Contact information
Type
Scientific
Contact name
Dr Ahmad Ameri
ORCID ID
Contact details
Imam Hossein Hospital
Department of Radiation Oncology
Shahid Madani St
Tehran
1617763141
Iran
+98 (0)21 7755 2056
A_Ameri@sbmu.ac.ir
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Benzydamine versus placebo in radiation-induced mucositis in patients with head and neck cancer: a phase II randomised controlled trial
Acronym
Gorgani II
Study hypothesis
Benzydamine 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)
Study design
Phase II randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Head and neck cancer/mucositis
Intervention
Patients 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 type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Benzydamine
Primary outcome measure
Reducing mucositis, measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy)
Secondary outcome measures
1. 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 date
10/06/2009
Overall study end date
10/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
50 (25 in each arm)
Participant exclusion criteria
1. 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
Recruitment start date
10/06/2009
Recruitment end date
10/04/2010
Locations
Countries of recruitment
Iran
Study participating centre
Imam Hossein Hospital
Tehran
1617763141
Iran
Sponsor information
Organisation
Imam Hossein Hospital (Iran)
Sponsor details
Department of Radiation Oncology
Shahid Madani St
Tehran
1617763141
Iran
A_Ameri@sbmu.ac.ir
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Imam Hossein Hospital (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|