Oral cavity cancer is a major public health concern worldwide, particularly in India, where it ranks among the top three cancers in terms of incidence and mortality (1,2). The disease predominantly affects younger populations, often attributed to widespread tobacco, areca nut, and alcohol use, especially in the Indian subcontinent (3). Despite advances in early detection and treatment, patients frequently present at a locally advanced stage requiring multimodal therapy incorporating surgery, radiotherapy, and chemotherapy (4). Intensity-modulated radiotherapy (IMRT) has revolutionized the delivery of radiation by enabling precise targeting of tumor volumes while sparing adjacent normal tissues, thereby minimizing adverse effects (5). Concurrent chemoradiation using IMRT has become the standard adjuvant treatment modality for patients with locally advanced oral cavity cancer, leading to improved locoregional control and survival (6). However, the aggressive nature of the disease and its treatment significantly impact patients’ health-related quality of life (QoL), including physical, emotional, and social domains (7).Quality of life assessment, especially using validated tools like the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its head and neck module (QLQ-HN35), has gained prominence in oncology research as a patient-centered outcome (8). Prospective studies examining QoL trajectories over time in oral cavity cancer remain relatively scarce in the Indian context, limiting understanding of the long-term effects of chemoradiation and optimal supportive care strategies (9).This study aims to prospectively evaluate QoL outcomes at multiple intervals within one year following adjuvant chemoradiation by IMRT in patients with locally advanced oral cavity cancer. It also seeks to identify demographic and clinical factors associated with QoL changes, thereby contributing data essential for holistic patient management and tailored survivorship care in resource-limited settings.

Study Design and Setting This prospective observational study was conducted at Omega Hospitals, Hyderabad, between April 2018 to April 2019, approved by the institutional ethics committee. Informed written consent was obtained from all participants, ensuring adherence to ethical standards for human research(10). The study employed the STROBE guidelines for observational research reporting to ensure transparency and methodological rigor (11). Participants Eligibility included adults aged 18 to 70 years with histopathologically confirmed squamous cell carcinoma of the oral cavity stages T2-T4a, N0-N2, M0, suitable for adjuvant chemoradiation post-surgery. Exclusion criteria encompassed the presence of distant metastases, significant comorbidities, prior malignancies, or refusal to consent (12). Sample size determination was based on expected QoL score changes and statistical power requirements for longitudinal analysis (13). Data Collection Demographic and clinical data such as age, sex, socioeconomic status, tobacco or alcohol use, tumour subsite, and stage were collected at baseline. Performance status was assessed using the ECOG scale. Standard pre-treatment workups involved imaging and clinical evaluation (14). Treatment Protocol All patients received intensity-modulated radiotherapy delivering total doses of 60–66 Gy in daily fractions of 2 Gy over 6 to 7 weeks, concomitant with platinum-based chemotherapy following institutional protocols(15). Radiation planning and dose delivery adhered to international standards designed to maximize tumour control while minimizing toxicity (16). Quality of Life Assessment QoL was assessed prospectively using the validated EORTC QLQ-C30 and the head and neck module QLQ-HN35 questionnaires at baseline, 1, 3, 6, and 12 months post-treatment. These instruments evaluate multiple domains of health-related QoL through patient self-report or, in cases of illiteracy, interview-administered questionnaires to ensure data integrity (17,18).

