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Assessment of speech & swallowing outcome

A prospective observational study to compare speech and swallowing outcomes in patients undergoing treatment for oral tongue cancers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/01/023080
Enrollment
120
Registered
2020-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

TATA MEMORIAL HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients with cancers of oral tongue (Stage I-stage IVa) -Treatment naïve -Age 18-75 years -Literate patients -ECOG 0,1,2 performance status

Exclusion criteria

Exclusion criteria: -Recurrent or second primary cases. -Post neo- adjuvant chemotherapy. -Patients requiring mandibular resection as a part of the surgery. -Other associated malignancies. -Any diagnosed neuromuscular condition known to affect speech and swallowing function. -Patients with preoperative tracheostomy. -Non-squamous histology

Design outcomes

Primary

MeasureTime frame
-To assess the speech and swallowing outcomes in patients undergoing treatment for oral tongue squamous cell carcinoma (OTSCC). -Evaluation will be done comparing the SHI- score & EAT-10 score at specified time points.Timepoint: Speech and swallowing outcomes’ assessment to be done at preoperatively (within 1 month of surgery) and at 4-6 weeks (before start of adjuvant treatment, when indicated), at 6 months and12 months following surgery.—

Secondary

MeasureTime frame
-The performance of speech and swallowing will be compared between the clusters. -Differences between the groups will be assessed using X2, Fisher’s exact, Wilcoxon Mann-Whitney and Kruskall-Wallis tests. -The baseline status like T-Stage, Type of reconstruction done will be considered for the coxproportional hazards regression analysis. -An extended cox-model will account also for possible time-varying confounding factors (Eg: type of treatment)Timepoint: -Speech and swallowing outcomes’ assessment to be done at preoperatively (within 1 month of surgery) and at 4-6 weeks (before start of adjuvant treatment, when indicated), at 6 months and 12 months following surgery.—

Countries

India

Contacts

Public ContactDr SHIVAKUMAR THIAGARAJAN

TATA MEMORIAL HOSPITAL

drshiva78in@gmail.com9846572399

Outcome results

None listed

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