New surgical flap aims to restore swallowing and speech in obese tongue cancer patients

NCT ID NCT07682467

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Recruitment status, easiest to join first

Recruiting now
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 This study
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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Status unknown
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First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This pilot study tests a new surgical technique called the anterolateral thigh myofascial fat composite flap (ALT-MF) for repairing tongue defects after cancer surgery in obese patients (BMI 30 or higher). Traditional flaps can be too bulky in obese patients, leading to problems with swallowing and speech. The study compares ALT-MF with traditional flaps in 35 patients to see if it improves swallowing function and speech clarity after surgery.

What this could mean

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

Active substance
Anterolateral thigh myofascial fat composite flap (ALT-MF) surgical procedure
What this could lead to
If successful, this technique could offer a better surgical option for obese patients with tongue cancer, improving their ability to swallow and speak after surgery.
What could go wrong
This is a small pilot study with only 35 participants, so results may not apply to all patients. The new flap may not outperform traditional methods and carries standard surgical risks.

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Study facts

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

Participants

35 people

The number who actually took part.

Started

May 2023

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.

Who is studied

Patients with hemitongue defect after surgery for obese (BMI≥30) tongue squamous cell carcinoma

Ages

18 to 75 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.

Inclusion Criteria: 1. Disease and surgical indications: Pathologically confirmed as tongue squamous cell carcinoma, having received surgical treatment (hemitongue resection + free flap repair), tumor stage is T1-T2 (according to AJCC 7th Edition), N0-N1 stage, M0 stage; 2. Body mass Index: BMI≥30 kg/m² (meeting the diagnostic criteria for obesity); 3. Age and physical condition: 18-75 years old; 4. Cooperation: Follow the doctor's advice for follow-up after the operation and be able to cooperate with the assessment of swallowing and speech functions; Exclusion Criteria: 1. Disease-related: If the tumor invades the base of the tongue or extends beyond half of the tongue, an extended resection is performed; Combined with extensive cervical lymph node metastasis (N2 or above) or distant metastasis (M1 stage); There is a previous history of radiotherapy or surgery for head and neck tumors. 2. Underlying diseases: Severe cardiovascular and cerebrovascular diseases, coagulation disorders, diabetes, and severe infectious diseases; 3. Patients with mental disorders are unable to cooperate with follow-up visits

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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.

Contacts and locations

Locations

  • Sun Yat-Sen Memorial Hospital

    Guangzhou, China

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