Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

February 6, 2011 updated by: Chang Gung Memorial Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Kaohsiung
      • Niaosong, Kaohsiung, Taiwan, 83301
        • Recruiting
        • Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hsien-Hsueh E Chiu, MD
        • Sub-Investigator:
          • Kun-Ming Rau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AC-Can
Antrodia cinnamomea and concomitant chemotherapy
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
PLACEBO_COMPARATOR: control
Placebo and concomitant chemotherapy
Dietary supplement: placebo
Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy.
Time Frame: 1 month
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.
Time Frame: 3 months
Life science related questionnairs visit 4 times just before treatment, after intervention 7 days, 30 days and 90 days.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

New Bellus Enterprises

Investigators

  • Principal Investigator: Yu-Chiang Hung, MD, PhD, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

January 30, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (ESTIMATE)

February 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2011

Last Update Submitted That Met QC Criteria

February 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMRPG890251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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