Thesis & Dissertation
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Item Comparison of two fluoride application regime in oral cancer patients a randomized controlled trial(SRHU, 2022-11-29) Kandwal, AbhishekIntroduction: Oral cancer ranks first among males and second overall in the Indian population as per GLOBOCAN 2020. In these patients Supportive oral care lack as an integrated part of cancer care. The most prevalent side effect of chemoradiotherapy (CT-RT) is Radiation caries and their sequel. This results in increased dental disease burden and poor oral health-related quality of life scores (OHRQOL). Aim: Present Randomized controlled trial was conducted to evaluate the effect of fluoride on dental disease burden in terms of DMFT scores in patients who have received CT-RT in the region of the oral cavity. Oral health-related quality of life in terms of OHIP-14 scores was also assessed. Materials& Methods: 111 patients participated in the randomized controlled trial as per the CONSORT statement. Two regimens, Monthly, and quarterly application were further divided into varnish and gel subgroups. This resulted in a total of four groups including monthly varnish application (AV), monthly gel application (AG), quarterly varnish application (BV), and quarterly gel application (BG). These were analyzed for DMFT and OHIP-14 scores at baseline, one month, six months, and one-year recall post chemo-radiotherapy (CT-RT). Results: Median and Interquartile range of DMFT scores for the AV group were 2(0.25-6), 2(1-6), 3(1-7.7), and 4(1-9) at baseline, one month, six months and one xviii year recall respectively. For the AG group, it was 2(1-5), 2(1-5), 4(1-8), and 5(1-8) respectively. For BV Group it was 3(1-4), 3(1-4), 3(2-6), and 4(2-6) respectively, while for BG Group it was 2(0-4), 2(0-4), 391.5-4.5) and 4(2-5) respectively for four recall points. These values were highly significant P<0.001. OHIP-14 score’s Median and Interquartile range at baseline, one month, six months, and one year recall were 14(11-25.7), 35(28.2-40), 5.5(0-6) respectively. For AG group it was 13(2-24), 29(26-36), 6(0-12) and 0(0-6) respectively. For BV group it was 15(10-24), 34(27-46), 3(0-14) and 0(0-7) respectively. While For BG it was 11(5-18.5) 29(23.5-40), 3(0-11) and 0(0-6.5) respectively. These values were highly significant with P<0.001. Intergroup comparison was not significant for DMFT and OHIP-14 scores for four intervention groups. OHIP-14 score’s Mean and standard deviation values for sufficient mouth opening and insufficient mouth opening were 20.6 ±9.5 and 12.8 ±9.8 respectively, which was highly significant with p <0.001. Conclusion: DMFT scores reported a significant and minimal constant increase in patients at one-year recall from baseline. Fluoride application was effective in controlling the DMFT scores at one-year recall in these patients. OHIP-14 scores significantly improved at recall visits from baseline by use of fluoride as part of the Supportive Oral Care Protocol (SOCP). Fluoride varnish and gel applied either monthly or quarterly provided similar changes in DMFT and OHIP-14 scores. Hence any combination of these can be considered effective in the care of these patients. Insufficient mouth opening drastically reduces oral health-related quality of life scores in these patients and hence they required more care. xix Clinical Recommendation: Fluoride application as per supportive oral care protocol (SOCP) is recommended as an integral part of the oral care needs of head and neck cancer patients including oral carcinoma. Monthly topical fluoride application during the first year post CT-RT and thereafter-quarterly application lifelong is advised. Involvement of a Dental supportive care expert from the point of diagnosis of cancer is needed. A Dental expert as a part of the multidisciplinary team for cancer care of head and neck cancer patients is recommended.Item Prognostic significance of nutrition and immunity in head and neck cancer- a prospective observational study(SRHU, 2023-09-01) Arora, AnshikaBackground: In developing countries, HNSCC differs from Western world in terms of age at presentation, subsite of disease, etiology (more tobacco and alcohol related), higher malnutrition and molecular biology. Certain special challenges are faced by developing countries like illiteracy, poverty, lack of awareness, advanced stage of cancer, limited access to specialized health care, and limited treatment infrastructure create difficulties in management of cancer patients. To improve the survival in clinical practice, simple and low cost indices predicting a raised risk for poor clinical outcome, in terms of recurrent disease, distant metastasis or mortality, are required in HNSCC patients. There is need for alow cost model to predict prognosis in Indian patients, specially tailored to the needs of a lowermiddle- income country. Aims and Objectives: i. To study the nutritional profile and systemic immunity in patients with HNSCC. ii. To study the correlation between the nutritional status and systemic immunity with outcome of treatment in patients being treated for HNSCC. iii. To develop a low cost model for early prognosis using nutritional status and systemic immunity marker in patients being treated for HNSCC. Materials and Methods: