Status unknownNCT01287286Updated Feb 8, 2011

Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

A Phase 2/3 interventional study of AC-Can and placebo in Neoplasm and Functional Gastrointestinal Disorder, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-02-08.

Sponsored by Chang Gung Memorial Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2011), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

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

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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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

Conditions studied

Neoplasm
Functional Gastrointestinal Disorder

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Keywords

Cancers
Antrodia cinnamomea
Chemotherapy
Gastrointestinal Disorder

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 129 are open to participants now.

This study's planned enrollment of 64 is below the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 64 participants (estimated)

Study arms

Experimental
AC-Can
Antrodia cinnamomea and concomitant chemotherapy
Dietary Supplement: AC-Can
Placebo comparator
control
Placebo and concomitant chemotherapy
Dietary Supplement: placebo

Interventions

Dietary supplementAC-Can
Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
Also known as: AC
Dietary supplementplacebo
Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days

What researchers measure

Primary outcomes

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.
Time frame: 1 month

Secondary outcomes

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.
Time frame: 3 months

Study locations

1 of 1 sites recruiting

Division of Haematology and Oncology, Department of Internal Medicine and Traditional Chinese Medicine, Chang Gung Memorial Hospital - Kaohsiung Medical Center
Niaosong, Kaohsiung 83301, Taiwan
- Pey-Harn Ywi-Chi, Bachelor · Contact · kangta614@hotmail.com · +886-7-7317123
- Kun-Ming Rau, MD · Contact · kmrau58@adm.cgmh.org.tw · +886-7-7317123
- Hsien-Hsueh E Chiu, MD · Sub investigator
- Kun-Ming Rau, MD · Sub investigator
Recruiting

References and documents

Publications

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. PubMed 27565426 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01287286
Lead sponsor: Chang Gung Memorial Hospital
Collaborators: New Bellus Enterprises
First posted: Feb 1, 2011
Start date: Jun 2010
Primary completion: Apr 2011 (estimated)
Completion: May 2012 (estimated)
Last update: Feb 8, 2011

Study contacts

Hsien-Hsueh E Chiu, MD

Contact

elley@adm.cgmh.org.tw

+887-7-7317123 ext. 2332

Yu-Chiang Hung, MD, PhD

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

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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