PANCREATIC NUTRITIONAL PROGRAM (PNP): A Novel Weight Reduction Program in Overweight/Obese Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
This pilot clinical trial studies a pancreatic nutritional program for helping patients with stage I-III breast cancer who are overweight or obese lose weight. When patients have a high level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and other illnesses. Breast cancer patients who are overweight and obese are more likely to have their breast cancer return. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low, and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the change in body weight at 6 months post-intervention relative to baseline.
SECONDARY OBJECTIVES:
I. To examine changes in: body composition; body chemistry; physical fitness; inflammatory markers; deoxyribonucleic acid (DNA) repair capacity; and quality of life per the Functional Assessment of Cancer Therapy - Breast (FACT-B)+4, version 4 questionnaire at 6 months post-intervention relative to baseline.
II. To describe adverse events possibly related to wearing the glucometer sensor or following the pancreatic nutritional program (PNP) diet.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with early-stage breast cancer (stage I-III)
- •Patients who have or have not undergone chemotherapy are both eligible; if the patient has undergone chemotherapy she must have completed adjuvant chemotherapy for >= 3 months and =< 5 years prior to study enrollment
- •Postmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
- •Body mass index (BMI) of 25-33 kg/m^2
- •Patients must be willing to adhere to the PNP intervention and the entire 6-month study
- •All patients must have the ability and the willingness to sign a written informed consent
排除标准
- •Patients who are diabetic
- •Patients whose BMI falls outside the eligible range (< 25 kg/m^2 or > 33 kg/m^2)
- •Patients with stage IV breast cancer
- •Patients with Rheumatoid Arthritis and other inflammatory diseases that would impact correlative studies
结局指标
主要结局
Change in body weight
时间窗: Baseline to 6 months
Tested using the paired t-test, alpha = 0.05.
次要结局
- Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance)(Baseline to up to 6 months)
- Change in body composition (BMI)(Baseline to up to 6 months)
- Change in physical fitness (measured using a handgrip dynamometer)(Baseline to 6 months)
- Change in quality of life score (FACT-B+4)(Baseline to 6 months)
- Change in serum inflammatory markers (C-reactive protein; cytokines)(Baseline to 6 months)
- Compliance metrics (days glucometer sensor not utilized; days body weight not recorded; days journal entries not made; days meal cards not created; weekly counseling sessions missed)(12 weeks)
- DNA repair capacity (comet assay's mean olive tail moment; number of gamma-H2A histone family, member X foci)(Baseline to 6 months)
- Incidence of adverse events reported as possibly or definitely related to wearing the glucometer sensor following the PNP diet(Up to 6 months)