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Evaluation of dexamethasone solution efficacy on prevention of radiotherapy induced mucositis in patients with head and neck cancer

Evaluation of dexamethasone solution efficacy on prevention of radiotherapy induced mucositis in patients with head and neck cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240525061893N1
Enrollment
50
Registered
2024-07-21
Start date
2021-03-21
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapy-induced mucositis in head and neck patients. Oral mucositis (ulcerative) due to radiation

Interventions

Intervention 1: - Intervention group: Dexamethasone mouthwash (0.5 mg of dexamethasone in 10 ml of normal saline) - 10 cc of the solution is gargled in the mouth four times a day from the day before r

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Performance level of KPS=70 (or ECOG score=0-1) Newly diagnosed patient Having a pathological diagnosis of head and neck cancer Presence of adjuvant or definitive radiotherapy indication The treatment dose is at least 60 Gry Placement of at least half of the oral cavity in the radiotherapy treatment field

Exclusion criteria

Exclusion criteria: Lack of consent to participate in the study Presence of chronic kidney (eGFR three times normal) History of previous malignancy History of previous radiation therapy in the head and neck area History of hypersensitivity reaction to dexamethasone mouthwash

Design outcomes

Primary

MeasureTime frame
Treatment complications based on the checklist designed based on CTCAE v4.0 and the World Health Organization system. Timepoint: Weekly from the beginning of treatment until two months after treatment. Method of measurement: The basis of the checklist designed based on CTCAE v4.0 and the World Health Organization system.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNooshin Dindar

Shiraz University of Medical Sciences

nooshindindar@ymail.com00988431765

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Apr 3, 2026