A study of oral mucositis, pain, xerostomia and quality of life in patients with oral cavity and oropharyngeal cancers undergoing radiotherapy

AIM AND OBJECTIVES

AIM: To study the acute toxicities such as pain, mucositis  and late sequelae of radiotherapy such as xerostomia in patients receiving concurrent chemo radiotherapy in Head and Neck cancer and also to assess quality of life in same patients.

OBJECTIVES:

PRIMARY OBJECTIVE:

To assess the toxicities in patients of head and neck cancer undergoing radiotherapy (i pain, ii.oral mucositis, iii. Xerostomia.)

SECONDARY OBJECTIVE:

To assess the quality of life.

SAMPLE SIZE:

The calculated sample size is 67.

INCLUSION AND EXCLUSION CRITERIA

INCLUSION CRITERIA:

·   1. Carcinoma of head and neck including oral cavity, oropharynx undergoing IMRT, VMAT and concurrent chemotherapy .

·     2. Patients of age group between 18-65 yrs.

·     3. Patient with ECOG 0-2.

·   4. Patients willing to sign an informed consent.

EXCLUSION CRITERIA:

·     1. Patients with  previous history of radiation to head and neck.

·      2. Patients with known distant metastasis.

·      3. Patients with ECOG 3-4

4. 4. Pregnant women and lactating mothers

PATIENT EVALUATION:

All patients will be  evaluated before RT ,weekly during the course of treatment  and monthly for 3 months after radiotherapy for the acute toxicities(mucositis, pain, xerostomia, quality of life) and 6 months for late toxicities (xerostomia , quality of life).

Assessment of pain will be done by using Visual Analogue Scale.

Assessment of mucositis and xerostomia and grading will be done according to RTOG-Early and Late Radiation Morbidity scoring scheme.

Assessment of Quality of life using EORTC QLQ H&N 35 Questionnaire.

Follow up of the patients was advised monthly for 3 months and 2 monthly for 6 months.

STATISTICAL ANALYSIS:

Data will be collected in the study proforma , entered in Microsoft Excel(Windows 11;Version 2021)and analyses will be done using the Statistical Package for Social Sciences(SPSS)for Windows software (version 26.0;SPSS Inc, Chicago) .Continuous variables will be presented in the form of mean, standard deviation, range, and categorical data will be presented in the form of number and percentage. Chi-Square test or Fischers  exact test  will be used for qualitative parameters. Student’s t-test will be used for quantitative variables. P value  <0.05 will be considered statistically significant