An interventional study of Autonomous Guided Rehabilitation Program and Usual recommended care in Lymphedema and Head and Neck Neoplasms, sponsored by Hopital Forcilles. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Hopital Forcilles · Not applicable, Interventional, and Supportive care
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.
ARAGORN is a prospective, single-center, randomized controlled trial evaluating two rehabilitation strategies for external head and neck lymphedema in patients treated with adjuvant radiotherapy for head and neck cancer. Participants are randomized in a 1:1 ratio to either the usual recommended rehabilitation approach or an autonomous, guided self-management rehabilitation program.
The rationale for the study is that external head and neck lymphedema is frequent after head and neck cancer treatment and may be associated with pain, cosmetic and functional discomfort, reduced cervical or mandibular mobility, swallowing difficulties, and impaired quality of life. Although combined decongestive therapy is commonly recommended, adherence to prolonged compression garment wear is often limited in clinical practice. A shorter, structured, patient-performed bandaging approach combined with self-drainage and exercises may represent a more acceptable strategy for patients.
Participants allocated to the usual recommended care group receive combined decongestive therapy, including manual lymphatic drainage performed by a physiotherapist, daily cervico-facial and scapular exercises, skin care, and use of an adapted compression garment for at least 8 hours per day.
Participants allocated to the autonomous guided rehabilitation group receive education and supervised training in self-lymphatic drainage, short-duration multilayer self-bandaging, targeted cervico-facial and mandibular exercises, daily cervico-facial and scapular exercises, and skin care. The self-bandaging program is performed twice daily, with each session lasting approximately 1 hour, in association with active exercises. The intervention is designed to support patient autonomy while maintaining safety through initial education and regular follow-up.
The planned sample size is 56 participants, with 28 participants in each group. Each participant is followed during the radiotherapy treatment period, approximately 7 weeks. The total planned duration of the study is approximately 26 months, including recruitment and follow-up.
Adherence is assessed throughout follow-up using patient-reported treatment use, checked during weekly visits. Weekly adherence assessment is performed by a physiotherapist who is distinct from the therapist providing the intervention and who is kept blinded to treatment allocation whenever possible. Measures are taken to maintain blinding, including separating intervention delivery from assessment and instructing participants not to disclose their treatment group to the evaluator.
The main analysis will compare the proportion of adherent participants between the two randomized groups, using the predefined adherence threshold specified in the outcome measure module. Secondary and exploratory analyses will evaluate clinical feasibility, patient-perceived change, safety and tolerance, and changes in lymphedema-related clinical and functional parameters over the study period. Analyses will follow the intention-to-treat principle and will be reported according to CONSORT recommendations.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 56 is above the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Hopital Forcilles is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Usual recommended care
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.
Other: Autonomous Guided Rehabilitation Program
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.
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.
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.
Time frame: From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks
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.
Time frame: From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks
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.
Time frame: Weekly from the first follow-up visit to the end of radiotherapy, approximately 7 weeks
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.
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
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.
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in pain visual analog scale score at the end of rariotherapy
Pain intensity is assessed using a visual analog scale (0 to 10 scale). A score of 0 indicates no pain, and the highest score indicates the worst possible pain. A decrease in score indicates improvement in pain intensity.
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in cervical range of motion measured by CROM at the end of radiotherapy
Cervical mobility is assessed using the Cervical Range of Motion device. Cervical movements are measured in degrees, with higher values indicating greater cervical range of motion. The outcome assesses change in cervical mobility from baseline to the end of radiotherapy.
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in eating assessment tool-10 score at the end of radiotherapy
Swallowing-related symptoms are assessed using the Eating Assessment Tool-10. The EAT-10 is a 10-item patient-reported questionnaire with a total score ranging from 0 to 40. Higher scores indicate worse swallowing-related symptoms. A score ≥3 is considered abnormal.
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in maximum mouth opening at the end of radiotherapy
Maximum mouth opening is measured as the maximal inter-incisal distance using the TheraBite Range of Motion scale. The measurement is performed in three successive trials, and the mean of the three values is used for analysis. Higher values indicate greater mouth opening.
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in EORTC QLQ-H&N35 score at the end of radiotherapy
Head and neck cancer-specific quality of life is assessed using the EORTC QLQ-H\&N35 questionnaire. Scores are transformed to a 0 to 100 scale according to EORTC scoring procedures. For symptom scales and single items, higher scores indicate greater symptom burden or more problems.
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.
Of 175 non-industry interventional studies with no phase under Lymphedema, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 68. This study's planned 25 months is close to that.
Counting every sponsor, half of 197 studies reached it within 25 months; a quarter within 9 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hopital Forcilles