUREBiospecimen Collection
Undergo blood sample collection
OTHEREducational Intervention
Attend virtual general health education sessions
OTHERElectronic Health Record Review
Ancillary studies
OTHERInterview
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
University of Michigan Rogel Cancer Center
Hope Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment of all participants (Feasibility) | Up to 2 years | 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). |
| Completion of baseline and 12-week patient-reported outcome measures (Feasibility) | At baseline and 12 weeks | 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. |
| Percent of LASO-3 participants who attend at least 5 out of 8 intervention sessions (Feasibility) | Up to 12 weeks | 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. |
| Percent of LASO-3 participants who self-report adherence to dietary goals (Feasibility) | Up to 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and satisfaction with the twelve-week LASO-3 diet intervention | At 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Knoerl
University of Michigan Rogel Cancer Center
Outcome results
None listed