Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer
Phase 1
Terminated
- Conditions
- Quality of Life
- Interventions
- Registration Number
- NCT02486796
- Lead Sponsor
- Midwestern Regional Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 5
Inclusion Criteria
- Female
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate and Continuous Dosing Reishi mushroom extract Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Immediate and Continuous Dosing Coenzyme Q10 Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Immediate and Continuous Dosing Melatonin Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Delayed Dosing Reishi mushroom extract Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Delayed Dosing Coenzyme Q10 Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Delayed Dosing Melatonin Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.
- Primary Outcome Measures
Name Time Method Subject Reported Quality of Life Score 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.
- Secondary Outcome Measures
Name Time Method Concentration of C-reactive Protein in Serum (mg/L) Initial visit and study visits at 3-week intervals up to 4 months The serum concentration of C-reactive protein will be measured by approved methods.
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) Initial visit and study visits at 3-week intervals up to 4 months The serum concentration of circulating tumor cells will be measured by approved methods.
Sedimentation Rate of Erythrocytes in Blood (mm/hr) Initial visit and study visits at 3-week intervals up to 4 months The erythrocyte sedimentation rate will be measured by approved methods.