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Evaluating oral reactions to radiotherapy in Head and Neck Cancer Patients undergoing chemotherapy and radiotherapy

Evaluation of Severe Oral Mucositis in Locally Advanced Unresectable Head and Neck Squamous Cell Carcinoma (HNSCC) Patients Treated by Chemoradiotherapy (CTRT) Using Volumetric Modulated Arc Therapy (VMAT) with Simultaneous Integrated Boost (SIB) A Single Institution Prospective Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097102
Enrollment
500
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C05- Malignant neoplasm of palate Health Condition 3: C09- Malignant neoplasm of tonsil Health Condition 4: C10- Malignant neoplasm of oropharynx Health Condition 5: C12- Malignant neoplasm of pyriform sinus Health Condition 6: C13- Malignant neoplasm of hypopharynx Health Condition 7: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven HNSCC (Except Oral cavity) 2. Age - 18 to 70 years 3. Both sexes 4. ECOG Score 2 or less 5. Non-metastatic disease (T1-T4a, N0-3b). 6. Patients planned for radical treatment with chemo-radiation with dose of RT 66Gy in 30 fractions 7. Patient being treated using VMAT-SIB technique with concurrent cisplatin. 8. Willingness to sign informed consent form.

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. Evidence of distant metastasis (any T, any N, M1). 6. Recurrent or residual disease 7. Oral cavity SCC patients 8. Previously operated patient in HN region. 9. Any other concurrent chemotherapy other than cisplatin

Design outcomes

Primary

MeasureTime frame
To evaluate severe oral mucositis RTOG grade less than and equal to grade 3 in unresectable HNSCC treated with VMAT SIB along with concurrent cisplatin using RTOG Acute Morbidity Criteria Objective criteria and Mouth and Throat soreness score MTS and QLQ C30 HN questionnaires subjective patient reported criteria and their correlation.Timepoint: Patients will be assessed at least once weekly during radiation. The first post treatment visit will be 1 weeks after completion of radiotherapy. Subsequent visits will be 1 month and 3 month post RT.—

Secondary

MeasureTime frame
To evaluate other acute toxicities like skin reaction, dysphagia, odynophagia. • To assess the need of – Feeding tube placement – Hospitalization – Opioid use – Significant weight loss (> 5 kg) • To assess the correlation between various host and tumour related factors with treatment response and outcome.Timepoint: Patients will be assessed at least once weekly during radiation. The first post treatment visit will be 1 weeks after completion of radiotherapy. Subsequent visits will be 1 month and 3 month post RT.—

Countries

India

Contacts

Public ContactGaurav Arya

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

satyajeetdas98@gmail.com9689604241

Outcome results

None listed

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