Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance
2026年8月18日 更新者：Roswell Park Cancer Institute
Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance
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
研究概览
详细说明
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, compare 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
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：ASK RPCI
- 电话号码：1-800-767-9355
- 邮箱：askroswell@roswellpark.org
学习地点
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New York
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Buffalo、New York、美国、14263
- 招聘中
- Roswell Park Comprehensive Cancer Center
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接触：
- ASK RPCI
- 电话号码：800-767-9355
- 邮箱：askrpci@roswellpark.org
-
首席研究员：
- Eric Kauffmann, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- English speaking
- SRM patient with biopsy-confirmed RCC who are initiating or already on AS
- 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 weight loss medication in the past 3 months
- Not pregnant or lactating
- No more than 5% body weight loss in the past 3 months
- No bariatric surgery in the last 10 years
Exclusion Criteria:
- 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
- On weight loss medication in the past 3 months
- Pregnant or lactating
- More than 5% body weight loss in the past 3 months
- Bariatric surgery in the last 10 years
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
- Unwilling or unable to follow protocol requirements
- Received an investigational agent within 30 days prior to enrollment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Arm I - CER Program
Patients complete the CER program for 6 months.
The CER intervention will be adapted to renal cell carcinoma patients on active surveillance
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Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
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有源比较器：Arm II - IF Program
Patients will complete the IF program for 6 months.
The IF arm will mirror the CER arm with the exception that IF additionally include 2 fasting days per week during which participants will be instructed to eat one 500-600kcal meal per fasting day.
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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
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participation Rate
大体时间：At 6 months
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This will assess the rate of eligible persons who enroll after invitation and the mean proportion of intervention components completed by arm and participant
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At 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in tumor size
大体时间：At baseline and at 6 months
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Will be assessed based on radiologic imaging.
Within-group differences between baseline and 6 months will be examined using paired t-tests or Wilcoxon signed-rank tests for continuous variables, and McNemar's test for categorical variables.
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At baseline and at 6 months
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Rate of clinical progression
大体时间：Up to 6 months
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defined based on radiologic tumor size (> 4 cm), stage (> cT1a) and growth rate (> 5 mm/year for < 3 cm size; > 3 mm/year for tumor size > 3 cm), in addition to biopsy histology (high grade or unclassified renal cell carcinoma histologic subtype) and patient symptomology (bleeding or paraneoplastic symptoms/signs attributable to the tumor), as per the International Consultation for Urologic Disease guidelines
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Up to 6 months
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Change in Body composition
大体时间：Baseline and at 6 months
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Will be measured using a body composition monitor, which uses bioelectrical impedance analysis to measure whole body and segmental body composition, including trunk fat..
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Baseline and at 6 months
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Change in Dietary Intake
大体时间：Baseline and 6 months
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Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period.
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Baseline and 6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Eric Kaufmann、Roswell Park Comprehensive Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月15日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月20日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.