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


Primary Investigator
Knoerl, Robert
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT07365007
UM Number
2025.077
Age Group
Both
Management Group
CTSU - Oncology
Oncology Group
Cancer Control and Prevention
ID (Protocol)
62954
Secondary Protocol No
HUM00274541
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed

Disease Site
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Hodgkin's Lymphoma
Ill-Defined Sites
Kaposi's Sarcoma
Kidney
Larynx
Leukemia, other
Lip, Oral Cavity and Pharynx
Liver
Lung
Lymphoid Leukemia
Melanoma, Skin
Multiple Myeloma
Mycosis Fungoides
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Hematopoietic
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder

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.

Eligibility: 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