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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: Electronic Health Record Review
    Ancillary studies
  • Other: Interview
    Ancillary studies
  • Other: Survey Administration
    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: Educational Intervention
    Attend virtual general health education sessions
    Other names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Electronic Health Record Review
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies

Recruiting Locations

University of Michigan Rogel Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Robert Knoerl
734-764-8617
rjknoerl@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan Rogel Cancer Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.