Clinical trial · Interventional
Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy
Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy- a Double Blinded, Randomized, Placebo-controlled Trial
NCT01287286CI-TRIAL-00004392unknownPhase 2 / Phase 3ClinicalTrials.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)
The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could minimize the gastrointestinal symptom of cancer patients with chemotherapy.
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 |
|---|---|---|---|
| Functional Gastrointestinal Disorder | — | UNRESOLVED | — |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC-Can | Dietary Supplement | — | UNRESOLVED |
| placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AC-Can
- description
- Antrodia cinnamomea and concomitant chemotherapy
- interventionNames
- Dietary Supplement: AC-Can
- type
- PLACEBO_COMPARATOR
- label
- control
- description
- Placebo and concomitant chemotherapy
- interventionNames
- Dietary Supplement: placebo
Primary outcomes (1)
- measure
- Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy.
- timeFrame
- 1 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed Cancer. * Age ≦ 80 years old and ≧ 18 years old. * Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. * Adequate organ function, including followings Hepatic: Total bilirubin level ≦1.5 x UNL, GOT and GPT ≦ 2.5 x UNL if no liver metastasis; GOT and GPT ≦ 5 x UNL if liver metastasis. Renal: Creatinine level\< 1.5 milligram per deciliter or Estimated creatinine clearance(CCr) ≧ 60 milliliter per minute (CCr is estimated by Cockcroft-Gault formula, as appendix II) * Estimated life expectancy of at least 12 weeks. * Written(signed) Informed Consent * Ever treated and poor tolerance with platinum-based or anthracycline- based regimen, likely nausea and vomiting. Exclusion Criteria: * Prior participation in any investigational drug study within 28 days * Active uncontrolled infections or human immunodeficiency virus(HIV) infection * Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction( 6 months before randomization), chronic obstructive pulmonary disease with frequent exacerbation, chronic renal diseases (estimated CCr 60 milliliter per minute), uncontrolled diabetes, uncontrolled hypertension, recent cerebrovascular disease episode( 6 months before randomization ) * With clinically significant Gastrointestinal disorder (e.g. bleeding, inflammation, obstruction or diarrhea) * Psychiatric disorders that would compromise the patient's compliance or decision. * Pregnancy or breast feeding. * Known hypersensitivity to the component of investigational drugs. * Known or suspected Gilbert's syndrome * Poor compliance
References
Publications (1)
- DERIVEDTsai MY, Hung YC, Chen YH, Chen YH, Huang YC, Kao CW, Su YL, Chiu HH, Rau KM. A preliminary randomised controlled study of short-term Antrodia cinnamomea treatment combined with chemotherapy for patients with advanced cancer. BMC Complement Altern Med. 2016 Aug 26;16(1):322. doi: 10.1186/s12906-016-1312-9. PMID 27565426