Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

Study Overview
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Brief Summary
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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
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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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.

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

Conditions
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Neoplasm, Functional Gastrointestinal Disorder

Intervention / Treatment
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* Dietary Supplement: AC-Can
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC-Can<br>Antrodia cinnamomea and concomitant chemotherapy | Dietary Supplement: AC-Can<br>* Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days<br>* Other names: AC;|
| Placebo Comparator: control<br>Placebo and concomitant chemotherapy | Dietary Supplement: placebo<br>* Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy. | Post-chemotherapy nausea, vomiting and epigastragia, etc. including gastrointestinal symptom/sign without mention above. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality estimates of 10% improvement than control group. | Life science related questionnairs visit 4 times just before treatment, after intervention 7 days, 30 days and 90 days. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancers, Antrodia cinnamomea, Chemotherapy, Gastrointestinal Disorder