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Идёт набор NCT06733363

A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer

Фаза II С лечением Non-Muscle Invasive Bladder Carcinoma Recurrent Bladder Carcinoma Recurrent Non-Muscle Invasive Bladder Carcinoma Stage 0a Bladder Cancer AJCC v8

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: Behavioral Dietary Intervention, Telephone- Based Intervention.
Кому может быть актуально
Состояния в реестре: Non-Muscle Invasive Bladder Carcinoma, Recurrent Bladder Carcinoma, Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8. 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
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Официальное название

A Scalable Cruciferous Vegetable Intervention to Reduce Bladder Cancer Recurrence and Progression

Обзор

This phase II trial is being done to develop and test a healthy eating program to reduce cancer recurrence (cancer that has come back after a period of improvement) and/or progression (cancer that is growing, spreading, or getting worse) in patients with non-muscle invasive bladder cancer (NMIBC). Researchers want to better understand how incorporating more cruciferous vegetables in the diet may reduce the risk of cancer recurrence or progression in men and women who were diagnosed with early-stage bladder cancer and compare whether extending the program can further improve bladder cancer outcomes. POW-R Health is a behavioral dietary intervention designed to modestly increase cruciferous vegetable (cruciferae) intake in patients. Cruciferous vegetables, such as cabbage, kale and broccoli, arugula, contain phytochemicals known as isothiocyanates (ITCs). Dietary ITCs exert potent anticancer activities against bladder cancer and can be rapidly metabolized, delivered to the bladder, and concentrated in the urine. Participating in the healthy eating program may reduce bladder cancer recurrence or progression in NMIBC survivors.

Подробное описание

PRIMARY OBJECTIVES:

I. Develop a maintenance component to add onto our POW-R Health intervention (POW-R Health Only/Core) to create POW-R Health + Maintenance.

II. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core using a 2-group randomized controlled trial (RCT) design in 344 participants on the primary outcome of urinary ITC.

SECONDARY OBJECTIVE:

I. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core on the secondary outcome of cruciferae intake.

Вмешательства

  • Поведенческое Behavioral Dietary Intervention
    Participate in POW-R Health Only/Core program
  • Поведенческое Telephone- Based Intervention
    Receive live phone calls

Первичные конечные точки

  • Urinary isothiocyanates (ITCs) levels [Срок оценки: Baseline throughout life of study - up to 24 months]
Вторичные конечные точки (1)
  • Increase in Cruciferae Intake [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

  • English speaking
  • Diagnosed with stage Tis, Ta, or T1 bladder cancer
  • Age 18 years old or older (no upper limit)
  • Resides in New York State
  • Cancer not reported by a lab, nursing home, or death certificate/autopsy only
  • Did not receive a partial or radical cystectomy
  • Does not have other cancer diagnosis within 12 month of bladder cancer diagnosis except for cancers deemed low risk and unlikely to impact study participation (e.g., basal cell carcinoma, nor under active treatment for any other cancers

Критерии исключения

  • Participants who had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Adults unable to consent
  • Adults unable to complete study measures in English
  • Individuals who are not yet adults (infants, children, teenagers)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Unwilling or unable to follow protocol requirements
  • The following special populations ae excluded from this study:
  • Cognitively impaired adults/adults with impaired decision-making capacity
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

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
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Roswell Park Comprehensive Cancer Center — Buffalo

Идентификаторы

NCT: NCT06733363 · I-4207024 · R01CA296175

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