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Evaluation of silymarin solution efficacy on prevention of radiotherapy induced mucositis

Evaluation of silymarin 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
IRCT20241014063364N1
Enrollment
40
Registered
2024-11-18
Start date
2024-09-22
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Head and neck cancers. Malignant neoplasm of nasopharynx

Interventions

Intervention 1: Intervention group:Patients in the intervention group will be treated with a Silymarin solution (20 drops of the Silymarin solution from Zardband company, four times a day). The medica

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 years old Karnofsky Performance Status (KPS) 70 or more than 70 (or ECOG=0-1) New case There is pathologic diagnosis on head and neck malignancies There is indication of adjuvant or definitive radiation therapy Minimum treatment dose of 60 GY At least half of oral cavity should be in the treatment field

Exclusion criteria

Exclusion criteria: Dissatisfication of patient for enter to the study Chronic renal ( eGFR3 upper limit of normal) disease History of previous malignancy History of previous radiation therapy on head and neck area History of hypersensitivity reaction to sylimarin Patient recieve induction chemotherapy

Design outcomes

Primary

MeasureTime frame
Grading of mucositis. Timepoint: The first fraction of radiotherapy, weekly during radiation therapy until two months after finishing the treatment. Method of measurement: World Health Organization grading system for mucositis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyede Simin Mirmohammadi Kiarash

Shiraz University of Medical Sciences

km.silverian@yahoo.com+98 13 4252 0356

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026