Condition category
Cancer
Date applied
09/03/2018
Date assigned
24/03/2018
Last edited
22/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jie He

ORCID ID

Contact details

Zhangqiu People's Hospital of Shandong
Jinan
250200
China

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 measure

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 (if study stopped)

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

Sponsor information

Organisation

Zhangqiu People's Hospital of Shandong

Sponsor details

1920 Huiquan Road
Zhangqiu District
Jinan
250200
China

Sponsor type

Hospital/treatment centre

Website

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes