Clinical trial NCT02486796: Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Quality of Life
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Subject Reported Quality of Life Score
timeFrame: Initial visit and study visits at 3-week intervals up to 4 months
Secondary outcomes:
measure: Concentration of C-reactive Protein in Serum (mg/L)
timeFrame: Initial visit and study visits at 3-week intervals up to 4 months
measure: Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)
timeFrame: Initial visit and study visits at 3-week intervals up to 4 months
measure: Sedimentation Rate of Erythrocytes in Blood (mm/hr)
timeFrame: Initial visit and study visits at 3-week intervals up to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Midwestern Regional Medical Center, Inc.
name: Christina Shannon, ND
role: PRINCIPAL_INVESTIGATOR
References: