Plain English Summary
Background and study aims
Bo-Er-Ning capsule (BENC) is a traditional Chinese medicine derived from natural products. It is composed of a series of key pharmaceutical ingredients, including Radix Astragali, Fructus Ligustri Lucidi, Tulipaedulis, Herba Portulacae, Rhizoma Paridis , Solanum Nigrum, Fructus Perillae, Corium Stomachichum galli, Rhubarb, Borneol and Bombyx Batryticatus. The aim of this study is to assess the effect of BENC on gastric (stomach) cancer patients.
Who can participate?
Patients aged 25 to 75 with gastric cancer
What does the study involve?
Participants are randomly allocated into two groups: the trial group and the control group. The trial group receive BENC accompanying tegafur and cisplatin drug treatment, while the control group receive tegafur and cisplatin only. Both groups are assessed after three cycles of treatment (each cycle involves 14 days of treatment and 7 days of rest).
What are the possible benefits and risks of participating?
Patients from the trial group may have a better quality of life, such as better appetite and body weight gain, and improved overall survival. As a typical Chinese herb medicine, BENC has been used as an additional medicine for other types of cancer, and no side effects have been reported.
Where is the study run from?
Zhangqiu People's Hospital of Shandong (China)
When is the study starting and how long is it expected to run for?
January 2008 to June 2012
Who is funding the study?
Zhangqiu People's Hospital of Shandong (China)
Who is the main contact?
Prof. Jie He
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2-3-84
Study information
Scientific title
Evaluation of the adjuvant therapeutic efficacy of Bo-Er-Ning capsule (BENC) in advanced gastric cancer patients by a randomized clinical trial
Acronym
Study hypothesis
The addition of BENC to chemotherapy is better than chemotherapy alone.
Ethics approval
Ethics board of Zhangqiu People's Hospital of Shandong, 04/03/2008, ref: ZQH/2008/03-1
Study design
Single-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Advanced gastric cancer
Intervention
All patients with advanced GC treated by FP regimen (Tegafur + Cisplatin) in Zhangqiu People's Hospital of Shandong were enrolled for this clinical study by a doctor participating in the study and randomly divided into two groups by another doctor. Among those, 58 patients received BENC accompanying FP regimen (trial group), while 54 patients received FP regimen alone (control group).
Treatment regimen for control group: Tegafur 40~60mg, oral administration, two times a day, from day 1 to day 14 and Cisplatin 40mg, intravenous infusion administration, from day 1 to day 3.
Treatment regimen for trial group: BENC 4 capsules, taken orally three times a day (with warm water half an hour after a meal) for 14 days (from day 1 to day 14), accompanying Tegafur and Cisplatin treatment (the same drug dosage and usage as the control group).
Both groups were evaluated after 3 cycles (both groups take 21 days as one cycle) of chemotherapy (14 days of treatment and 7 days of rest).
Intervention type
Drug
Phase
Not Applicable
Drug names
Tegafur, cisplatin, Bo-Er-Ning capsule
Primary outcome measures
Measured at week 9 (after 3 cycles of chemotherapy):
1. Appetite, assessed by filling out answer sheets
2. Karnofsky performance score (KPS), assessed by filling out answer sheets
3. Body weight, measured using a weight scale
Secondary outcome measures
3-year overall survival: patients followed up by clinic visit, phone, or mail at least once every 6 months starting from day 1 after the treatment
Overall trial start date
01/01/2008
Overall trial end date
30/06/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age from 25 to 75 years
2. All patients were pathologically confirmed for stage IV or postoperative recurrence and metastasis GC
3. Karnofsky performance score (KPS) ≥ 80
4. No previous anticancer therapy
5. No dysfunction of heart, liver, lung and kidney
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Trial group: 60; control group: 60
Participant exclusion criteria
1. Age<25 and >75 years
2. Patients were not pathologically confirmed for stage IV or postoperative recurrence and metastasis GC
3. Karnofsky performance score (KPS) < 80
4. Possess previous anticancer therapy
5. Possess dysfunction of heart, liver, lung and kidney
Recruitment start date
15/03/2008
Recruitment end date
15/09/2008
Locations
Countries of recruitment
China
Trial participating centre
Zhangqiu People's Hospital of Shandong
250200
Funders
Funder type
Hospital/treatment centre
Funder name
Zhangqiu People's Hospital of Shandong
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available to protect the privacy of the patients.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary