Does add-on therapy with Chinese herb medicine Bo-Er-Ning capsule (BENC) improve the outcomes of gastric cancer patients?

ISRCTN ISRCTN17186893
DOI https://doi.org/10.1186/ISRCTN17186893
Secondary identifying numbers 2-3-84
Submission date
09/03/2018
Registration date
24/03/2018
Last edited
17/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Jie He
Scientific

Zhangqiu People's Hospital of Shandong
Jinan
250200
China

Study information

Study designSingle-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEvaluation of the adjuvant therapeutic efficacy of Bo-Er-Ning capsule (BENC) in advanced gastric cancer patients by a randomized clinical trial
Study objectivesThe addition of BENC to chemotherapy is better than chemotherapy alone.
Ethics approval(s)Ethics board of Zhangqiu People's Hospital of Shandong, 04/03/2008, ref: ZQH/2008/03-1
Health condition(s) or problem(s) studiedAdvanced gastric cancer
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Tegafur, cisplatin, Bo-Er-Ning capsule
Primary outcome measureMeasured 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 measures3-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 study start date01/01/2008
Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsTrial group: 60; control group: 60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment15/03/2008
Date of final enrolment15/09/2008

Locations

Countries of recruitment

  • China

Study participating centre

Zhangqiu People's Hospital of Shandong
250200
China

Sponsor information

Zhangqiu People's Hospital of Shandong
Hospital/treatment centre

1920 Huiquan Road
Zhangqiu District
Jinan
250200
China

ROR logo "ROR" https://ror.org/00fts7a69

Funders

Funder type

Hospital/treatment centre

Zhangqiu People's Hospital of Shandong

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available to protect the privacy of the patients.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2018 Yes No

Editorial Notes

17/01/2019: Publication reference added.