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A comparative study of dysphagia evaluation in post-operative oral cavity carcinoma received chemo-radiation treatment, one arm treated with standard volumetric modulated arc therapy, other arm treated with dysphagia optimized volumetric modulated arc therapy .

A prospective comparative evaluation of dysphagia in surgically resected oral cavity cancers treated by dysphagia optimized volumetric modulated arc therapy (Do-VMAT) versus standard volumetric modulated arc therapy (S-VMAT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044696
Enrollment
50
Registered
2022-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: C04- Malignant neoplasm of floor of mouth Health Condition 2: C03- Malignant neoplasm of gum Health Condition 3: C06- Malignant neoplasm of other and unspecified parts of mouth Health Condition 4: C02- Malignant neoplasm of other and unspecified parts of tongue

Interventions

Intervention1: Dysphagia optimized volumetric modulated arc therapy: In the intervention arm dysphagia related structures are contour as organ at risk and dosimetric constrain given to spare the struc

Sponsors

Homi Bhabha Cancer Hospital And Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven squamous cell carcinoma of oral cavity (excluding lip) Written informed consent Age - 18 to 70 years Both sexes Karnofsky performance status 70 or above Adequate surgical resection of primary and nodal diseas Non-metastatic disease Patients planned for adjuvant chemo-radiation only (Extra capsular extension +ve, Margin +ve or patients receiving NACT prior to surgery) Only patients taking intake orally at the time of start of radiation will be included

Exclusion criteria

Exclusion criteria: 1.Any histopathology other than SCC 2.Previous radiotherapy to the head and neck region 3.Synchronous or metachronous malignancy 4.Pregnant or lactating women 5.Uncontrolled concurrent illness like Diabetes mellitus (DM), Hypertension (HTN), tuberculosis 6.Evidence of distant metastasis 7.Recurrent or residual disease. 8.Current or previous tracheostomy placement. 9.Posterior pharyngeal wall, post cricoid and retro pharyngeal lymph node involvement 10.Patients on Ryles tube feeding at the time of RT start will be excluded.

Design outcomes

Primary

MeasureTime frame
To compare acute dysphagia in postoperative oral cavity squamous cell carcinoma patients treated with DO-VMAT versus standard VMAT as per RTOG acute toxicity guidelineTimepoint: To compare acute dysphagia in postoperative oral cavity squamous cell carcinoma patients treated with DO-VMAT versus standard VMAT as per RTOG acute toxicity guideline Data that will be collected weekly during treatment, after 4 weeks, then monthly up to 3 months from treatment completion—

Secondary

MeasureTime frame
To compare disease free survival (DFS) and objective assessment for dysphagia using MD Anderson Dysphagia Inventory (MDADI) scoring, 100 ml water swallowing test and Video fluoroscopy (VF) in patients treated with DO-VMAT versus standard VMAT.Timepoint: done at baseline, 3months, 6 months, and 12 months from completion of treatment.—

Countries

India

Contacts

Public ContactDr Pritam Mondal

Mahamana Pandit Madan Mohan Malaviya Cancer Centre And Homi Bhabha Cancer Hospital

mondalpritam555@gmail.com9735852892

Outcome results

None listed

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