1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  drdharmapoonia@gmail.com


6. For how long will this data be available start date provided 01-07-2023 and end date provided 01-07-2026?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Cancer is growing in incidence and has become a significant health concern across the globe. Head and Neck Cancer is one of the common cancer in India, and the majority of them present in the advanced stage. Standard treatment for such patients includes surgery with radiotherapy. This extended treatment provides the cure, but treatment-related adverse events and lack of treatment tolerance lead to inferior quality of life, and physical and psychological ill-health, including chronic fatigue, pain, neck & shoulder stiffness, anxiety, and sleeplessness. Yoga is an alternative form of therapy, which has the potential to enhance the coping ability to receive complete treatment and help to curtail various treatment-related adverse events. 

Yoga is an ancient mind-body interventional known more than 5000 years back. It helps shift the attention of physical attributes to make a person aware of self by activating the interoceptive neural network, hence having the potential to improve well-being. Yoga has been used extensively to deal with chronic symptoms. Yoga has been found effective in improving the physical and psychological well-being of various cancer, including breast and colorectal cancer. The data showing the utility of yoga in head and neck cancer is limited. The study by Adair et al. showed yoga’s feasibility and preliminary efficacy in head and neck cancer patients. Based on the existing data and yoga has the potential to improve musculoskeletal impairment. 

The current study is a randomized controlled trial, where we intended to find out the benefit of yoga therapy. Yoga therapy starts at the onset of oncological treatment to the 24 weeks of the post-treatment period. To ensure adherence to the yoga protocol, we will teach yoga therapy to the caregiver in yoga sessions. Videotaped audio video and printed material will be provided. Weekly feedback during home-based yoga will be recorded using the mobile application. The experimental arm will receive standardized yoga therapy for a defined period. We will measure the quality of life, physical symptoms, psychological well-being, and the blood level of inflammatory markers at predefined intervals using the defined methodology. We will further analyze the adverse events of yoga and implemental barriers also. This would be a phase III study with a strong level of evidence, and positive results would establish yoga as an adjunct treatment to the oncological treatment of head and neck cancer. 

Objectives- 
1. To study the quality of life after adding yoga therapy in the head and neck cancer patients managed with surgery first curative intent treatment.
2. To study physical- Psychological well-being.
3. To determine the serial change in the level of inflammatory markers.
4. To systematically map the adverse events and assess the implementation barriers and self-sustainability.

Trial Design is Single blinded, Randomized, Controlled Trial; Parallel design with 1:1 allocation into Control and Yoga Groups (CG vs. YG). Stratified randomization will be done based on - sub-site (Buccal mucosa vs. Tongue), stage of the disease (stage I-III vs. Stage IV), type of reconstruction (locoregional flap vs. free flap), and type of adjuvant therapy. 
Participants- study setting: Study will be conducted in the oncology department (surgical & Radiation) and AYUSH, AIIMS Jodhpur. All consecutive patients with HNC between the age of 18-70 years, planned for curative-intent treatment with initial surgery with or without adjuvant treatment, will be assessed for inclusion in the study. Patients with recurrent disease, metastatic disease, and second primary will be excluded. Patients’ general fitness for yoga asana & breathing exercises will be assessed before randomization.
Interventions: 

Once the patient consents to take part in the trial he will randomize into one of the study groups, either CG or YG. The CG will receive standard treatment care as per the institution’s protocol. The YG will receive care as described during the whole length of treatment and same will be continued for 3 months post treatment. A standardized yoga protocol (Annexure-1) including postures (Asana) and breath control (Pranayama) practice will be administered. The session will include session of 45-60 min, 3 days per week. To improve the adherence, one of the consented and motivated primary caregivers will be trained for Yoga exercises. He/she will be present regularly during the course of treatment. One session in a week will be taken online. Videotaped materials for home will be provided to each participants. Patient or care giver will give weekly feedback during home based yoga practices.

Outcome Assessment timing- 
Baseline, Before adjuvant therapy, Completion of adjuvant therapy, 3 & 6 months post-treatment Outcome measures- 
● Quality of life: EORTC QLQ-C30 & QLQ-H&N35)
● Patient-reported outcomes to measure the physical and psychological well-being: Neck Dissection Impairment Index, Pittsburgh Sleep Quality Index, Chalder Fatigue Questionnaire, and Depression, Anxiety, Stress Score
● Assessment of objective assessment of physical function: Cervical- shoulder range of motion and Timed Up and test
● Plasma levels of markers i.e. IL 6, IL8, TNF-α and CRP levels will be estimated by Enzyme-linked immunosorbent assay
● Adherence and barrier of implementation will be recorded qualitatively
● Adverse events (B-E) using Common Terminology Criteria for Adverse Events.