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

NCT02486796 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: MZ2014018
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Concentration of C-reactive Protein in Serum (mg/L)

  Initial visit and study visits at 3-week intervals up to 4 months

• Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)

  Initial visit and study visits at 3-week intervals up to 4 months

• Sedimentation Rate of Erythrocytes in Blood (mm/hr)

  Initial visit and study visits at 3-week intervals up to 4 months

Study Arms (2)

Immediate and Continuous Dosing

ACTIVE COMPARATOR

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; Drug: Coenzyme Q10; Drug: Melatonin

Delayed Dosing

ACTIVE COMPARATOR

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; Drug: Coenzyme Q10; Drug: Melatonin

Interventions

Reishi mushroom extract BIOLOGICAL

Reishi mushroom preparation produced water-ethanol extraction.

Also known as: Ganoderma lucidum

Delayed Dosing; Immediate and Continuous Dosing

Coenzyme Q10 DRUG

Preparation of coenzyme Q10

Also known as: Ubiquinone, Ubidecarenone

Delayed Dosing; Immediate and Continuous Dosing

Melatonin DRUG

Preparation of melatonin

Also known as: N-acetyl-5-methoxy tryptamine

Delayed Dosing; Immediate and Continuous Dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwestern Regional Medical Center: lead

MeSH Terms

Interventions

coenzyme Q10; Ubiquinone; Melatonin

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Director of ClinicalResearch
• Organization: Midwestern Regional Medical Center, Inc.

Bruce.Steinert@CTCA-Hope.com

847-731-1648

Study Officials

• Christina Shannon, ND

  Midwestern Regional Medical Center, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: February 19, 2016
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share