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

Immediate or Delayed Naturopathic Medicine 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 February 19, 2016
Completion Date March 3, 2017
Primary Completion Date March 3, 2017
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

July 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Immediate and Continuous Dosing

Arm group 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.

Arm group label: Delayed Dosing

Arm group 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)

Source: ClinicalTrials.gov