Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Operational barriers prevent critical specimen analyses from being performed.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coenzyme Q10 | Drug | — | UNRESOLVED |
| Melatonin | Drug | — | UNRESOLVED |
| Reishi mushroom extract | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immediate and Continuous Dosing
- description
- Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.
- interventionNames
- Biological: Reishi mushroom extract
- Drug: Coenzyme Q10
- Drug: Melatonin
- type
- ACTIVE_COMPARATOR
- label
- Delayed Dosing
- description
- Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.
- interventionNames
- Biological: Reishi mushroom extract
- Drug: Coenzyme Q10
- Drug: Melatonin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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