Sparing swallowing and aspiration risk organs in head and neck cancer treatment
The SWOAR Trial: A Phase III Trial Evaluating Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas
This study is testing a new type of radiation therapy that aims to protect swallowing and aspiration-related organs in people with head and neck cancer to see if it helps them swallow better and have fewer side effects.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Jhajjar, Haryana) |
| Trial ID | NCT05187091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx requiring bilateral neck radiotherapy.
Not a fit: Patients with early-stage glottic carcinoma, metastatic disease, or those who have previously received head and neck radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve swallowing function and quality of life for patients undergoing treatment for head and neck cancer.
How similar studies have performed: Other studies have shown promising results with similar swallowing-sparing techniques in radiation therapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jhajjar, Haryana
- Nci, Aiims — Jhajjar, Haryana, India (Recruiting)
Study contacts
- Study coordinator: Aman Sharma, MD
- Email: amans757@gmail.com
- Phone: +917018529339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.