immediate or delayed naturopathic medicine in combination with neo-adjuvant chemotherapy for breast cancer

Conditions: Quality of Life

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.


Eligibility criteria:
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