Assessing the Nutrition and swallowing in patients with upper aerodigestive tract cancers undergoing surgery or radiotherpay

Not yet recruiting

Conditions: Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, (2) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (3) ICD-10 Condition: C329||Malignant neoplasm of larynx, unspecified, (4) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,

Lead Sponsor: Postgraduate institute of Medical Education and Research Chandigarh

Brief Summary: This observational study will be conducted at the Department of Otolaryngology and Head and Neck Surgery of the Post Graduate Institute of Medical Education and Research in Chandigarh, India, from July 2023 to December 2024; it seeks to evaluate the nutritional status, swallowing function, and the influence of pretreatment rehabilitative counselling in patients with upper aerodigestive tract cancers. With a sample size of 80 patients, divided into two groups undergoing surgery or chemo/radiotherapy, the study aims to assess primary outcomes, including nutritional status, swallowing function, and speech intelligibility, while also exploring secondary objectives such as diagnostic and therapeutic delays, posthoc subgroup analyses, and continuous follow-up for up to 24 weeks or beyond. This research aims to provide insights into the challenges faced by these patients and the potential benefits of pretreatment counselling in their overall well-being.

Recruitment & Eligibility

Inclusion Criteria

Adult patients (>18 years) of both genders with biopsy-proven cancers of the upper aerodigestive tract who are consenting for the study.
For Group I: 1.
Adult patients (>18 years) of both genders with biopsy-proven cancers of the upper aerodigestive tract who are consenting to the study and are planning to undergo upfront surgical management.
For Group II: 1.
Adult patients (>18 years) of both genders with biopsy-proven cancers of the upper aerodigestive tract who are consenting to the study and are planning to undergo upfront Radiotherapy/Chemoradiotherapy.

Exclusion Criteria

Endocrine and salivary gland malignancies of the head and neck not involving the upper aerodigestive tract.
Second primary malignancies.
Recurrent disease/Relapse 4.
Uncontrolled co-morbidities limiting the primary management of the disease.
Non-consenting individuals 6.
Patients with a history of prior surgical procedures of the upper aerodigestive tract for any benign or non-tumorous conditions which can impact swallowing and nutritional status of the patient.

Primary Outcome Measures

Name	Time	Method
1. Pre and post-treatment nutritional status in patients of upper aerodigestive tract cancers to understand the impact of treatment on nutrition.	1. Pre-intervention: the patients will be evaluated before 2 weeks of the definitive intervention. \| 2. After the definitive treatment they will undergo post-operative nutritional assessment, swallowing assessment and instrumental assessment with FEES, and speech assessment and swallowing rehabilitation at 6 weeks and 12 weeks. Another follow-up will be done at 24 weeks.
2. Status of swallowing and associated patient-related outcome measures both pre and post-treatment in patients of upper aerodigestive tract cancers.	1. Pre-intervention: the patients will be evaluated before 2 weeks of the definitive intervention. \| 2. After the definitive treatment they will undergo post-operative nutritional assessment, swallowing assessment and instrumental assessment with FEES, and speech assessment and swallowing rehabilitation at 6 weeks and 12 weeks. Another follow-up will be done at 24 weeks.
3. Speech intelligibility in patients of oral cavity cancers.	1. Pre-intervention: the patients will be evaluated before 2 weeks of the definitive intervention. \| 2. After the definitive treatment they will undergo post-operative nutritional assessment, swallowing assessment and instrumental assessment with FEES, and speech assessment and swallowing rehabilitation at 6 weeks and 12 weeks. Another follow-up will be done at 24 weeks.

Secondary Outcome Measures

Name	Time	Method
â€¢Diagnostic and therapeutic delays for patients of upper aerodigestive tract cancers	â€¢Outcomes from post-hoc subgroup analysis of the patients including

Locations (1): PGIMER
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Dr Nivedhan R
Principal investigator
9524649590
nivedhanmbbs@gmail.com