Tongue CancerALT-MFNCT07682467
Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer
An observational study of Tongue Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Tongue cancer is a common malignant tumor in oral and maxillofacial surgery. After surgical resection, it is often accompanied by hemitongue defect. For obese patients (BMI≥30) with tongue cancer, the repair of hemitongue defect is due to thick subcutaneous fat and bloated traditional free flaps, which leads to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tongue Cancer
- What is being tested?
- The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hemitongue defect after surgery for obese (BMI≥30) tongue squamous cell carcinoma
Who may be able to join
- 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;
- Body mass Index: BMI≥30 kg/m² (meeting the diagnostic criteria for obesity);
- Age and physical condition: 18-75 years old;
- 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;
Who cannot join
- 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.
- Underlying diseases: Severe cardiovascular and cerebrovascular diseases, coagulation disorders, diabetes, and severe infectious diseases;
- Patients with mental disorders are unable to cooperate with follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer: A Pilot Study
Tongue cancer is a common malignant tumor in oral and maxillofacial surgery. After surgical resection, it is often accompanied by hemitongue defect. For obese patients (BMI≥30) with tongue cancer, the repair of hemitongue defect is due to thick subcutaneous fat and bloated traditional free flaps, which leads to swallowing and speech dysfunction. As a result, there is still a lack of good clinical repair plans at present, which seriously affects the quality of life of patients. There is an urgent need for safe and efficient targeted repair techniques.
This study intends to retrospectively collect 35 patients with hemitongue defects after surgery for obese (BMI≥30) tongue squamous cell carcinoma in a single center, to compare the repair effects of ALT-MF and traditional free flaps, and to evaluate the postoperative Wada drinking water test scores, speech acuity, etc. of the two groups of patients. This study explores solutions to problems such as bloat, slow functional recovery, and significant donor site damage caused by traditional repair techniques in obese patients, verifies the safety and efficacy of ALT-MF, clarifies the repair mechanism, provides a new strategy for hemitongue defect repair in obese tongue cancer patients, improves the quality of life of patients, and has important clinical value and social significance.
- Conditions
- Tongue Cancer
- Being tested
- The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer
- Medical subject headings
- Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancerProcedure or surgery
The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer
| Study group | Role | What they receive |
|---|---|---|
| ALT-MF | The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer Receives: Procedure: The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer | |
| ALT | The anterolateral thigh muscle flap (ALT) repairs hemitongue defects in patients with tongue cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wada Drinking Water experiment
The drinking process and response are observed. The assessment criteria are divided into 5 levels: able to drink all of the water at one time without choking, level 1 is normal; drinking all of the water in two attempts without choking, level 2 is suspicious; able to drink all of the water in one attempt but with choking, level 3 indicates mild swallowing disorder; drinking all of the water in more than two attempts with choking, level 4 indicates moderate disorder; and frequent choking and difficulty in drinking all of the water, level 5 indicates severe swallowing disorder.
Measured: 1week、1month、3months、6months、1year、2years after surgery
Secondary outcomes (3)
speech articulation
Speech intelligibility was assessed using a 7-point scale: 7 points for complete speech; 6 points for occasional speech errors; 5 points for intelligible speech with obvious errors; 4 points for speech that can be understood only by careful listening; 3 points for speech that can be understood only by repeated pronunciation; 2 points for speech that is generally unintelligible; and 1 point for speech that is unintelligible.
Measured: 1week、1month、3months、6months、1year、2years after surgery
Appearance satisfaction
To assess patient satisfaction with postoperative appearance, the 4th edition of the UW-QoL was used: 5 points for normal appearance; 4 points for minor changes in appearance; 3 points for changes that are bothersome but allow the patient to maintain a normal life; 2 points for changes that are bothersome and affect social activities; and 1 point for changes in appearance that make it difficult to interact with others.
Measured: 1week、1month、3months、6months、1year、2years after surgery
Tumor recurrence and metastasis
Tumor recurrence or metastasis should also be monitored. CT/MRI scans should be performed every 6 months for 2 years after surgery to monitor for tumor recurrence and metastasis. For patients with suspected recurrence or metastasis, further diagnostic tests, such as pathological biopsy and positron emission tomography-computed tomography (PET-CT), were conducted to confirm the diagnosis and guide subsequent treatment.
Measured: 3 months, 6 months, 1 year and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682467
- Sponsor's protocol ID
- SYSKY-2025-901-01
- Acronym
- ALT-MF
- Status last verified
- Oct 2025
- First submitted
- 25 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT07682467
- Acronym / sponsor ID
- ALT-MF / SYSKY-2025-901-01
- Conditions
- Tongue Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tongue cancer is a common malignant tumor in oral and maxillofacial surgery. After surgical resection, it is often accompanied by hemitongue defect. For obese patients (BMI≥30) with tongue cancer, the repair of hemitongue defect is due to thick subcutaneous fat and bloated traditional free flaps, which leads to swallowing and speech dysfunction. As a result, there is still a lack of good clinical repair plans at present, which seriously affects the quality of life of patients. There is an urgent need for safe and efficient targeted repair techniques.
This study intends to retrospectively collect 35 patients with hemitongue defects after surgery for obese (BMI≥30) tongue squamous cell carcinoma in a single center, to compare the repair effects of ALT-MF and traditional free flaps, and to evaluate the postoperative Wada drinking water test scores, speech acuity, etc. of the two groups of patients. This study explores solutions to problems such as bloat, slow functional recovery, and significant donor site damage caused by traditional repair techniques in obese patients, verifies the safety and efficacy of ALT-MF, clarifies the repair mechanism, provides a new strategy for hemitongue defect repair in obese tongue cancer patients, improves the quality of life of patients, and has important clinical value and social significance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALT-MF | – | Procedure: The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancerThe anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer |
| ALT | – | –The anterolateral thigh muscle flap (ALT) repairs hemitongue defects in patients with tongue cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hemitongue defect after surgery for obese (BMI≥30) tongue squamous cell carcinoma
Key inclusion criteria (4 listed)
- 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;
- Body mass Index: BMI≥30 kg/m² (meeting the diagnostic criteria for obesity);
- Age and physical condition: 18-75 years old;
- 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;
Key exclusion criteria (3 listed)
- 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.
- Underlying diseases: Severe cardiovascular and cerebrovascular diseases, coagulation disorders, diabetes, and severe infectious diseases;
- Patients with mental disorders are unable to cooperate with follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancerThe anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer | Procedure or surgery | ALT-MF |
Primary outcome
Wada Drinking Water experiment
Time frame: 1week、1month、3months、6months、1year、2years after surgery
The drinking process and response are observed. The assessment criteria are divided into 5 levels: able to drink all of the water at one time without choking, level 1 is normal; drinking all of the water in two attempts without choking, level 2 is suspicious; able to drink all of the water in one attempt but with choking, level 3 indicates mild swallowing disorder; drinking all of the water in more than two attempts with choking, level 4 indicates moderate disorder; and frequent choking and difficulty in drinking all of the water, level 5 indicates severe swallowing disorder.
3 secondary outcomes
speech articulation
Time frame: 1week、1month、3months、6months、1year、2years after surgery
Appearance satisfaction
Time frame: 1week、1month、3months、6months、1year、2years after surgery
Tumor recurrence and metastasis
Time frame: 3 months, 6 months, 1 year and 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tongue Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wada Drinking Water experiment (time frame: 1week、1month、3months、6months、1year、2years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.