Comparing benzydamine with placebo in the prevention of radiation-induced mucositis in head and neck cancer patients in Imam Hossein Hospital, Iran

ISRCTN ISRCTN07033239
DOI https://doi.org/10.1186/ISRCTN07033239
Secondary identifying numbers N/A
Submission date
20/11/2009
Registration date
18/02/2010
Last edited
18/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ahmad Ameri
Scientific

Imam Hossein Hospital
Department of Radiation Oncology
Shahid Madani St
Tehran
1617763141
Iran

Phone +98 (0)21 7755 2056
Email A_Ameri@sbmu.ac.ir

Study information

Study designPhase II randomised 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 below to request a patient information sheet
Scientific titleBenzydamine versus placebo in radiation-induced mucositis in patients with head and neck cancer: a phase II randomised controlled trial
Study acronymGorgani II
Study objectivesBenzydamine can prevent radiation-induced mucositis in head and neck cancer patients.
Ethics approval(s)Imam Hossein Hospital, Department of Radiation Oncology Ethics Committee approved on the 10th July 2009 (ref: 122)
Health condition(s) or problem(s) studiedHead and neck cancer/mucositis
InterventionPatients will be randomised in two groups (placebo and benzydamine). Subjects were encouraged to brush their teeth at least twice daily, floss once daily, rinse as necessary with bland oral rinses (e.g., normal saline, sodium bicarbonate). Commercial mouthwashes (over the counter or prescription), chlorhexidine, or other agents to aid in oral hygiene were prohibited.

Oral rinsing with study treatments was initiated the day before RT and continued for 2 weeks after the end of RT. 15 ml for 2 minutes, 4 - 8 times daily before and during RT, and for 2 weeks after completion of RT. If burning or stinging occurred, dilution of the rinse with water at 1:1 or 1:2 was allowed. All bottles of study rinse were returned each week and the amount returned recorded.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Benzydamine
Primary outcome measureReducing mucositis, measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy)
Secondary outcome measures1. Time to grade III mucositis
2. Time to grade IV mucositis
Measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy).
Overall study start date10/06/2009
Completion date10/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50 (25 in each arm)
Key inclusion criteria1. Male and non-pregnant female subjects aged 18 - 80 years
2. Diagnoses of head and neck malignancy
3. Total external beam radiotherapy (RT) dose of at least 5000 cGy via a megavoltage treatment with either a cobalt-60 or a linear accelerator
4. At least two oral mucosal sites included in the planned RT treatment volume
Key exclusion criteria1. Karnofsky performance status less than 80%
2. Hypersensitivity to benzydamine or typical nonsteroidal anti-inflammatory drugs (NSAIDs)
3. Had taken experimental drugs within 30 days of study start
4. Chronically took steroids, NSAIDs, or other analgesics for other medical conditions
Date of first enrolment10/06/2009
Date of final enrolment10/04/2010

Locations

Countries of recruitment

  • Iran

Study participating centre

Imam Hossein Hospital
Tehran
1617763141
Iran

Sponsor information

Imam Hossein Hospital (Iran)
Hospital/treatment centre

Department of Radiation Oncology
Shahid Madani St
Tehran
1617763141
Iran

Email A_Ameri@sbmu.ac.ir
ROR logo "ROR" https://ror.org/053qhtw56

Funders

Funder type

Hospital/treatment centre

Imam Hossein Hospital (Iran)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan