Sparing swallowing and aspiration risk organs in head and neck cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SWOAR Trial aims to evaluate the effectiveness of intensity-modulated radiotherapy (IMRT) that spares structures related to swallowing and aspiration in patients with head and neck squamous cell carcinoma (HNSCC). Participants will be randomized to receive either the SWOAR IMRT or standard IMRT while undergoing radical concurrent chemoradiotherapy or radiotherapy. The primary outcome will be assessed using the MD Anderson Dysphagia Inventory (MDADI) at 6 months post-treatment, with secondary objectives focusing on aspiration prevention and toxicity assessments over time. This trial seeks to improve swallowing function and reduce complications associated with radiation therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 or above and less than 70 years
2. Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx.
3. Stage T1-4, N0-3, M0 disease with histologically confirmed squamous cell carcinoma requiring bilateral neck radiotherapy and where sparing of contra lateral or one submandibular gland is possible
4. Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment
5. Karnofsky performance score greater or equal 70
6. Available to attend long term follow- up;
7. Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
8. Willingness to undergo FEES.
9. Written informed consent for treatment.
10. Available to attend long term follow- up

Exclusion Criteria:

1. Early Carcinoma Glottis (T1-T2, N0M0)
2. Metastatic disease.
3. Previous radiotherapy to the head and neck region
4. Lateralised tumours, requiring unilateral irradiation
5. Patients requiring radiation to both submandibular glands
6. Evidence of pre-existing swallowing dysfunction (not related to HNC);
7. Major head and neck surgery (excluding biopsies/tonsillectomy);
8. Tracheostomy placement
9. Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy, trial assessments or follow-up
10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).

Where it's running

• Nci, Aiims
  Jhajjar, Haryana, India Recruiting

Study contacts

• Study coordinator: Aman Sharma, MD
• Email: amans757@gmail.com
• Phone: +917018529339

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.