Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence and compliance to the ketogenic diet
研究概览
简要总结
This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in affecting the return of cancer in patients with stage IV breast cancer. Ketogenic diet may be more effective than standard nutrition and may affect quality of life, inflammation, and tumor-related changes. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ketogenic diet and chemotherapy may be better in patients with breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of implementing a diet that induces nutritional ketosis in women who are initiating palliative chemotherapy to treat advanced stage breast cancer (BC).
II. To determine the effects of a ketogenic diet on tumor progression. III. To determine the effects of nutritional ketosis on biologic and behavioral health markers.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients receive standard of care therapy with paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Body mass index (BMI) >= 22 kg/m^2
- •Confirmed diagnosis of metastatic or stage IV BC
- •Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) avid tumors
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (0=participant has either normal activity, 1= participant has some symptoms but is nearly full ambulatory)
- •Life expectancy > 6 months
- •Able and willing to follow prescribed diet intervention
排除标准
- •Prior chemotherapy for metastatic breast cancer (MBC) (prior adjuvant chemotherapy permitted as long as > 12 months [mo])
- •BMI < 25 kg/m^2
- •Weight change > 5% within 3 months of enrollment
- •Type 1 diabetes
- •History of diabetes with retinopathy requiring treatment
- •Current use of insulin or sulfonylureads for glycemic control, or history of ketoacidosis
- •Intestinal obstruction
- •Bilirubin > 2
- •Albumin < 3.5
- •Glomerular filtration rate (GFR) < 55 mL/min
- •Creatinine > 2.0
- •Urinary albumin > 1 g/day
- •Congestive heart failure
- •Pregnant or nursing women
- •Unable to provide informed consent
- •Uncontrolled concurrent medical conditions that would limit compliance with study requirements
研究组 & 干预措施
Arm I (standard of care)
Patients receive standard of care therapy with paclitaxel.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (standard of care)
Patients receive standard of care therapy with paclitaxel.
干预措施: Paclitaxel (Drug)
Arm I (standard of care)
Patients receive standard of care therapy with paclitaxel.
干预措施: Quality-of-Life Assessment (Other)
Arm I (standard of care)
Patients receive standard of care therapy with paclitaxel.
干预措施: Questionnaire Administration (Other)
Arm II (standard of care, ketogenic diet)
Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.
干预措施: Dietary Intervention (Dietary Supplement)
Arm II (standard of care, ketogenic diet)
Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (standard of care, ketogenic diet)
Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.
干预措施: Paclitaxel (Drug)
Arm II (standard of care, ketogenic diet)
Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.
干预措施: Quality-of-Life Assessment (Other)
Arm II (standard of care, ketogenic diet)
Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Adherence and compliance to the ketogenic diet
时间窗: Up to 26 weeks
Summaries from diet assessments and ketone logs will be plotted over time to assess adherence and compliance to the ketogenic diet.
Changes in psychosocial measures
时间窗: Baseline up to 26 weeks
Summary measures such as Cohens d will be used. Linear and nonlinear mixed models will be used as appropriate to model changes in tumor markers, comorbidity risk factors, and other measures over time, with emphasis will be on estimating effect sizes (such as slopes of change). Post hoc tests will be used to examine pairwise comparisons when significant main or interaction effects are observed. The alpha level for significance will be set at p =\< 0.05.
Changes in physiologic outcomes
时间窗: Baseline up to 26 weeks
Summary measures such as Cohens d will be used. Linear and nonlinear mixed models will be used as appropriate to model changes in tumor markers, comorbidity risk factors, and other measures over time, with emphasis will be on estimating effect sizes (such as slopes of change). Post hoc tests will be used to examine pairwise comparisons when significant main or interaction effects are observed. The alpha level for significance will be set at p =\< 0.05.
次要结局
未报告次要终点
研究者
Jeff Volek
Principal Investigator
Ohio State University Comprehensive Cancer Center