Malignant neoplasm of head, face and neck. Malignant neoplasm of head, face and neck
Conditions
Interventions
Intervention 1: Silymarin group: Patients Swish mouth with 15 ml of 0.2% silymarin solution (Silybum marianum extract, Zardband pharmaceuticals, Tehran, Iran) every 8 hours for two minutes and spit th
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years old Any ECOG performance status Head and neck cancer patient Any setting of radiation (i.e. definitive, neoadjuvant, adjuvant) Receiving at least 50 Gy radiation to 2 out of 4 subsite of the head and neck, including oral cavity, Oropharynx, hypopharynx, and the larynx More than 2 cm of irradiated mucosal surface in any head and neck subsite
Exclusion criteria
Exclusion criteria: History of severe allergy to silymarin, benzydamine or other NSAIDs Narcotic use in the last month (even once) History of radiation therapy to the same target areas Presence of mucositis on admission History of dry mouth Proven dementia or history of uncontrolled psychiatric disease Pregnancy Malnutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 3 mucositis. Timepoint: Before intervention and every week after intervention for at least 5 weeks. Method of measurement: According to CTCAE v.5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade 1 and 2 mucositis. Timepoint: before intervention and every week during intervention for at least 5 weeks. Method of measurement: According to CTCAE v.5.;Grade 3 and 4 mucositis. Timepoint: before intervention and every week during intervention for at least 5 weeks. Method of measurement: According to CTCAE v.5.;Mucositis onset. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: The day of the first evidence of grade 1 mucositis detected by history or examination from the day of treatment initiation - according to CTCAE v.5.;Tube or Intravenous nutrition. Timepoint: Before intervention and every week during intervention for at least 5 weeks. Method of measurement: History and examination.;Opioid Use. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: Any opioid use detected by subjectively.;Hospitalization. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: Subjective - Inquired.;Mucositis recovery time. Timepoint: Every week during intervention for at least 5 weeks, and the two post-intervention weeks. Method of measurement: The day mucositis score reaches zero from treatment termination - according to CTCAE v5.0.;Mortality. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: Subjective - Inquired.;Overall survival. Timepoint: The duration of survival after 24 months (730 days) from the moment of randomization. Method of measurement: Subjective - Inquired. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDavoud Jahansouz
Babol University of Medical Sciences
Outcome results
None listed