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Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

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ClinicalTrials.gov Identifier: NCT01287286
Recruitment Status : Unknown
Verified January 2011 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 1, 2011
Last Update Posted : February 8, 2011
Sponsor:
Collaborator:
New Bellus Enterprises
Information provided by:
Chang Gung Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasm Functional Gastrointestinal Disorder Dietary Supplement: AC-Can Dietary Supplement: placebo Phase 2 Phase 3

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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy— a Double Blinded, Randomized, Placebo-controlled Trial
Study Start Date : June 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : May 2012
Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287286


Contacts
Contact: Hsien-Hsueh E Chiu, MD +887-7-7317123 ext 2332 elley@adm.cgmh.org.tw

Locations
Taiwan
Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center Recruiting
Niaosong, Kaohsiung, Taiwan, 83301
Contact: Pey-Harn Ywi-Chi, Bachelor    +886-7-7317123 ext 2332    kangta614@hotmail.com   
Contact: Kun-Ming Rau, MD    +886-7-7317123 ext 8303    kmrau58@adm.cgmh.org.tw   
Sub-Investigator: Hsien-Hsueh E Chiu, MD         
Sub-Investigator: Kun-Ming Rau, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
New Bellus Enterprises
Investigators
Principal Investigator: Yu-Chiang Hung, MD, PhD Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yu-Chiang Hung / MD, PhD, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital- Kaohsiung Medical Center
ClinicalTrials.gov Identifier: NCT01287286     History of Changes
Other Study ID Numbers: XMRPG890251
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: January 2011

Keywords provided by Chang Gung Memorial Hospital:
Cancers
Antrodia cinnamomea
Chemotherapy
Gastrointestinal Disorder

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases