Trial | NCT01287286  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    64
The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could minimize the gastrointestinal symptom of cancer patients with chemotherapy.
In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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.
Study Started
Jun 30
2010
Primary Completion
Apr 30
2011
Anticipated
Study Completion
May 31
2012
Anticipated
Last Update
Feb 08
2011
Estimate

Dietary Supplement AC-Can

Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

  • Other names: AC

Dietary Supplement placebo

Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

AC-Can Experimental

Antrodia cinnamomea and concomitant chemotherapy

control Placebo Comparator

Placebo and concomitant chemotherapy

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
No Results Posted