Functional Gastrointestinal Disorder, Neoplasm
Conditions
Keywords
Cancers, Antrodia cinnamomea, Chemotherapy, Gastrointestinal Disorder
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In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and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.
Interventions
DIETARY_SUPPLEMENTAC-Can
Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
DIETARY_SUPPLEMENTplacebo
Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
Sponsors
New Bellus Enterprises
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy. | 1 month | Post-chemotherapy nausea, vomiting and epigastragia, etc. including gastrointestinal symptom/sign without mention above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life quality estimates of 10% improvement than control group. | 3 months | Life science related questionnairs visit 4 times just before treatment, after intervention 7 days, 30 days and 90 days. |
Countries
Taiwan
Contacts
Primary ContactHsien-Hsueh E Chiu, MD
Outcome results
None listed