Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: granulocyte-colony stimulating factor (G-CSF): G-CSf will be administered daily on days of radiation therapy at 2 ug/kg dose subcutaneously
Control Intervention1: N/A: N/A
Sponsors
VMMC and Safdarjung hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients having age more than 18 years, and are histologically proven case of squamous cell carcinoma of head and neck with ECOG performance status of 0-2. Patients who have received a radiation dose of 10Gy to head and neck area during current chemo-radiotherapy treatment.
Exclusion criteria
Exclusion criteria: Patients with recurrent or metastatic disease or second primary. Prior irradiation to head and neck area. History of anaphylaxis to G-CSF injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To ascertain the efficacy of granulocyte-colony stimulating factor (G-CSF) by studying the incidence of grade III/IV oral mucositis, using RTOG criteriaTimepoint: weekly during the course of radiation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the time of onset & duration for healing of grade III & IV oral mucositis.Timepoint: Weekly during the course of radiation therapy | — |
Countries
India
Contacts
Public ContactDEVAL GUPTA
VMMC AND Safdarjung hospital
Outcome results
None listed