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

Sponsors

Lead Sponsor: Midwestern Regional Medical Center

Source Midwestern Regional Medical Center
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.

Overall Status Terminated
Start Date 2016-02-19
Completion Date 2017-03-03
Primary Completion Date 2017-03-03
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Subject Reported Quality of Life Score Initial visit and study visits at 3-week intervals up to 4 months
Secondary Outcome
Measure Time Frame
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
Enrollment 5
Condition
Intervention

Intervention Type: Biological

Intervention Name: Reishi mushroom extract

Description: Reishi mushroom preparation produced water-ethanol extraction.

Other Name: Ganoderma lucidum

Intervention Type: Drug

Intervention Name: Coenzyme Q10

Description: Preparation of coenzyme Q10

Intervention Type: Drug

Intervention Name: Melatonin

Description: Preparation of melatonin

Other Name: 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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Christina Shannon, ND Principal Investigator Midwestern Regional Medical Center, Inc.
Verification Date

2018-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Immediate and Continuous Dosing

Type: Active Comparator

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

Label: Delayed Dosing

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News