Health Condition 1: C140- Malignant neoplasm of pharynx, unspecified
Conditions
Interventions
Intervention1: Metronidazole: Oral Metronidazole as an Adjunct to Concurrent Chemoradiation in Head and Neck Squamous Cell Carcinoma 400 mg bid/tds along with radiation to see if it leads to less radi
Sponsors
Goa Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: age more than 18 years with adequate organ functions and histopathological proof of malignancy undergoing chemoradiation giving written consent
Exclusion criteria
Exclusion criteria: metastatic or recurrent disease, known hypersensitivity to metronidazole or nitroimidazole compounds, pre existing peripheral neuropathy more than grade 2, uncontrolled comorbid illness, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the locoregional response rate following concurrent chemoradiation with and without oral metronidazole in patients with head and neck squamous cell carcinoma.Timepoint: patient will be clinically examined at baseline, weekly during treatment for 6 weeks to look for side effects. loco regional response assessment will be done on completion at 6 weeks by clinical examination. imaging to confirm response via RECISTS1.1 criteria will be done at 8-12 weeks of completion of chemoradiation to allow for mucositis and skin reaction to settle and get clear response as per standard guidelines. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess and compare acute and late treatment-related toxicities in both armsTimepoint: weekly during treatment and at completion .;To evaluate treatment compliance with the addition of oral metronidazoleTimepoint: secondary outcomes measures will be done at baseline for comparison, weekly for 6 weeks during treatment, at treatment completion at 6 weeks, then monthly for 6 months. | — |
Countries
India
Contacts
Public ContactDr Himanshi Joon
Goa Medical College and Hospital
Outcome results
None listed