Clinical trial · Interventional
A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment
The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Neck morbidity after radiation therapy and surgery includes difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. In addition, the researchers will find out whether the study procedure is effective at reducing neck morbidity and improving quality of life after cancer treatment. The researchers will measure quality of life by having participants answer questionnaires.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRQOL instruments | Other | — | UNRESOLVED |
| LENT SOMA instrument | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Quality of life questionnaires
- description
- After the Fat Flap Reconstruction at 6 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment with either the Head and Neck Surgery (HNS) or Plastic \& Reconstructing Surgery (PLA) care team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team. At 12 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment. Patients will be asked to complete inter-incisor distance measurement and barium swallow assessment, done by a member of the SLP team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team.
- interventionNames
- Other: HRQOL instruments
- Other: LENT SOMA instrument
Primary outcomes (1)
- measure
- Proportion of patients that experience a complications
- timeFrame
- within 90 days post operatively
- description
- Flap-related surgical complications - subjective and objective outcomes using validated instruments and CTCAE V5.0 i. Partial/total flap loss ii. Venous/arterial thrombosis iii. Infection iv. Hematoma v. Seroma Donor site i. Hematoma ii. Infection iii. Seroma iv. Dehiscence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years or older * Diagnosed with HNSCC (e.g., oropharyngeal, hypo/laryngeal SCC) * Primary treatment is with radiotherapy with or without chemotherapy * Salvage neck dissection is subsequently indicated for persistent or recurrent, nonmucosal disease in cervical lymph nodes * At the time of salvage neck dissection additional flap coverage is indicated to improve carotid coverage or replace missing skin Exclusion Criteria: * Patients with primary site mucosal recurrence in addition to neck disease
References
Publications (0)
Data not yet available