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Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy— a Double Blinded, Randomized, Placebo-controlled Trial

Phase 2/Phase 3
18 Years
80 Years
Open (Enrolling)
Neoplasm, Functional Gastrointestinal Disorder

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Trial Information

Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy— a Double Blinded, Randomized, Placebo-controlled Trial

In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy.

Outcome Description:

Post-chemotherapy nausea, vomiting and epigastragia, etc. including gastrointestinal symptom/sign without mention above.

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Yu-Chiang Hung, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center


Taiwan: Department of Health

Study ID:




Start Date:

June 2010

Completion Date:

May 2012

Related Keywords:

  • Neoplasm
  • Functional Gastrointestinal Disorder
  • Cancers
  • Antrodia cinnamomea
  • Chemotherapy
  • Gastrointestinal Disorder
  • Neoplasms
  • Digestive System Diseases
  • Gastrointestinal Diseases