Types of Head and neck cancers treated with radiotherapy. ????? ??? ????? ??? ???? ???? ? ??????
Conditions
Interventions
Intervention group: Patients taking Alpha lipoic acid capsules 300 mg, one capsule twice a day for 6 to 8 weeks, and the control group: patients taking placebo with the same form and method of adminis
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Histologically confirmed head and neck cancer stage I II III or non-metastatic IV No distant metastasis Planned radiotherapy with a total dose of 60 Gy or more with or without concomitant chemotherapy regimen of Cisplatin (100 mg/m2 every 21 days for 3 cycles or 40 mg/m2 every week for 7 cycles) Adequate baseline liver function (liver enzyme levels 60ml/min) Adequate baseline bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 platelets count > 100,000 cells/mm3) Have adequate baseline salivary function. ECOG performance status 0-1
Exclusion criteria
Exclusion criteria: Previous head and neck radiotherapy Previous sensitivity to Alpha lipoic acid Having active autoimmune diseases that affect the salivary glands, such as Sjogren's Diabetes or recent use of Alpha lipoic acid Having another malignant tumor Thyroid disease Excessive alcohol consumption Salivary gland cancers Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining the protective effect of Alpha lipoic acid on the incidence and severity of oral mucositis induced by radiotherapy in patients with head and neck cancers. Timepoint: At the beginning of the study (before the intervention) and once a week for up to 2 weeks after the end of treatment. Method of measurement: Comparison of average WHO Oral Mucositis Grading Scale scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination and comparison of the mean score of the Visual Analogue Scale for dry mouth each week during treatment until two weeks after completion of radiotherapy in the two intervention and control groups. Timepoint: At the beginning of the study (before the start of the intervention) and once a week for up to 2 weeks after the end of treatment. Method of measurement: Visual Analogue Scale.;Determining and comparing the average VAS pain intensity score each week during treatment until two weeks after completion of radiotherapy in the two intervention and control groups. Timepoint: At the beginning of the study (before the start of the intervention) and once a week for up to 2 weeks after the end of treatment. Method of measurement: Visual Analogue Scale.;Determining and comparing the mean quality of life score before radiotherapy, during treatment, and after radiotherapy in the two intervention and control groups. Timepoint: At the beginning of the study (before the intervention), mid-treatment (week 3 or 4), and end of treatment. Method of measurement: EORTC-QLQ-H&N35 questionnaire.;Determination and comparison of Salivary Flow Rate before radiotherapy, during treatment, and after radiotherapy in the two intervention and control groups. Timepoint: At the beginning of the study (before the intervention), mid-treatment (week 3 or 4), and end of treatment. Method of measurement: Collect unstimulated saliva in a graduated container for 5 minutes. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Sadeghi
Esfahan University of Medical Sciences
Outcome results
None listed