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New radiation method aims to save swallowing in cancer patients

NCT ID NCT05187091

Symptom relief Sponsor: All India Institute of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests a new way to give radiation to people with head and neck cancer. The goal is to see if protecting the parts of the throat used for swallowing can help patients eat and drink better after treatment. About 136 adults with certain types of head and neck cancer will be randomly assigned to receive either the standard radiation or the new swallowing-sparing technique. The main focus is on how well patients can swallow 6 months after treatment, as reported by the patients themselves.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders head and neck neoplasm Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck neoplasms Swallowing sparing imrt

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nci, Aiims

    RECRUITING

    Jhajjar, Haryana, 124105, India

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