Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance

Официальное название

Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance

Обзор

This clinical trial compares two different weight-loss programs, daily continuous calorie energy reduction (CER) versus (vs.) 5:2 intermittent fasting (IF), in preventing progression of kidney (renal) cancer among patients with one or more small renal masses (SRM) undergoing active surveillance (AS). Kidney cancer patients tend to have changes in metabolism that may increase body weight, but weight-loss strategies that work for best for these patients are unknown. The CER program requires a set daily limit for calories. The IF program requires fasting for 2 days a week and normal eating for the remaining 5 days. Both will include self-monitoring with interventionist feedback. This trial may help researchers determine whether the IF program works better than the CER program in improving weight loss, physical health, and/or reducing the risk of kidney cancer progression among patients with small renal masses undergoing AS

Подробное описание

PRIMARY OBJECTIVES:

I. Adapt two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in SRM patients on AS.

II. Determine the feasibility of the two intervention programs (IF and CER).

SECONDARY OBJECTIVE:

I. Measure and explore preliminary effect sizes of IF vs. CER on body weight, diet, body composition, tumor growth, and rates of clinical progression and invasive treatment conversion

Вмешательства

• Другое Intermittent Fasting
  The IF intervention will instruct participants how to fast safely, how to conduct a 5:2 fast, and encourage moderate physical activity. Self-monitoring with interventionist feedback will also be included
• Другое Continuous Energy Restriction (CER)
  Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback

Первичные конечные точки

• Participation Rate [Срок оценки: At 6 months]

Вторичные конечные точки (4)

• Change in tumor size [Срок оценки: At baseline and at 6 months]
• Rate of clinical progression [Срок оценки: Up to 6 months]
• Recall of Dietary Intake [Срок оценки: Baseline and 6 months]
• Change in Body composition [Срок оценки: Baseline and at 6 months]

Критерии участия

Критерии включения

• English speaking
• SRM patient with biopsy-confirmed RCC who are initiating or already on AS for less than 5 years
• Age 18 years or older
• Body mass index (BMI) ≥ 25 kg/m\^2
• No medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
• No current medication that might affect weight loss
• Not pregnant or lactating
• No more than 5% body weight loss in the past 3 months
• No bariatric surgery in the last 10 years

Критерии исключения

• Non-English speaking
• Less than 18 years old
• BMI < 25 kg/m\^2
• Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
• Current medication that might affect weight loss
• Pregnant or lactating
• More than 105% body weight loss in the past 6 months
• Bariatric surgery in the last 10 years
• Medical conditions that might contraindicate short-term fasting periods
• Unwilling or unable to follow protocol requirements
• Received an investigational agent within 30 days prior to enrollment

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

Профилактика

Центры проведения

США · 1 центр

• Roswell Park Comprehensive Cancer Center — Buffalo

Идентификаторы

NCT: NCT07714018 · I-4928826

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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