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

Midwestern Regional Medical Center

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Quality of Life

Treatments: Drug: Melatonin; Drug: Coenzyme Q10; Biological: Reishi mushroom extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02486796

MZ2014018

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Immediate and Continuous Dosing

Active Comparator group

Description:

Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.

Treatment:

Biological: Reishi mushroom extract

Drug: Coenzyme Q10

Drug: Melatonin

Delayed Dosing

Active Comparator group

Description:

Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.

Treatment:

Biological: Reishi mushroom extract

Drug: Coenzyme Q10

Drug: Melatonin