CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Pathologic complete response assessed in tissue
研究概览
简要总结
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
详细描述
Primary objective:
I To determine if dietary alternations designed to downregulate the dominate molecular drivers of an individuals' breast cancer will enhance the effect of neoadjuvant chemotherapy and allow for an increase in the pathologic complete response rate.
Secondary objectives
I) Investigator measurable changes to molecular and patient characteristics from precision nutrition to determine a metric for evaluation this treatment in future studies.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven invasive breast cancer
- •Planned neoadjuvant chemotherapy determined by the judgment of the medical oncologist
- •The patient must be female
- •Non-metastatic and non-inflammatory breast cancer
- •History/physical examination, including breast exam and documentation of weight and Karnofsky Performance Status of 80-100% for at least 60 days prior to study entry.
- •Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during chemotherapy
- •Patient must capable of and provide study specific informed consent prior to study entry
- •Weight ≥120lbs
- •No prior history of non-breast malignancies in the past 1 year unless it was a non- melanomatous skin lesion or carcinoma in situ of the cervix.
- •Patient must not have Acquired Immune Deficiency Syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism.
- •Patient may not have any active Gastrointestinal/Malabsorption disorder at the discretion of the Principal Investigator which may include:
- •Chronic Pancreatitis
- •Chronic Diarrhea or Vomiting
- •Active Eating Disorder
- •No history of or current active drug/alcohol dependence.
- •No patients with decisional impairment.
排除标准
- •Patient is male.
- •Age <18 years
- •Clinical stage IV cancer
- •Inflammatory breast cancer (T4d)
- •Women of childbearing potential with a positive serum beta hCG.
- •Decision impaired patients.
- •BMI < 21
- •Weight < 120lbs
- •Weight loss ≥10% in the last 3 mos
- •Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 1 year prior to registration
- •Non-epithelial breast malignancies such as sarcoma or lymphoma
- •Active Gastrointestinal/Malabsorption disorder at the discretion of the Principal -Investigator which may include:
- •Chronic Diarrhea or Vomiting
- •Active Eating Disorder
- •Active drug/alcohol dependence or abuse history.
结局指标
主要结局
Pathologic complete response assessed in tissue
时间窗: At time of definitive breast surgery
The portion of patients who adhere to the diet restriction will be computed along with a 95% exact confidence. An exact binomial test (with a onesided alpha of 0.05) will also be used to test whether adherence is greater than 60%.
Incidence of adverse events evaluated by CTCAE version 4.0
时间窗: Up to 24 months
次要结局
- Number of study participants who receive the dietary intervention to the historical controls(Up to 24 months)
- Weight changes(Up to 24 months)
- Change in insulin(Up to 24 months)
- Distant metastases(Up to 24 months)
- Progression-free survival(Up to 24 months)
- Overall survival(Up to 24 months)
- Change in serum(Up to 24 months)