A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of Participants Who Are Adherent to the Diet Restriction
研究概览
简要总结
This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor cells.
详细描述
PRIMARY OBJECTIVE:
- Investigate the feasibility of a clinical trial administering ionizing radiation with concurrent caloric restriction (CR) for the treatment of breast cancer.
SECONDARY OBJECTIVE: 2. Investigate measurable changes of patient characteristics and tissue and serum from CR conditions to determine a metric for evaluating this treatment in future studies.
OUTLINE:
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy once daily (QD) 5 days a week for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer
- •Ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes
- •The patient must be female
- •If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision
- •Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
- •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
- •Ipsilateral mammogram within 6 months prior to study entry
- •Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry
- •Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- •Patient must capable of and provide study specific informed consent prior to study entry
- •Body mass index (BMI) >= 21
- •Weight >= 100 lbs
- •No prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix
- •Patient must not have any of the following severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- •Acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive based upon current Centers for Disease and Control (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 must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- •No prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
- •Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator
- •Inflammatory bowel disease
- •Celiac disease
- •Chronic pancreatitis
- •Chronic diarrhea or vomiting
- •Active eating disorder
- •Creatinine < 1.7
- •Not currently taking steroids
- •No currently active pituitary secreting tumors up to physician discretion
- •No history of or current active drug/alcohol dependence
- •No patients being decisionally impaired
排除标准
- •Patient is not a candidate for breast conservation
- •Patient is male
- •Age < 18 years
- •Patient requires regional lymph node irradiation therapy
- •Patient has evidence of distant metastases
- •Karnofsky performance status less than 80% within 60 days prior to study
- •Ipsilateral mammogram done greater than 6 months prior to study
- •Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)
- •Patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines
- •Weight < 100 lbs
- •Weight loss >= 10% in the last 3 months (mos)
- •Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration
- •Two or more breast cancers not resectable through a single lumpectomy incision
- •Non-epithelial breast malignancies such as sarcoma or lymphoma
- •Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- •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
- •Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- •Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator
- •Inflammatory bowel disease
- •Celiac disease
- •Chronic pancreatitis
- •Chronic diarrhea or vomiting
- •Active eating disorder
- •Creatinine >= 1.7
- •Current use of steroids
- •Pituitary secreting tumors up to physician discretion
- •Active drug/alcohol dependence or abuse history
- •Decisionally impaired patients
研究组 & 干预措施
Behavioral dietary intervention
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
干预措施: Behavioral dietary intervention (Behavioral)
Behavioral dietary intervention
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
干预措施: Therapeutic conventional surgery (Procedure)
Behavioral dietary intervention
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
干预措施: Radiation therapy (Radiation)
Behavioral dietary intervention
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
干预措施: Counseling intervention (Other)
Behavioral dietary intervention
Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
干预措施: Quality-of-life assessment (Procedure)
结局指标
主要结局
Number of Participants Who Are Adherent to the Diet Restriction
时间窗: Up to week 12
Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.
次要结局
- Change in Body Fat Measurement(Baseline to 4 weeks after completion of study)
- Progression Free Survival(Up to 4 weeks after completion of study)
- Overall Survival(Up to 4 weeks after completion of study)
- Change in Body Mass Index (BMI)(Baseline to 4 weeks after completion of study)
- Change in Heart Rate Over Time(Baseline to 4 weeks after completion of study)
- Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)(Baseline to 4 weeks after completion of study)
- Local Recurrence(Up to 4 weeks after completion of study)
- Distant Metastases(Up to 4 weeks after completion of study)
- Patterns of Change Over Time in Serum Markers(Baseline to 4 weeks after completion of study)