Clinical trial · Interventional
Clinical Trial of Trametes Versicolor in Women With Breast Cancer
Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer
NCT00680667CI-TRIAL-00030568completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may be an effective treatment for breast cancer. PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor extract in treating women with stage I, stage II, or stage III breast cancer who have finished radiation therapy.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coriolus versicolor extract | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trametes Versicolor
- description
- Females with Stage I-III infiltrating ductal adenocarcinoma of the breast being treated with Trametes versicolor capsules for 6 weeks after receiving radiation therapy.
- interventionNames
- Biological: Coriolus versicolor extract
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- Up to 6 Weeks After Treatment
Secondary outcomes (5)
- measure
- Quality of life
- timeFrame
- Over 6 Weeks
- description
- as measured by the Functional Assessment of Cancer Therapy-for Patients With Breast, v4.0, questionnaire. The FACT-B is a 37-item quesionnaire using a 5-point Likert scale that evaluates physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns of breast cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis, within the previous 12 months with Stage I-III, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy * Estrogen and/or progesterone receptor-negative or positive * Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms * Willing to avoid taking any product containing Trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study. * Adequate organ function within 14 days of study enrollment including the following: * Adequate bone marrow reserve: White blood cells (WBC) ≥ 2,000/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL * Hepatic: Bilirubin ≤ 20% times upper limit of normal (ULN), Alkaline phosphatase ≤ 20% times ULN, AST and ALT ≤ 20% times ULN * Renal: Creatinine ≤ 20% times ULN * Nutritional status: Albumin ≥ 3.0 g/dL * Negative pregnancy test * Voluntary written consent before performance of any study-related procedure not part of the normal medical care Exclusion Criteria: * Pregnant - Patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of Trametes versicolor. * Known allergy to fungi, including mushrooms * Serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study * Receipt of hematopoietic growth factors (e.g., Neupogen™, Epogen™) within the previous 4 weeks * Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies * Unwilling to discontinue excluded medications and supplements
References
Publications (0)
Data not yet available
No reference posted for this study.