Health Condition 1: C131- Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect Health Condition 2: C329- Malignant neoplasm of larynx, unspecified Health Condition 3: C109- Malignant neoplasm of oropharynx,unspecified Health Condition 4: C029- Malignant neoplasm of tongue, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Endocrine and salivary gland malignancies of the head and neck not involving the upper aerodigestive tract. 2. Second primary malignancies. 3. Recurrent disease/Relapse 4. Uncontrolled co-morbidities limiting the primary management of the disease. 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pre and post-treatment nutritional status in patients of upper aerodigestive tract cancers to understand the impact of treatment on nutrition. 2. Status of swallowing and associated patient-related outcome measures both pre and post-treatment in patients of upper aerodigestive tract cancers. 3. Speech intelligibility in patients of oral cavity cancers. Timepoint: 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
| Measure | Time frame |
|---|---|
| • Diagnostic and therapeutic delays for patients of upper aerodigestive tract cancers • Outcomes from post-hoc subgroup analysis of the patients including o swallowing impairment and its possible contributing factors in correlation with pretreatment clinical, radiological and nutritional assessment findings o Swallowing functionality and nutritional status of patients in correlation with the oncological clearance for extensive tumors (Post and superior extensions) in the surgically treated patients. o Swallowing functionality and nutritional status of patients undergoing trans-oral robotic surgery for cancers of oropharynx and neck secondaries with unknown primary compared to cases treated by conventional surgery. Timepoint: o There is no defined endpoint for the study, and all patients completing the follow-up protocol will be continuously followed up every 3 months till the end of the study period of the thesis. | — |
Countries
India
Contacts
PGIMER