NCT01287286

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

February 8, 2011

Status Verified

January 1, 2011

Enrollment Period

10 months

First QC Date

January 30, 2011

Last Update Submit

February 6, 2011

Conditions

NeoplasmFunctional Gastrointestinal Disorder

Keywords

CancersAntrodia cinnamomeaChemotherapyGastrointestinal Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Life quality estimates of 10% improvement than control group.

    3 months

Study Arms (2)

AC-Can

EXPERIMENTAL

Antrodia cinnamomea and concomitant chemotherapy

Dietary Supplement: AC-Can

control

PLACEBO COMPARATOR

Placebo and concomitant chemotherapy

Dietary Supplement: placebo

Interventions

AC-CanDIETARY_SUPPLEMENT

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

Also known as: AC
AC-Can
placeboDIETARY_SUPPLEMENT

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

control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Niaosong, Kaohsiung, 83301, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27565426DERIVED

MeSH Terms

Conditions

NeoplasmsGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Yu-Chiang Hung, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsien-Hsueh E Chiu, MD

CONTACT

+887-7-7317123elley@adm.cgmh.org.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2011

First Posted

February 1, 2011

Study Start

June 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2012

Last Updated

February 8, 2011

Record last verified: 2011-01

Locations

TW(1)