A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Rate of chemotherapy-related toxicity
研究概览
简要总结
This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment
详细描述
PRIMARY OBJECTIVES:
I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer.
II. To evaluate the compliance with a controlled diet intervention.
III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF binding protein (IGFBP) levels in subjects who consume a restricted diet compared to controls.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting OR metastatic prostate adenocarcinoma for which Docetaxel will be administered
- •Body mass index (BMI) >= 18.5
- •Subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
- •Prior therapy:
- •Breast cancer subjects may not have received prior chemotherapy, with the exception of curative-intent chemotherapy for a separate malignancy more than 3 years ago
- •Prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic
- •Prostate cancer subjects may be receiving a 2nd course of docetaxel provided that ** The first course resulted in a PSA response (> 30% reduction in prostate specific antigen [PSA] and/or improvement in radiographic findings or pain) and the last dose was >= 9 months ago
- •Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2x upper limit of normal (ULN)
- •Absolute neutrophil count (ANC) > 1500
- •Platelets (plts) > 90,000
- •Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
排除标准
- •Diabetes Mellitus
- •Peripheral Neuropathy >= grade 1
- •Prior therapy with inhibitors of IGF-1
- •Concurrent use of somatostatin
- •Significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)
研究组 & 干预措施
Arm II (normal diet)
Patients eat a normal diet and receive dietary advice which may include consultation with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.
干预措施: nutritional support (Procedure)
Arm I (low-calorie diet)
Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 2 days after chemotherapy. Patients are provided with all meals and all food to be consumed and maintain a diary of the food consumed and appropriate amounts.
干预措施: dietary intervention (Dietary Supplement)
Arm I (low-calorie diet)
Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 2 days after chemotherapy. Patients are provided with all meals and all food to be consumed and maintain a diary of the food consumed and appropriate amounts.
干预措施: laboratory biomarker analysis (Other)
Arm II (normal diet)
Patients eat a normal diet and receive dietary advice which may include consultation with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Rate of chemotherapy-related toxicity
时间窗: Up to 12 weeks
Occurrence of Grade 2+ non-hematologic symptomatic toxicity (fatigue, nausea and vomiting, anorexia, neuropathy, mucositis, cystitis, stomatitis), evaluated according to Common Terminology Criteria for Adverse Events version 4.0. The two arms will be compared, in terms of the proportion of patients with the occurrence of one of these toxicities.
次要结局
- Tumor response(Up to 12 weeks)