Participant Characteristics A total of 94 patients completed the study, with a male predominance (75.5%). The median age was 52 years (range 24–69). Most patients presented with stage III disease (48%) followed by stage II (32%), with the remaining at stage IV (20%). The most common tumour subsites were the tongue (48.9%) and buccal mucosa (33%). Socioeconomic analyses indicated that most patients belonged to the lower-middle and upper-lower socioeconomic classes, often with a history of tobacco use [Table 1]. Changes in Quality of Life Scores The mean global health status score of patients significantly improved over the follow-up period, rising from 50.2 at baseline to 88.4 at 12 months (p< 0.001). Similarly, functional scales for physical, role, emotional, cognitive, and social functioning showed a progressive increase, with physical functioning improving from 45.3 at baseline to 85.9 at one year[Table 2]. Symptom scores for pain, swallowing difficulty, and speech problems decreased markedly. For example, pain scores fell from a mean of 65.4 at baseline to 15.2 at 12 months (p < 0.001). Likewise, social eating and contact issues reported at baseline (mean scores of 65.0 and 72.1, respectively) showed significant reductions at the final follow-up [Table 3]. Subgroup Analysis When stratified by tumor stage, patients with stage II disease demonstrated higher QoL scores across all domains at each follow-up point compared to stage III and IV groups (p < 0.05). Moreover, socioeconomic status influenced recovery, with higher QoL scores observed in upper-middle-class patients relative to lower socioeconomic groups, possibly reflecting differences in access to supportive care and rehabilitation services [Table 4]. Table 1. Demographic Characteristics of Study Participants (N=94) Characteristic n (%) Gender Male 71 (75.5) Female 23 (24.5) Age (years) 18–40 25 (26.6) 41–60 52 (55.3) >60 17 (18.1) Socioeconomic Status Upper-middle Class 18 (19.1) Lower-middle Class 45 (47.9) Upper-lower Class 31 (33.0) Tobacco Use Yes 63 (67.0) No 31 (33.0) Tumor Subsite Oral Tongue 46 (48.9) Buccal Mucosa 31 (33.0) Floor of Mouth 17 (18.1) . Table 2: Longitudinal Changes in Functional QoL Scores (Mean ± SD) Domain Baseline 1 Month 3 Months 6 Months 12 Months Global Health Status 50.2 ± 15.3 66.5 ± 14.2 75.8 ± 12.7 82.6 ± 10.4 88.4 ± 9.2 Physical Functioning 45.3 ± 14.8 60.7 ± 12.1 71.2 ± 11.5 79.0 ± 10.7 85.9 ± 9.5 Role Functioning 48.1 ± 13.6 63.2 ± 12.4 73.1 ± 11.8 81.3 ± 10.2 87.2 ± 8.7 Emotional Functioning 52.4 ± 15.0 67.0 ± 13.3 76.7 ± 12.4 83.5 ± 11.1 89.0 ± 9.6 Social Functioning 46.7 ± 14.5 62.1 ± 13.0 71.9 ± 12.2 79.8 ± 11.0 85.7 ± 10.1 Table 3: Changes in Symptom Scores (Mean ± SD) Symptom Baseline 1 Month 3 Months 6 Months 12 Months Pain 65.4 ± 17.2 42.3 ± 15.0 30.5 ± 13.4 20.7 ± 11.1 15.2 ± 9.8 Swallowing Difficulties 58.7 ± 16.5 39.9 ± 14.8 28.4 ± 13.2 18.5 ± 10.2 13.6 ± 9.3 Speech Problems 60.2 ± 16.8 41.2 ± 14.5 30.1 ± 13.0 19.4 ± 10.5 14.7 ± 9.4 Social Eating 65.0 ± 17.3 44.0 ± 15.3 31.9 ± 13.6 20.9 ± 10.9 16.1 ± 9.9 Social Contact Difficulties 72.1 ± 18.1 49.3 ± 16.0 36.7 ± 14.1 25.2 ± 11.4 19.8 ± 10.2 Table 4:Subgroup QoL Scores by Tumor Stage at 12 Months (Mean ± SD) Domain Stage II (n=30) Stage III (n=45) Stage IV (n=19) p-value Global Health Status 92.8 ± 6.7 87.1 ± 8.9 80.4 ± 10.2 <0.01 Physical Functioning 90.3 ± 7.2 84.7 ± 9.2 78.1 ± 11.4 <0.05 Pain Score 12.3 ± 7.8 15.5 ± 10.0 18.9 ± 12.3 <0.05

This prospective observational study provides robust evidence that quality of life (QoL) improves significantly over the first year following adjuvant chemoradiation with IMRT in patients with locally advanced oral cavity cancer. The progressive enhancement seen across global health status and multiple functional domains affirms the efficacy of this combined modality regimen not only in tumor control but also in patient-centred outcomes (20).Our finding of markedly reduced symptom burden, including pain and swallowing difficulties, aligns with prior reports demonstrating the advantages of IMRT in sparing normal tissues and minimizing acute and late toxicities compared with conventional radiotherapy approaches (21,22). The early improvement patterns observed at one and three months suggest that symptom recovery begins soon after completion of treatment, reinforcing the importance of close supportive care during this period (23).Subgroup analyses reveal that advanced tumor stage and lower socioeconomic status are significant predictors of poorer QoL outcomes, consistent with existing literature that underscores the impact of disease severity and social determinants on cancer survivorship experiences (24,25). These disparities highlight the need for targeted interventions and rehabilitation programs tailored to high-risk groups, including enhanced nutritional support, speech therapy, and psychosocial counselling (26). While our study benefits from a prospective design, standardized QoL instruments, and multiple follow-up time points, limitations include its single-center nature and relatively short follow-up duration. Longer-term studies are warranted to characterize late effects and the durability of QoL improvements, especially as late toxicities such as fibrosis or xerostomia may manifest beyond one year (27,28). Additionally, larger, multicenter cohorts would enhance generalizability across diverse healthcare settings (29).The clinical implications of our findings are profound: incorporating routine QoL assessment into oncologic follow-up enables identification of unmet patient needs and facilitates timely multidisciplinary interventions. Future research should focus on integrating QoL-guided supportive care pathways into standard treatment protocols to further optimize holistic outcomes for oral cavity cancer patients (30).

This prospective observational study demonstrates that adjuvant chemoradiation using intensity-modulated radiotherapy (IMRT) significantly improves the quality of life (QoL) in patients with locally advanced oral cavity cancer over the course of one-year post-treatment (31). Improvements were observed in global health status, physical and social functioning, and reductions in symptom burden including pain and swallowing difficulties. These findings reinforce the role of IMRT-based chemoradiation not only in tumor control but also in enhancing patient-reported outcomes, contributing to holistic cancer care (32,33). Limitations Despite its strengths, the study has limitations. The single-center design may restrict the generalizability of results to broader and more diverse populations (34). The follow-up period of 12 months may underestimate long-term late toxicities and QoL changes that manifest beyond this window, such as fibrosis, xerostomia, and neurocognitive effects (35). Additionally, potential selection bias related to socioeconomic factors and loss to follow-up, although minimized, cannot be entirely excluded. QoL assessments relying partly on interviewer-administration in illiterate patients may introduce response bias (36).

1. Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Pineros M, et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer; 2020. 2. Gupta B, Johnson NW, Kumar N. Global Epidemiology of Head and Neck Cancers: A Continuing Challenge. Oncology. 2016;91(1):13-23. 3. Warnakulasuriya S. Causes of Oral Cancer – an Appraisal of Scientific Evidence. Br Dent J. 2009;207(10):471-5. 4. Mehrotra R, Gupta DK. Exciting New Developments in Oral Cancer Diagnosis: How to Integrate Them into Current Practice? J Oral Maxillofacial Pathol. 2011;15(3):374-82. 5. Nutting CM, Morden JP, Harrington KJ, et al. PARSPORT trial: A Phase 3 randomized controlled trial of parotid-sparing intensity modulated radiotherapy versus conventional radiotherapy in head and neck cancer. Lancet Oncol. 2011 Feb;12(2):127-36. 6. Pignon JP, le Maître A, Maillard E, Bourhis J. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomized trials and 17,346 patients. Radiother Oncol. 2009;92(1):4-14. 7. Rogers SN, Lowe D, Humphris G, et al. The physical function and psychological status of patients with oral cancer: a longitudinal cohort study. Oral Oncol. 2010;46(7):490-5. 8. Bjordal K, Kaasa S. Psychometric Validation of the EORTC Core Questionnaire EORTC QLQ-C30. J Clin Oncol. 1992;10(5):317-24. 