Effect Of Granulocyte Colony Stimulating Factor Administration On Chemoradiation Induced Mucositis In Locally Advanced Head And Neck Cancer Patients – A Prospective Randomized Study

Here is a detailed 500-word summary of the thesis:

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Summary: Effect of G-CSF Administration on Chemoradiation-Induced Mucositis in Locally Advanced Head and Neck Cancer PatientsBackground and Rationale

This thesis protocol, submitted to Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, investigates the role of Granulocyte Colony Stimulating Factor (G-CSF) in managing one of the most debilitating side effects of cancer treatment — oral mucositis. Head and neck cancer is the seventh most common cancer globally, representing 26.2% of new cancer cases according to GLOBOCAN 2022. The standard treatment for locally advanced Head and Neck Squamous Cell Carcinoma (HNSCC) is concurrent chemoradiotherapy (CCRT), which, while effective for local tumor control, inevitably causes significant mucosal toxicity.

Oral mucositis — inflammation of the oral mucosa ranging from redness to severe ulceration — is a common and painful complication of CCRT. It can cause excruciating pain, necessitate parenteral nutrition, increase infection risk, lead to septicemia, and cause unscheduled treatment breaks that compromise outcomes. G-CSF (specifically Filgrastim) promotes neutrophil production and modulates the inflammatory environment, potentially aiding mucosal healing by increasing anti-inflammatory cytokines and reducing pro-inflammatory mediators like TNF-alpha.

Aim and Objectives

The primary aim of the study is to evaluate the effect of weekend G-CSF administration on the incidence and severity of oral mucositis in head and neck cancer patients receiving concurrent chemoradiotherapy with three-weekly cisplatin. The secondary objective is to compare tumor response between the G-CSF group and the control group at 3 months post-treatment using RECIST criteria.

Study Design and Methodology

This is a single-center, prospective, randomized interventional study to be conducted over 18 months in the Department of Radiation Oncology at SVIMS, Tirupati, following Institutional Ethics Committee (IEC) approval and CTRI registration. A total of 44 patients (22 per arm) aged 18–70 years with histopathologically proven Stage III–IV non-metastatic HNSCC and ECOG performance status 0–1 will be enrolled. Patients are randomized into a study group (CCRT + weekend G-CSF) and a control group (CCRT alone).

All patients receive radiation therapy using IMRT or VMAT techniques and concurrent cisplatin at 100 mg/m² every three weeks for two cycles. Patients in the study arm receive subcutaneous G-CSF (Filgrastim) at 150 mcg/day every Saturday throughout the treatment (6–7 weekends), maintaining a 24-hour gap from radiotherapy. Mucositis is assessed weekly using the RTOG Acute Radiation Toxicity Grading Scale, and tumor response is assessed at 3 months via contrast-enhanced CT of the head and neck.

Literature Context

Several prior studies have explored GM-CSF and G-CSF for mucositis prevention. A key Indian study (Prathyusha et al., 2019) on 75 patients showed that weekend Filgrastim significantly reduced mucositis severity, with a mean mucositis score of 1.33 in the study group versus 1.62 in controls, and better treatment compliance. The current study builds on this evidence.

Statistical Analysis

Data will be analyzed using SPSS v26.0. Continuous variables will be compared using unpaired t-tests or Mann-Whitney U tests, and categorical variables using chi-square or Fisher’s exact tests. A p-value < 0.05 is considered statistically significant.

Significance

This study addresses a critical unmet need in supportive oncology care — reducing treatment-limiting toxicity in head and neck cancer patients through a cost-effective, weekend-only G-CSF schedule, potentially improving both patient quality of life and treatment completion rates.