Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Quality of Life

Intervention / Treatment
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* Biological: Reishi mushroom extract
* Drug: Coenzyme Q10
* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate and Continuous Dosing<br>Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. | Biological: Reishi mushroom extract<br>* Reishi mushroom preparation produced water-ethanol extraction.<br>* Other names: Ganoderma lucidum;Drug: Coenzyme Q10<br>* Preparation of coenzyme Q10<br>* Other names: Ubidecarenone;Drug: Melatonin<br>* Preparation of melatonin<br>* Other names: N-acetyl-5-methoxy tryptamine;|
| Active Comparator: Delayed Dosing<br>Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. | Biological: Reishi mushroom extract<br>* Reishi mushroom preparation produced water-ethanol extraction.<br>* Other names: Ganoderma lucidum;Drug: Coenzyme Q10<br>* Preparation of coenzyme Q10<br>* Other names: Ubidecarenone;Drug: Melatonin<br>* Preparation of melatonin<br>* Other names: N-acetyl-5-methoxy tryptamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Reported Quality of Life Score | 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. | Initial visit and study visits at 3-week intervals up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of C-reactive Protein in Serum (mg/L) | The serum concentration of C-reactive protein will be measured by approved methods. | Initial visit and study visits at 3-week intervals up to 4 months | 
| Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) | The serum concentration of circulating tumor cells will be measured by approved methods. | Initial visit and study visits at 3-week intervals up to 4 months | 
| Sedimentation Rate of Erythrocytes in Blood (mm/hr) | The erythrocyte sedimentation rate will be measured by approved methods. | Initial visit and study visits at 3-week intervals up to 4 months |