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

Nutrition and swallowing assessment and short-term outcome evaluation of pre-treatment swallowing rehabilitative counselling in upper aerodigestive tract cancer patients undergoing surgery or radiotherapy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/059856
Enrollment
80
Registered
2023-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Control Intervention1: NIL: NIL

Sponsors

Postgraduate institute of Medical Education and Research Chandigarh
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactSourabha K Patro

PGIMER

sourabhlipi@gmail.com8872401912

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026