Clinical trial NCT01503346: DaHuang GangTsao Tang to Improve the Appetite Loss Condition of Cancer Patients
Official title: Taking Herbal Formula：DaHuang GangTsao Tang to Improve the Appetite Loss Condition of Cancer Patients in Late-stage：A Clinical Control Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-organic Loss of Appetite
Keywords: Appetite Loss
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Appetite loss is a severe and common symptom among late-stage cancer patients, and it causes great the anxiety for the patient's family. In TCM theory, the investigators call these patients are in block and repulsion condition. The investigators try to set a study to use the herbal medicine solution taken in frequent small amounts by cancer patients in late-stage to improve the appetite loss condition. Through this method, the investigators not only want to improve the quality of life of cancer patients in late-stage but also set a valuable treatment.

Detailed description: Intervention group

* 1. 2 grams of DaHuang abstract powder and 0.5 grams GanTsao abstract powder are mixed and separated into four packages;
* 2. each package was given to each patient four times a day (three time after meal and one time before sleep);
* 3. each patient received the usual medication of the hospice ward at the same time;
* 4. record the patients' score of pre-test, mid-test and after-test of QIPCTP at the 1st day, the 3rd day and the 6th day;
* 5. record the patients' score of EORTC QLQ-C30 V3.0 and ECOG (Eastern Cooperative Oncology Group Performance Status) at the 1st day and the 6th day.

Control group

* 1. each patient received the usual medication of the hospice ward during the trial interval;
* 2. record the patients' score of receive pre-test, mid-test and after-test of QIPCTP at the 1st day, the 3rd day and the 6th day;
* 3. record the patients' score of EORTC QLQ-C30 V3.0 and ECOG (Eastern Cooperative Oncology Group Performance Status) at at the 1st day and the 6th day.

Medicine DaHuang herbal abstract powder is produced by Sun Ten Pharmaceutical Co., Ltd, and it's product serial number: 276001. GanCao herbal abstract powder is also produced by Sun Ten Pharmaceutical Co., Ltd, and it's product serial number: 185645. Each herbal abstract powder is qualified with the data of HPLC to confirm each content and stability. The pharmaceutical company is qualified by Good Manufacturing Practice (GMP) certification in Taiwan.

Eligibility criteria: Inclusion Criteria:

* Terminal cancer patients in hospice ward
* Patients with appetite loss condition
* Ages between 20 to 80 years old
* No history of diabetes

Exclusion Criteria:

* Entered the stage of dying patients
* Receiving other traditional Chinese medicine

Primary outcomes:
measure: appetite score
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Changhua Christan Hospital
state: Changhua Country
Study officials:
affiliation: Changhua Christian Hospital
name: Yu De LIU, Master
role: STUDY_CHAIR
References: