Clinical trial · Interventional
Evaluation of Adherence to Rehabilitation: Autonomous and Guided, in the Observation and Treatment Response of Head and Neck Lymphedema in Neoplasms During Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
Head and neck lymphedema is a common complication after treatment for head and neck cancer. It can cause swelling of the face and neck, discomfort, reduced neck and jaw mobility, swallowing difficulties, and a negative impact on quality of life. One usual treatment approach includes manual lymphatic drainage, exercises, skin care, and the use of a compression garment worn for several hours each day. However, wearing a compression garment for a long period may be difficult for patients because of discomfort, appearance, social constraints, or practical limitations, which may reduce adherence to treatment. The ARAGORN study aims to determine whether a more autonomous rehabilitation program, based on patient education, self-drainage, targeted exercises, and short-duration compression bandaging performed twice daily, leads to better treatment adherence than the usual recommended approach using prolonged compression garment wear. The main question of the study is whether patients receiving the autonomous, guided rehabilitation program are more likely to adhere to their prescribed lymphedema treatment over the radiotherapy period than patients receiving the usual recommended care. The study hypothesis is that a patient-centered, self-management approach may improve adherence by making treatment easier to integrate into daily life, while maintaining potential benefits on swelling, symptoms, function, and quality of life.
Conditions
Conditions (2)
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autonomous Guided Rehabilitation Program | Other | — | UNRESOLVED |
| Usual recommended care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual recommended care
- description
- Participants assigned to this arm receive the usual recommended rehabilitation care for external head and neck lymphedema. This includes manual lymphatic drainage performed by a physiotherapist, daily cervico-facial and scapular exercises, skin care including skin monitoring and prevention of radiodermatitis, and use of an adapted compression garment for at least 8 hours per day, continuously or intermittently, with adherence monitoring.
- interventionNames
- Other: Usual recommended care
- type
- EXPERIMENTAL
- label
- Autonomous Guided Rehabilitation Program
- description
- Participants assigned to this arm receive an autonomous, guided rehabilitation program for external head and neck lymphedema. The program includes supervised education in self-manual lymphatic drainage, self-application of short-duration multilayer compression bandaging, targeted cervico-facial and mandibular exercises, daily cervico-facial and scapular exercises, and skin care. Self-bandaging is performed twice daily for approximately 1 hour per session and is associated with active exercises.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18 years or older * Histologically confirmed diagnosis of head and neck cancer * Postoperative status after surgical resection * Currently receiving adjuvant radiotherapy * No evidence of local tumor progression * Presence of head and neck lymphedema * Able to apply and remove the compression device independently or with the help of a caregiver * Clinically stable condition with no contraindication to lymphatic drainage or compression therapy * Affiliated with a social security system or beneficiary of such a system. Able to understand the study instructions * Able to follow the study procedures * Able to provide written informed consent Exclusion Criteria: * Confirmed or suspected active tumor * Confirmed or suspected local tumor recurrence * Medical contraindication to combined decongestive therapy * Acute dermatitis * Local infection * Open wound * Ongoing thrombosis * Documented primary lymphatic disease, such as congenital lymphedema * Cognitive impairment preventing understanding of the study protocol * Language barrier preventing understanding of the study protocol * Psychiatric condition preventing understanding of the study protocol * Person under legal protection guardianship or curatorship * Patient with a limitation-of-care decision.
References
Publications (0)
Data not yet available