Selenium in radiochemotherapy mucositis

The effect of Selenium on incidence and severity of mucositis in head and neck cancer patients undergoing radio chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014072718612N1

Enrollment

Registered

2016-10-07

Start date

2014-11-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: Malignant melanoma of other and unspecified parts of face. Condition 2: Malignant neoplasm of nasal cavity and middle ear. Condition 3: Malignant neoplasm of accessory sinuses. Condition 4: Malignant neoplasm of larynx. Condition 5: Malignant melanoma of lip. Malignant melanoma of other and unspecified parts of face Malignant neoplasm of nasal cavity and middle ear Malignant neoplasm of accessory sinuses Malignant neoplasm of larynx Malignant melanoma of lip

Interventions

Intervention 1: intervention group: Tab selenium 200 mg twice daily during radiotherapy. Intervention 2: control group: two placebo tablets per day during radiotherapy.

Treatment - Drugs

Placebo

intervention group: Tab selenium 200 mg twice daily during radiotherapy

control group: two placebo tablets per day during radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: inclusion criteria:age over 18 years old;head and neck carcinoma ;radiocemotherapy candidate;liver and kidney normal condition;at least two third of oral cavity is exposed radiotherapy exclusion criteria:under 18 years old;prior history of using selenium;kidney and hepatic failure

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Mucositis. Timepoint: 7days after interventionn and then weekly and 7 days after finshing intervention. Method of measurement: Physical examination.;Selenium blood level. Timepoint: prior of radiation start and at the end of radiotherapy sessions. Method of measurement: Spectrophotometry.;Neutropenia. Timepoint: prior of selenium start and at the end of radiotherapy sessions. Method of measurement: blood level.;Mucositis length. Timepoint: 7days after interventionn and then weekly and 7 days after finshing intervention. Method of measurement: observation.	—

Measure

Time frame

Mucositis. Timepoint: 7days after interventionn and then weekly and 7 days after finshing intervention. Method of measurement: Physical examination.;Selenium blood level. Timepoint: prior of radiation start and at the end of radiotherapy sessions. Method of measurement: Spectrophotometry.;Neutropenia. Timepoint: prior of selenium start and at the end of radiotherapy sessions. Method of measurement: blood level.;Mucositis length. Timepoint: 7days after interventionn and then weekly and 7 days after finshing intervention. Method of measurement: observation.

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Secondary

Measure	Time frame
Npo(non per oral) time. Timepoint: 7 days after intervention and then weekly. Method of measurement: Physical examination.;Narcotic use. Timepoint: weekly. Method of measurement: observation.;Weight. Timepoint: prior and at the end of selenium use. Method of measurement: kg.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElahe Laali

Faculty of Pharmacy

elahe_laali@yahoo.com+98 21 2293 6465

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 17, 2026