Clinical trial NCT01287286: Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy
Official title: Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy- a Double Blinded, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Neoplasm
Functional Gastrointestinal Disorder
Keywords: Cancers
Antrodia cinnamomea
Chemotherapy
Gastrointestinal Disorder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: New Bellus Enterprises
First posted: 2011-02-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could minimize the gastrointestinal symptom of cancer patients with chemotherapy.

Detailed description: In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and hemoglobin increase after 2 months; liver glutamic pyruvic transaminase(GPT) index mitigation, P \<0.05 difference statistically; In addition, liver glutamate oxaloacetate transaminase(GOT) and biochemical index of renal function had no abnormal data statistically. However, cancer patients with gastrointestinal disorders after chemotherapy is known to be a common side effect, we seek to investigate if Antrodia Cinnamomea improves the function of gastrointestinal system.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy.
timeFrame: 1 month
Secondary outcomes:
measure: Life quality estimates of 10% improvement than control group.
timeFrame: 3 months
Other outcomes:
Locations:
city: Niaosong
country: Taiwan
facility: Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center
state: Kaohsiung
Study officials:
affiliation: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center
name: Yu-Chiang Hung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.