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

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

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life
• Intervention / Treatment: Biological: Reishi mushroom extract; Drug: Coenzyme Q10; Drug: Melatonin

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Biological: Reishi mushroom extract; Reishi mushroom preparation produced water-ethanol extraction.; Other Names: Ganoderma lucidum; Drug: Coenzyme Q10; Preparation of coenzyme Q10; Other Names: Ubiquinone; Ubidecarenone; Drug: Melatonin; Preparation of melatonin; Other Names: N-acetyl-5-methoxy tryptamine
Active Comparator: 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.	Biological: Reishi mushroom extract; Reishi mushroom preparation produced water-ethanol extraction.; Other Names: Ganoderma lucidum; Drug: Coenzyme Q10; Preparation of coenzyme Q10; Other Names: Ubiquinone; Ubidecarenone; Drug: Melatonin; Preparation of melatonin; Other Names: N-acetyl-5-methoxy tryptamine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Midwestern Regional Medical Center
• Investigators: Principal Investigator: Christina Shannon, ND, Midwestern Regional Medical Center, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2016
• Primary Completion (Actual): March 3, 2017
• Study Completion (Actual): March 3, 2017

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Micronutrients; Vitamins; Antioxidants; Melatonin; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: MZ2014018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No