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.
Adults aged 18 years or older
Histologically confirmed diagnosis of head and neck cancer
Postoperative status after surgical resection
Currently receiving adjuvant radiotherapy
Confirmed or suspected active tumor
Confirmed or suspected local tumor recurrence
Medical contraindication to combined decongestive therapy
Acute dermatitis
Parallel
Autonomous Guided Rehabilitation Program
Other interventionParticipants 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.
Usual recommended care
Other interventionParticipants 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.
Proportion of Participants With Treatment Adherence Rate ≥80% During the Radiotherapy Period
Treatment adherence is defined for each participant as the percentage of days on which the prescribed lymphedema management modality is performed according to the protocol, divided by the total number of expected treatment days. Participants are classified as adherent if their individual adherence rate is ≥80% over the full treatment period and non-adherent if their adherence rate is \<80%. Adherence is collected using a daily self-monitoring diary and checked during weekly follow-up visits.
Number of participants with adverse events related to lymphedema management as assessed by the common terminology criteria for adverse events
Adverse events are collected prospectively throughout follow-up. For each event, the clinical nature, severity according to the Common Terminology Criteria for Adverse Events (CTCAE), date of onset, and relationship to the assigned compression modality are recorded. The outcome will be reported as the number of participants experiencing at least one adverse event.
Global Rating of Change Score During the Radiotherapy Period
The Global Rating of Change is a patient-reported ordinal scale used to assess perceived clinical change since the previous assessment. Scores range from -7, indicating very important worsening, to +7, indicating very important improvement. A score of 0 indicates no change.
Change from baseline in external head and neck lymphedema measurements at the end of radiotherapy
External head and neck lymphedema is assessed using standardized tape measurements, including upper neck circumference, lower neck circumference, and ear-to-ear distance through a submental landmark. Measurements are performed twice in a standardized sitting position, and the mean value is used for analysis. Change is expressed as the percentage change from baseline; a decrease indicates improvement in lymphedema.
Change from baseline in clinical stage of external Head and Neck Lymphedema according to the Földi Scale at the end of radiotherapy
The clinical severity of external head and neck lymphedema is assessed using the Földi scale, which classifies lymphedema severity according to tissue consistency and reversibility of swelling. The scale ranges from stage 0 to stage III, with higher stages indicating more severe lymphedema.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
