A Comparison Study to Assess the Value of Naturopathic Medicine Given Immediately and Continuously or Delayed Until Cycle 3 in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 主要终点
- Subject Reported Quality of Life Score
研究概览
简要总结
This study is examine the effect of the addition of naturopathic on immunologic and/or inflammatory parameters and/or quality of life in women receiving neoadjuvant chemotherapy for breast cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Biopsy proven diagnosis of invasive adenocarcinoma of the breast
- •Recommendation for neoadjuvant chemotherapy.
- •Left Ventricular Ejection Fraction (LVEF) assessment by multigated acquisition scan or echocardiogram within 3 months of entering study
- •Blood counts:
- •Absolute Neutrophil Count ≥1200 cells/mm^3
- •Platelet count ≥100,000/mm^3
- •Hemoglobin ≥10g/dL
- •Serum creatinine ≤ Upper Limit of Normal (ULN) for the laboratory range
- •Total bilirubin ≤ ULN for the laboratory range, unless the patient has an elevation >ULN to 1.5 times the ULN resulting from Gilbert's disease or similar syndrome
- •Alkaline phosphatase less than or equal to 2.5 x ULN; and
- •Aspartate aminotransferase (AST) less than or equal to 1.5 x ULN for the laboratory range
- •If skeletal pain present or alkaline phosphatase >ULN (but less than or equal to 2.5x ULN), bone scan or Positron Emission Tomography (PET) scan must not demonstrate metastatic disease
- •AST or alkaline phosphatase greater than ULN, no metastatic disease liver identified by CT, MRI or PET scan
- •Able to swallow oral medication
- •Willing to forego naturopathic treatment for the first 2 treatment cycles
- •Willing to start and continue naturopathic interventions as prescribed
- •Willing to forego the use of nutritional or botanical supplements during the study
排除标准
- •Stage 4 disease
- •Present treatment with Warfarin.
- •Synchronous bilateral invasive breast cancer
- •Treatment including radiation, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to entering study
- •Any sex hormonal therapy e.g. birth control, ovarian hormone replacement therapy, etc. during participation in the study)
- •Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators
- •Prior history of breast cancer, including Ductal Carcinoma In Situ (subjects with a history of Lobular Carcinoma In Situ are eligible)
- •Prior therapy with chemotherapy or targeted therapy agents for any malignancy
- •Cardiac disease that would preclude the use of the certain drugs. This includes but is not confined to:
- •Active cardiac disease
- •Angina pectoris requiring treatment
- •Ventricular arrhythmias except controlled benign premature ventricular contractions
- •Conduction abnormality requiring a pacemaker
- •Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled by medication
- •Clinical significant valvular disease
- •History of cardiac disease
- •Myocardial infarction
- •Congestive heart failure
- •Cardiomyopathy
- •Uncontrolled hypertension, (blood pressure above 150/90 mm/Hg on antihypertensive treatment)
- •History or current symptomatic interstitial pneumonitis or pulmonary fibrosis
- •Sensory/motor neuropathy ≥ grade 2
- •Malabsorption syndrome, ulcerative colitis, resection the stomach or small bowel, or other disease significantly affecting gastrointestinal function
- •Other non-malignant systemic disease precluding treatment with study regimens or required follow up
- •Contraindication of corticosteroids
- •Administration of an investigational agent within 30 days prior to entering study.
- •Administration of therapeutic doses of the supplements being studied including maitake, melatonin and Coenzyme Q10 in the previous 30 days.
- •Administration of therapeutic doses of immune modulating botanicals in the previous 30 days.
- •Pregnancy or lactation
研究组 & 干预措施
Immediate and Continuous Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.
干预措施: Reishi mushroom extract (Biological)
Immediate and Continuous Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.
干预措施: Coenzyme Q10 (Drug)
Immediate and Continuous Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.
干预措施: Melatonin (Drug)
Delayed Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.
干预措施: Reishi mushroom extract (Biological)
Delayed Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.
干预措施: Coenzyme Q10 (Drug)
Delayed Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.
干预措施: Melatonin (Drug)
结局指标
主要结局
Subject Reported Quality of Life Score
时间窗: Initial visit and study visits at 3-week intervals up to 4 months
Subject quality of life as measured by a self-administered questionnaire (0 to 10 Likert scale with 0=No Effect to 10=Worst Effect) at each study visit. The symptoms or impact on activities scored included: Pain, Fatigue, Nausea, Sleep Disturbance, Distress, Shortness of Breath, Memory/Recall Problems, Appetite, Drowsiness, Dry Mouth, Sadness, Vomiting, Numbness, General Activities, Mood, Work, Relationships, Walking or Enjoyment.
次要结局
- Concentration of C-reactive Protein in Serum (mg/L)(Initial visit and study visits at 3-week intervals up to 4 months)
- Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)(Initial visit and study visits at 3-week intervals up to 4 months)
- Sedimentation Rate of Erythrocytes in Blood (mm/hr)(Initial visit and study visits at 3-week intervals up to 4 months)