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

NCT ID: NCT02486796

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-19
• Study Completion Date: 2017-03-03

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.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Reishi mushroom extract

Intervention Type: BIOLOGICAL

Reishi mushroom preparation produced water-ethanol extraction.

Coenzyme Q10

Intervention Type: DRUG

Preparation of coenzyme Q10

Melatonin

Intervention Type: DRUG

Preparation of melatonin

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.

Group Type: ACTIVE_COMPARATOR

Reishi mushroom extract

Intervention Type: BIOLOGICAL

Reishi mushroom preparation produced water-ethanol extraction.

Coenzyme Q10

Intervention Type: DRUG

Preparation of coenzyme Q10

Melatonin

Intervention Type: DRUG

Preparation of melatonin

Interventions

Reishi mushroom extract

Reishi mushroom preparation produced water-ethanol extraction.

Intervention Type: BIOLOGICAL

Coenzyme Q10

Preparation of coenzyme Q10

Intervention Type: DRUG

Melatonin

Preparation of melatonin

Intervention Type: DRUG

Other Intervention Names

Ganoderma lucidum; Ubiquinone; Ubidecarenone; N-acetyl-5-methoxy tryptamine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Midwestern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Shannon, ND

Role: PRINCIPAL_INVESTIGATOR

Midwestern Regional Medical Center, Inc.

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

MZ2014018

Identifier Type: -

Identifier Source: org_study_id