Assessing the function of swallowing structures in delivering higher dose per fractions RT in locally advanced head and neck cancer.

A study to assess the Radiation dose to Dysphagia/Aspiration at Risk Structures(DARS) and its impact on quality of life in patients receiving hypo-fractionated RT in locally advanced Head and Neck Squamous cell Carcinoma (LA-HNSCC) - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067205

Enrollment

Registered

2024-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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: C050- Malignant neoplasm of hard palate Health Condition 3: C139- Malignant neoplasm of hypopharynx,unspecified Health Condition 4: C329- Malignant neoplasm of larynx, unspecified Health Condition 5: C109- Malignant neoplasm of oropharynx,unspecified

Interventions

Intervention1: Radiation therapy: Patient will be treated with 55 Gy in 20 fractions (#) over 4 weeks with 2.75 Gy/fraction, mean dose to DARS which will be not be overlapping with CTV would be limite

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants above 18 years of age diagnosed with head and neck cancer. 2.ECOG(Eastern Cooperative Oncology Group)status 0 or 1 will be taken. 3.Adult patients admitted with locally advanced biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx (stage II–IVA).

Exclusion criteria

Exclusion criteria: 1.Patients with tumors involving the thyroid, nasal cavity, nasopharynx and paranasal sinus are not eligible as confirmed by CECT /MRI / PET- CT findings and biopsy findings. 2.Patients with distant metastasis. 3.Patients who have received radiotherapy previously 4.Relapse/recurrence 5.Pregnant women. 6.Tracheostomized patient. 7.Body weight less than 30 kgs.

Design outcomes

Primary

Measure	Time frame
Sparing of dysphagia aspiration associated risk structure,improved swallowing during and post treatment.Timepoint: assessment shall be done on day of admission,3months,6months,1yr post completion of RT.	—

Secondary

Measure	Time frame
Hypofractionated schedule for treatment of head and neck cancer.Timepoint: 18 months	—

Countries

India

Contacts

Public ContactDr Dinesh Makuny

Yenepoya medical college

dineshm@yenepoya.edu.in8891717361

Outcome results

None listed

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