Sleep, a fundamental element of health, accounts for about one-third of our lives, and is as crucial as nutrition and exercise. Among university students, medical students are one subset that seems particularly susceptible to sleep problems, perhaps due to the length and complexity of their studies and being under a high level of stress. Yoga Nidra has been studied as a therapeutic intervention for various medical conditions. The aim of the study is to evaluate the efficacy of short-duration Yoga Nidra for improving sleep quality in students at a tertiary healthcare centre in Rishikesh, Uttarakhand.

A two-group parallel randomised controlled trial will be conducted among undergraduate medical students with a Pittsburgh Sleep Quality Index (PSQI) score >5. Efficacy of short-duration Yoga Nidra in comparison to sleep education will be evaluated for PSQI scores, heart rate variability, respiratory rate, pulse rate, body mass index, blood pressure, random blood sugar, lipid profile, interleukin 6, salivary cortisol, generalised anxiety disorder and depressive disorder. The intervention will be pre-recorded with the duration of 12 min. The intervention group participants will receive three sessions per week for 4 weeks. The sample size is 160 students. All analyses will follow the intention-to-treat approach using SPSS V.26. Descriptive statistics, test of associations, parametric and/or non-parametric methods (as appropriate) will be used to assess within and between group changes.

The Institutional Ethics Committee (All India Institute of Medical Sciences (AIIMS), Rishikesh) has approved the study (#AIIMS/ie,C/22/231) and the trial has been prospectively registered in Clinical Trials Registry-India: CTRI/2022/07/044426. The results will be published in a peer-reviewed journal.

CTRI/2022/07/044426.

Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2–N3).

The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).

The study population consists of patients with operable OSCC and advanced nodal disease (N2–N3), adequate organ function, aged 18–65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.

This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies.

CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).