Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy
NCT ID: NCT01287286
Last Updated: 2011-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2010-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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AC-Can
Antrodia cinnamomea and concomitant chemotherapy
AC-Can
Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
control
Placebo and concomitant chemotherapy
placebo
Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
Interventions
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AC-Can
Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
placebo
Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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New Bellus Enterprises
UNKNOWN
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital- Kaohsiung Medical Center
Principal Investigators
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Yu-Chiang Hung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center
Locations
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Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center
Niaosong, Kaohsiung, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Tsai 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.
Other Identifiers
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XMRPG890251
Identifier Type: -
Identifier Source: org_study_id
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