Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Neoplasm; Functional Gastrointestinal Disorder

Treatments: Dietary Supplement: AC-Can; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01287286

XMRPG890251

Details and patient eligibility

About

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

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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

AC-Can

Experimental group

Description:

Antrodia cinnamomea and concomitant chemotherapy

Treatment:

Dietary Supplement: AC-Can

control

Placebo Comparator group

Description:

Placebo and concomitant chemotherapy

Treatment:

Dietary Supplement: placebo