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Effect of post operative oral exercises on swallowing function in head and neck cancer patients

Effect of Post-Operative Structured Oral Exercise therapy on swallowing function in oral cavity cancer patients: a Randomized Controlled Trial(POSE-SWALLOW) - POSE-SWALLOW

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077995
Enrollment
80
Registered
2024-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: C021- Malignant neoplasm of border of tongue Health Condition 2: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: POSE Group(Structured oral exercises + standard care): Self-administered swallowing exercises will be prescribed based on individual assessments and will have to be performed with up t

Sponsors

Dr Kirti Pundir
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All histopathologically proven operable SCC of oral cavity with stage (cT1-4b N1-3 M0) undergoing resection of primary tumor +/-reconstructive procedures with curative intent. 2. Patients who can tolerate atleast a thin liquid diet by postoperative day 10 of surgery. 3. ECOG PS 1-2

Exclusion criteria

Exclusion criteria: 1. Recurrent oral cavity cancers. 2. Previous history of pharyngeal or esophageal malignancy. 3. Existing difficulty in swallowing due to causes other than current malignancy eg.hemiparesis, neuromuscular disorder etc. 4. Not giving informed consent.

Design outcomes

Primary

MeasureTime frame
To study the effect of post-operative Structured Oral Exercise Therapy (POSE) on swallowing function as assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in oral cavity cancer patients compared to those who receive standard care (SC) at 4-6 weeks and 4-6 months post-surgeryTimepoint: 4-6 weeks and 4-6 months post-surgery—

Secondary

MeasureTime frame
1. To study the effect of POSE on other swallowing outcomes like Eating Assessment tool (EAT-10), tube dependency, mouth opening, gargle, whistle, pain at 4-6 weeks and 4-6 months post-surgery. 2. To assess the relationship between patient-reported symptoms of oropharyngeal dysphagia (OD) using EAT-10 and objective assessment of swallowing function like aspiration-penetration score and pharyngeal residue score using FEES. 3. To study the effect of POSE on speech as assessed by Continuous speech assessment in terms of speech intelligibility and didokokinesis. 4. To study the impact of POSE on health-related Quality of Life (HR-QOL) as measured by FACT-G and FACT-HN measured at 4-6 weeks and 4-6 month post-operatively. Timepoint: 4-6 weeks and 4-6 months post-operatively.—

Countries

India

Contacts

Public ContactDr Nivedita Sharma

AIIMS Jodhpur

nivsha1985@gmail.com7034635141

Outcome results

None listed

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