exercise therapy during radiotherapy to improve quality of life in head and neck cancer.
Not yet recruiting
- Conditions
- Malignant neoplasms of lip, oral cavity and pharynx,
- Registration Number
- CTRI/2023/01/049171
- Lead Sponsor
- SOUMYAJIT MANDAL
- Brief Summary
Ethical approval of this study was taken from theinstitutional Ethical Committee of Maharishi Markandeshwar (Deemed to beUniversity), Mullana,(MMDU/IEC/2227). It will be done by Helsinki declarationrevised in 2013 and National Ethical Guidelines for Biomedical Researchinvolving Human participants, 2017. Difficulty in mouthopening is a common problem in patients with Head Neck Cancer(HNC). There aretherapeutic interventions for HNC. This study has been planned to evaluate theeffect of exercise therapy during ongoing radiotherapy to improve mouth openingand quality of life in patients with HNC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Participants are willing to participate.
- Histologically proven Squamous Cell Carcinoma of oral cavity, oropharynx, hypopharynx, and larynx.
- Stage II-IV by AJCC Cancer Staging Manual Eighth Edition, 2017.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or less.
- Age group between 18 to 70 years.
Exclusion Criteria
- Any Pre- existing diagnosed neurological condition.
- History of pervious Radiotherapy to the head and neck region.
- Initial mouth opening less than 10mm.
- patients taking any physiotherapy or speech therapy treatment for trismus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mouth Opening measure by Digital vernier caliper. At baseline and after 4 week
- Secondary Outcome Measures
Name Time Method quality of life measure by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35) At baseline and after 4 week
Trial Locations
- Locations (1)
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
🇮🇳Ambala, HARYANA, India
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation🇮🇳Ambala, HARYANA, IndiaSOUMYAJIT MANDALPrincipal investigator9091943875soumyajitmandal2204@gmail.com