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Идёт набор NCT07365007

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

Без фазы С лечением Chemotherapy-Induced Peripheral Neuropathy Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biospecimen Collection, Educational Intervention, Electronic Health Record Review, Interview.
Кому может быть актуально
Состояния в реестре: Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Процедура Biospecimen Collection
    Undergo blood sample collection
  • Другое Educational Intervention
    Attend virtual general health education sessions
  • Другое Electronic Health Record Review
    Ancillary studies
  • Другое Interview
    Ancillary studies
  • Другое Survey Administration
    Ancillary studies

Первичные конечные точки

  • Recruitment of all participants (Feasibility) [Срок оценки: Up to 2 years]
  • Completion of baseline and 12-week patient-reported outcome measures (Feasibility) [Срок оценки: At baseline and 12 weeks]
  • Percent of LASO-3 participants who attend at least 5 out of 8 intervention sessions (Feasibility) [Срок оценки: Up to 12 weeks]
  • Percent of LASO-3 participants who self-report adherence to dietary goals (Feasibility) [Срок оценки: Up to 24 weeks]
Вторичные конечные точки (1)
  • Acceptability and satisfaction with the twelve-week LASO-3 diet intervention [Срок оценки: At 12 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Michigan Rogel Cancer Center — Ann Arbor

Идентификаторы

NCT: NCT07365007 · UMCC 2025.077 · NCI-2025-07988 · HUM00274541

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