Condition category
Cancer
Date applied
20/11/2009
Date assigned
18/02/2010
Last edited
18/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Phase II

Drug names

Benzydamine

Primary outcome measures

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 trial start date

10/06/2009

Overall trial end date

10/04/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes