Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

Phase 2

• Conditions: Neoplasm; Functional Gastrointestinal Disorder
• Interventions: Dietary Supplement: placebo; Dietary Supplement: AC-Can

• Registration Number: NCT01287286
• Lead Sponsor: Chang Gung Memorial Hospital

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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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

Study Timeline

• Study Start: 2010-06
• Status Verified: 2011-01
• Study First Submitted: 2011-01-30
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-01
• Last Update Submitted: 2011-02-06
• Last Update Posted: 2011-02-08
• Primary Completion: 2011-04
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control	placebo	Placebo and concomitant chemotherapy
AC-Can	AC-Can	Antrodia cinnamomea and concomitant chemotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Life quality estimates of 10% improvement than control group.	3 months	Life science related questionnairs visit 4 times just before treatment, after intervention 7 days, 30 days and 90 days.

Trial Locations

Locations (1)

Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center; 🇨🇳 Niaosong, Kaohsiung, Taiwan