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 |
| Protocol serial number | N/A |
| Sponsor | Imam Hossein Hospital (Iran) |
| Funder | Imam Hossein Hospital (Iran) |
- 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
Scientific
Imam Hossein Hospital
Department of Radiation Oncology
Shahid Madani St
Tehran
1617763141
Iran
| Phone | +98 (0)21 7755 2056 |
|---|---|
| A_Ameri@sbmu.ac.ir |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Benzydamine versus placebo in radiation-induced mucositis in patients with head and neck cancer: a phase II randomised controlled trial |
| Study acronym | Gorgani II |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Benzydamine |
| Primary outcome measure(s) |
Reducing mucositis, measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy) |
| Key secondary outcome measure(s) |
1. Time to grade III mucositis |
| Completion date | 10/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/06/2009 |
| Date of final enrolment | 10/04/2010 |
Locations
Countries of recruitment
- Iran
Study participating centre
Imam Hossein Hospital
Tehran
1617763141
Iran
1617763141
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
