Effect of granulocyte colony stimulating factor (G-CSF) in prevention of radiation induced oral mucositis in patients receiving chemo-radiotherapy for head and neck cancer.
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- VMMC and Safdarjung hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To ascertain the efficacy of granulocyte-colony stimulating factor (G-CSF) by
Overview
Brief Summary
It is an interventional study. Patients will have to give detailed clinical history and undergo clinical examination with evaluation of the primary tumour, nodes and metastasis. Radiation dose will be 66-70 Gy as total dose, with 2Gy in each fraction given over 5 consecutive days. Chemotherapy will be given as weekly intravenous cisplatin (40mg/m2) as per standard protocol. Patients who have received radiation dose of 10 Gy, will be administered 2µg/kg/day subcutaneously of granulocyte-colony stimulating factor (G-CSF) in the unirradiated normal skin daily till the end of radiation therapy. Patients will be assessed with daily clinical examination, to grade oral mucositis using RTOG criteria(8), and weekly blood tests.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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-
- •Patients who have received a radiation dose of 10Gy to head and neck area during current chemo-radiotherapy treatment.
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.
Outcomes
Primary Outcomes
To ascertain the efficacy of granulocyte-colony stimulating factor (G-CSF) by
Time Frame: weekly during the course of radiation therapy
studying the incidence of grade III/IV oral mucositis, using RTOG criteria
Time Frame: weekly during the course of radiation therapy
Secondary Outcomes
- To study the time of onset & duration for healing of grade III & IV oral mucositis.(Weekly during the course of radiation therapy)
Investigators
DEVAL GUPTA
VMMC AND Safdarjung hospital