NCT02983279已完成不适用
Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery
Sidney Kimmel Cancer Center at Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年9月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in miR-21 expression assessed in serum
研究概览
简要总结
The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.
详细描述
PRIMARY OBJECTIVES:
- Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21 (miR-21) expression in patients with prostate, endometrial or breast cancer.
SECONDARY OBJECTIVES:
- Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction.
- Investigate the adherence of the patient to the diet.
- Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological documentation of cancer of the endometrium, prostate or breast.
- •Candidate for definitive cancer surgery as determined by treating physician
- •The ability for the definitive cancer surgery to be scheduled within 4-12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis - but from start of diet).
- •No other malignancy within the past 6 months unless it was a non-melanomatous skin lesion
- •ECOG Performance Status of 2 or less
- •Patient must not be on anti-retrovirals since they may alter patient metabolism
排除标准
- •Patient is not a candidate for definitive cancer surgery
- •Definitive cancer surgery can not be performed within 4-12 weeks post study enrollment as determined by the enrolling physician.
- •Body Mass Index < 21
- •Another malignancy within the past 6 months that was not a non-melanomatous skin lesion
- •ECOG Performance Status >2
- •Patient on anti-retrovirals since they may alter patient metabolism
研究组 & 干预措施
Dietary counseling, caloric restriction diet
Experimental
Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
干预措施: Dietary Intervention (Dietary Supplement)
Dietary counseling, caloric restriction diet
Experimental
Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
干预措施: Counseling (Other)
Dietary counseling, caloric restriction diet
Experimental
Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
干预措施: Therapeutic (Procedure)
结局指标
主要结局
Change in miR-21 expression assessed in serum
时间窗: Baseline up to 12 weeks
Will be evaluated by a two-sided paired t-test at significance level 0.05.
次要结局
- Change in prostate tumor gene expression(Baseline up to 12 weeks)
- Change in weight, defined as a percent change(Baseline up to 12 weeks)
- Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target(Up to 12 weeks)
- Change in body composition, assessed via BodyMetrix(Baseline up to 12 weeks)
- Change in genomic expression of microRNA 21 (miR-21)(Baseline to after definitive surgery)
- Change in insulin(Baseline up to 12 weeks)
- Change in biome analysis assessed by rectal swab(Baseline to 12 weeks)
- Change in psycho-social outcomes, assessed by the FACT-B(Baseline up to 12 weeks)
- Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)(Baseline up to 12 weeks)
- Local recurrence, assessed through patient records(From the date of study enrollment to time of event, assessed up to 12 weeks)
- Distant metastases, assessed through patient records(From the date of study enrollment to time of event, assessed up to 12 weeks)
- Change in temperature(Baseline up to 12 weeks)
- Progression free survival, assessed through patient records(From the date of study enrollment to time of event, assessed up to 12 weeks)
- Overall survival, assessed through patient records(From the date of study enrollment to time of event, assessed up to 12 weeks)
- Change in weight, defined by body mass index as weight in kg divided by height in meters squared(Baseline up to 12 weeks)
- Change in blood pressure(Baseline up to 12 weeks)
- Change in heart rate(Baseline up to 12 weeks)
- Change in respiratory rate(Baseline up to 12 weeks)
- Change in psycho-social outcomes, assessed by the FACT-En(Baseline up to 12 weeks)
- Change in psycho-social outcomes, assessed by the FACT-P(Baseline up to 12 weeks)
- Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form(Baseline up to 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation TherapyInvasive Ductal Breast CarcinomaStage IB Breast CancerRecurrent Breast CancerDuctal Breast Carcinoma in SituInvasive Lobular Breast CarcinomaLobular Breast Carcinoma in SituStage IA Breast CancerNCT01819233Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University38
进行中（未招募）
不适用
Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic SyndromePreDiabetesQuality of LifeMetabolic SyndromeOverweight or ObesityWeight LossNCT04328233Nicolaus Copernicus University30
招募中
不适用
Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular HealthMyocardial InfarctionNCT06007950Universiti Teknologi Mara48
已完成
不适用
Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT03700437Indiana University12
已完成
不适用
Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot StudyCancer SurvivorshipNCT04243512University of Rochester39