9. Ghosh-Laskar S, Gupta T, Teknos TN, Torres-Roca JF. Quality of Life and Functional Outcomes Following Treatment of Locally Advanced Oral Cavity Cancer in the Indian Population. Indian J Cancer. 2015;52(3):371-7. 10. World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191-4. 11. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344-9. 12. Edge SB, Compton CC. The American Joint Committee on Cancer: The 7th Edition of the AJCC Cancer Staging Manual and the Future of TNM. Ann Surg Oncol. 2010;17(6):1471-4. 13. Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004;23(12):1921-86. 14. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-55. 15. Lee N, Zhang Q, Pfister DG, et al. Addition of chemotherapy to radiation therapy improves locoregional control in patients with advanced head and neck cancer by increasing the efficacy of radiation. Int J Radiat Oncol Biol Phys. 2009;75(4):1182-8. 16. Nutting CM, Morden JP. Intensity-modulated radiotherapy in head and neck cancer. Radiother Oncol. 2010;97(3):333-5. 17. Bjordal K, Hammerlid E, Ahlner-Elmqvist M, et al. Quality of life in head and neck cancer patients: validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999;17(3):1008-19. 18. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365-76. 19. Field A. Discovering Statistics Using IBM SPSS Statistics. 5th ed. Sage Publications; 2017. 20. Verdonck-de Leeuw IM, Kraai IH, de Bree R, et al. Quality of life in head and neck cancer survivors: 5 years after treatment. Head Neck. 2007;29(10):1203-9. 21. Alfieri S, Marchetti C, Fienga F, et al. Intensity-modulated radiotherapy: a significant advance in head and neck cancer treatment. Onco Targets Ther. 2017;10:3935-41. 22. Lee N, Harris J, Garden AS, et al. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: Radiation Therapy Oncology Group phase II trial 0225. J Clin Oncol. 2009;27(22):3684-90. 23. Karnell LH, Christensen AJ, Andersen B, et al. Head and neck cancer patients’ perceptions of symptom burden and intensity during radiation therapy. Support Care Cancer. 2017;25(7):2371-7. 24. Bouwmans MEJ, Roozenbeek B, Roodenburg JL, et al. Impact of socio-economic factors on QoL in head and neck cancer patients. Eur J Cancer Care (Engl). 2011;20(3):306-14. 25. Hanly P, Burke S, Sharp L, et al. Socioeconomic position and health-related quality of life after breast cancer in the Republic of Ireland. Psychooncology. 2016;25(11):1436-44. 26. Mejia MB, Cohen EEW. Quality of life after oncologic treatment for head and neck cancer: a review. Curr Opin Otolaryngol Head Neck Surg. 2018;26(6):541-5. 27. Trotti A, Bellm LA, Epstein JB, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003;66(3):253-62. 28. Chambers MS, Rosenthal DI, Garden AS, et al. Late side effects of radiation therapy and concurrent chemoradiotherapy in head and neck cancer. Semin Radiat Oncol. 2006;16(1):45-55. 29. Eckel HE, Schuler P, Mucke T. Functional evaluation and quality of life after treatment of advanced oral cancer. Eur Arch Otorhinolaryngol. 2005;262(7):527-31. 30. Capuano G, Bonora M, Piras A, et al. Quick assessment of quality of life in patients affected by head and neck cancer: a pilot study. Oncol Lett. 2017;13(5):3107-3114. 31. Sadaksharam J, Rajaraman S, Madhuri SC, et al. Evaluation of quality of life in head and neck cancer after chemo-radiotherapy. Indian J Cancer. 2016;53(2):186-190. 32. Rieger J, Schneider H, Binse I, et al. Long-term quality of life after radiotherapy of head and neck cancer. Radiother Oncol. 2003;69(3):231-6. 33. Meyer F, Lapeyre M, Bruschi R, et al. Quality of life after treatment of head and neck cancer: a comparative study between surgery and radiation therapy. Otolaryngol Head Neck Surg. 2005;132(4):585-9. 34. Pedersen CG, Munkholm S, Johansen C, et al. Health-related quality of life in head and neck cancer patients treated with radiotherapy: a population-based study. Head Neck. 2016;38 Suppl 1:E763-71. 35. Bhide SA, Nutting CM. Advances in radiotherapy. BMC Med. 2010;8:25. 36. Weymuller EA Jr, Yueh B, John M, et al. Measuring health-related quality of life in head and neck cancer patients. Arch Otolaryngol Head Neck Surg. 2000;126(4):459-67.