This was a prospective cohort study, conducted at Cancer Research Institute, Swami Rama Himalayan University,Dehradun. The patients starting treatment for HNSCC were enrolled in the study after a written informed consent, they were evaluated for nutrition status (using anthropometric methods and Subjective Global Assessment score) and systemic immunity (using peripheral blood neutrophil/lymphocyte ratio), before starting, during, and at completion of planned treatment. The disease status and overall survival were assessed upto 6 months of completion of planned treatment. The primary end points of the study were Nutritional status and Systemic Immunity before and xxxiii after treatment, and disease status and overall survival at 6 months of completion of treatment. Statistical Analysis: MS Excel 2010 was used for data entry, SPSS software version 22 was used for statistical analysis. Parametric and non-parametric tests were used for association and correlation analysis. “Cochran's and Mantel-Haenszel Statistic” were used to calculate Risk Ratio (RR). Multivariate analysis was performed using the Multi-nominal Logistic Regression model. ROCs were generated to get cut-off values and their sensitivity and specificity to predict the outcome. Survival curves were generated using Kaplan- Meiermethod and Cox-Regression model, and were used to calculate the Hazard Ratio (HR) for outcomes i.e., the Progression Free Survival (PFS) and Overall Survival (OS). Using the RR and ROC cut-off values of variables that were significantly associated with the outcome, novel Risk Stratification models were developed to predict outcomes- failure to complete planned treatment, disease recurrence 6months and death at 6 months. Results: Malnutrition (defined as either ≥10% weight loss or BMI <18.5, or SGA score ≥40) was found in 47.1% patients pre-treatment and this proportion increased to 87.6% patients post-treatment. The median neutrophil tolymphocyteratio (NLR) IQR was 3 (2-4) pretreatment and increased to 5 (3.8-8.4) post-treatment. There was statistically significant moderate positive correlation between NLR and SGA score, pre-treatment percent weight loss and a moderate negative correlation between NLR, weight and BMI. Malnutrition was significantly associated with failure to complete planned treatment in node positive patients and raised NLR in node negative patients. On multivariate analysis, Cox-Regression and Survival Analysis with Kaplan-Meier curves, both poor nutritional status and raised NLR, were associated with poor six months progression free and overall survival. Conclusion: The H0 hypothesis (there is no correlation between nutritional status and systemic immunity in patients with Head and Neck Squamous Cell Carcinoma) is rejected and the alternate H1 hypothesis (there is a positive correlation between nutritional status and systemic immunity in patients with Head and Neck Squamous Cell Carcinoma) is accepted. xxxiv The novel low cost risk stratification models, developed in this study using clinical parameters, nutritional status and the NLR were successfully tested for internal validation as predictive for poor clinical response (failure to complete planned treatment, early disease recurrence and mortality) in patients being treated for HNSCC. Clinical Recommendations: i. Apart from the regular clinical and disease parameters (like PS, clinical stage, pathological features, subsite etc.) patients’ baseline nutritional status and systemic immunity marker, NLR, should be taken into account while planning the oncological management for HNSCC patients. ii. A patient with malnutrition at the start of oncological treatment for HNSCC should be offered structured nutritional advice and regular nutritional monitoring during the ongoing active treatment to improve clinical outcomes of these patients. iii. Systemic immunity marker, NLR, as calculated from the peripheral blood sample, is a cost effective and easily available tool and should be utilized routinely to prognosticate HNSCC patients planned for treatment into high risk groups for poor clinical outcomes. iv. The novel low cost risk stratification models developed in this study were validated internally to prognosticate patients as low, medium, and high risk, for poor clinical outcomes, and now need to be validated externally on different HNSCC patient populations by other researchers.Item Dosimetric evaluation in carcinoma lung by intraluminal brachytherapy and correlation in phantom model(SRHU, 2024-10-01) Kant, RaviIn the carcinoma lung patient, endobronchial brachytherapy (EBBT) is used as treatment modality. The radiation dose to the tumor is planned in the treatment planning system (TPS) on the CT scan of the patient and treatment delivered by the machine. Treatment plan verification, dosimetric, volumetric analysis is necessary to perform for accurate treatment delivery to the patient, which requires a tissue equivalent phantom model mimicking the actual thoracic body structure because in the actual patient, dosimetry is not possible. In this study, the dosimetric analysis is performed in the locally fabricated human tissue equivalent thorax phantom with the help of Radiochromic film dosimeters. Dosimetric and volumetric analysis is performed on patients treated with EBBT technique.