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Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

Primary Purpose

Neoplasm, Functional Gastrointestinal Disorder

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

AC-Can

placebo

About this trial

This is an interventional treatment trial for Neoplasm focused on measuring Cancers, Antrodia cinnamomea, Chemotherapy, Gastrointestinal Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AC-Can

control

Arm Description

Antrodia cinnamomea and concomitant chemotherapy

Placebo and concomitant chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01287286

First Posted

January 30, 2011

Last Updated

February 6, 2011

Sponsor

Chang Gung Memorial Hospital

Collaborators

New Bellus Enterprises

1. Study Identification

Unique Protocol Identification Number

NCT01287286

Brief Title

Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chang Gung Memorial Hospital

Collaborators

New Bellus Enterprises

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm, Functional Gastrointestinal Disorder

Keywords

Cancers, Antrodia cinnamomea, Chemotherapy, Gastrointestinal Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AC-Can

Arm Type

Experimental

Arm Description

Antrodia cinnamomea and concomitant chemotherapy

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

Placebo and concomitant chemotherapy

Intervention Type

Dietary Supplement

Intervention Name(s)

AC-Can

Other Intervention Name(s)

Intervention Description

Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

Primary Outcome Measure Information:

Title

Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy.

Description

Post-chemotherapy nausea, vomiting and epigastragia, etc. including gastrointestinal symptom/sign without mention above.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Life quality estimates of 10% improvement than control group.

Description

Life science related questionnairs visit 4 times just before treatment, after intervention 7 days, 30 days and 90 days.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hsien-Hsueh E Chiu, MD

Phone

+887-7-7317123

Ext

2332

elley@adm.cgmh.org.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-Chiang Hung, MD, PhD

Organizational Affiliation

Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center

City

Niaosong

State/Province

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pey-Harn Ywi-Chi, Bachelor

Phone

+886-7-7317123

Ext

2332

kangta614@hotmail.com

First Name & Middle Initial & Last Name & Degree

Kun-Ming Rau, MD

Phone

+886-7-7317123

Ext

8303

kmrau58@adm.cgmh.org.tw

First Name & Middle Initial & Last Name & Degree

Hsien-Hsueh E Chiu, MD

First Name & Middle Initial & Last Name & Degree

Kun-Ming Rau, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

27565426

Citation

Tsai MY, Hung YC, Chen YH, Chen YH, Huang YC, Kao CW, Su YL, Chiu HH, Rau KM. A preliminary randomised controlled study of short-term Antrodia cinnamomea treatment combined with chemotherapy for patients with advanced cancer. BMC Complement Altern Med. 2016 Aug 26;16(1):322. doi: 10.1186/s12906-016-1312-9.

Results Reference

derived

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Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

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