Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01287286
• Other study ID #: XMRPG890251
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 30, 2011
• Last updated: February 6, 2011
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: January 2011
• Source: Chang Gung Memorial Hospital
• Contact: Hsien-Hsueh E Chiu, MD
• Phone: +887-7-7317123
• Email: elley[@]adm.cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorder
• Gastrointestinal Diseases
• Neoplasm

Intervention

Dietary Supplement:
• AC-Can
Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
• placebo
Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

Locations

Country	Name	City	State
Taiwan	Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center	Niaosong	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	New Bellus Enterprises

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No