Evaluation of Adherence to Rehabilitation: Autonomous and Guided, in the Observation and Treatment Response of Head and Neck Lymphedema in Neoplasms During Radiotherapy

NCT07838857 | Not Yet Recruiting

• 1 other identifier: 2026-A00158-43
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lymphedema; Head and Neck Neoplasms

Keywords

Lymphedema; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks

Secondary Outcomes (9)

• Number of participants with adverse events related to lymphedema management as assessed by the common terminology criteria for adverse events

  From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks

• Global Rating of Change Score During the Radiotherapy Period

  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

  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

  Baseline and end of radiotherapy, approximately 7 weeks

• Change from baseline in pain visual analog scale score at the end of rariotherapy

  Baseline and end of radiotherapy, approximately 7 weeks

Study Arms (2)

Usual recommended care

ACTIVE COMPARATOR

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

Autonomous Guided Rehabilitation Program

EXPERIMENTAL

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

Interventions

Autonomous Guided Rehabilitation Program OTHER

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.

Autonomous Guided Rehabilitation Program

Usual recommended care OTHER

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.

Usual recommended care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Forcilles: lead

MeSH Terms

Conditions

Lymphedema; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Carlos Diaz, PhD (c)

  Hôpital Forcilles Fondation Cognacq-Jay

  STUDY DIRECTOR

• Stéphane Henriot

  Hôpital Forcilles Fondation Cognacq-Jay

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Diaz - Head of rehabilitation service, PhD (c)

CONTACT

+33160646130; cdiaz.physio@gmail.com

Andreia Gomes Lopes

CONTACT

+33160646293; alopes@cognacq-jay.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the outcomes assessor is masked to treatment allocation. Weekly adherence assessment is performed by a physiotherapist who is distinct from the therapist delivering the intervention and patient education. The masked assessor does not have access to the randomization list or to the content of treatment sessions. Patient self-monitoring materials and photographs used for assessment are prepared to avoid revealing the assigned intervention whenever possible. Participants are instructed not to disclose their assigned treatment to the assessor. Any accidental unmasking is documented in the case report form.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to one of two parallel groups: usual recommended care or autonomous guided rehabilitation. Each participant follows the assigned intervention during the radiotherapy period, approximately 7 weeks. No crossover or planned change of treatment modality is included in the study design.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: September 22, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-06