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New light treatment could fight oral cancer without surgery

NCT ID NCT06876038

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a low-cost approach to treat pre-cancerous and cancerous mouth lesions using a drug (5-ALA) that makes abnormal cells sensitive to light, followed by laser light delivered through a handheld device. The goal is to destroy these lesions without surgery. The trial will enroll 65 adults with high-risk oral lesions and follow them for one year to see if the treatment works and if the device is easy to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5-Aminolevulinic acid (5-ALA)
What this could lead to
If successful, this could provide an affordable, non-surgical treatment for early oral cancers and pre-cancers, especially in areas with limited resources.
What could go wrong
This is a small, early-phase trial (65 people) testing a new device and drug combination. It may not work for all lesion types, and long-term recurrence or side effects are unknown.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 65 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Subject Inclusion Criteria 1. One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter. 2. Willing and available for follow-up for at least one year and at prerequisite time intervals. 3. All patients above the age of 18 years and willing to voluntarily give a signed informed consent. 4. Karnofsky Performance Score above 80 or ECOG 0 or 1. 5. The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual * Hemoglobin level above or equal to 10% * WBC \>3000/mm3 * Platelets count \>100000/mm3 * Total bilirubin, AST (SGOT), ALT (SGPT) \< 1.5 times the Upper Limit Normal * eGFR \> 60 ml/min * Serum Creatine less than 2 times the Upper Limit of laboratory normal * INR/ PT and PTT within laboratory normal limits Exclusion criteria: 1. Hypersensitivity against active substances and porphyrins. 2. Known diagnosis of porphyria. 3. Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts). 4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness. 5. Subjects with inherited or acquired bleeding and clotting disorders 6. Women who are breastfeeding/ have a positive urine pregnancy test or are planning their family. 7. Patients who have taken supplements of retinol, beta carotene, vitamin E, Selenium, or other chemo-preventive therapy at least one month prior to the baseline visit. 8. Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease. 9. Patients with behavioral and cognitive impairment. 10. Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers. 11. Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision. 12. The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence. 13. Patient who was in a clinical trial for 4 weeks before participation in the present trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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

  • Jawaharlal Nehru Medical College, AMU

    Aligarh, Uttar Pradesh, 202002, India

  • Karkinos Healthcare Hospitals

    Ernākulam, Kerala, India

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