Clinical trial · Interventional
Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer
A Randomized, Double Blind, Pacebo-Controlled Study to Assess The Feasibility, Toxicity And Efficacy (Phase I/II) Of A Chinese Herbal Therapy (CHT) For Symptom Management In Women Undergoing Chemotherapy For Stage I/II/III Breast Cancer
- 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: Herbs used in traditional Chinese medicine may decrease the side effects of chemotherapy. PURPOSE: Randomized phase I/II trial to study the effectiveness of herbs used in traditional Chinese medicine in decreasing the side effects of chemotherapy after surgery in women who have stage I, stage II, or early stage III breast cancer.
Conditions
Conditions (2)
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 |
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| Chinese herbs | Dietary Supplement | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage I, II, or early stage III breast cancer for which adjuvant doxorubicin and cyclophosphamide is recommended * No metastatic disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Over 18 Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin at least 9.0 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST no greater than 2 times normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No evidence of acute ischemic cardiac disease on ECG Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of multiple severe food or medicine allergies or sensitivities * No medical or psychological condition that would preclude study participation * No severe concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy Radiotherapy: * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * At least 3 weeks since prior investigational agents * At least 3 weeks since prior herbal therapy * No other concurrent investigational agents * No other concurrent herbal therapy or alternative medicine * Concurrent acupuncture allowed
References
Publications (0)
Data not yet available