LymphedemaARAGORNNCT07838857
Evaluation of Adherence to Rehabilitation: Autonomous and Guided, in the Observation and Treatment Response of Head and Neck Lymphedema in Neoplasms During Radiotherapy
A study testing Autonomous Guided Rehabilitation Program and Usual recommended care in people with Lymphedema and Head and Neck Neoplasms, run by Hopital Forcilles.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Head and Neck Neoplasms
- What is being tested?
- Autonomous Guided Rehabilitation Program and Usual recommended care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Confirmed or suspected active tumor
- Confirmed or suspected local tumor recurrence
- Medical contraindication to combined decongestive therapy
- Acute dermatitis
- Local infection
- Open wound
Show all 13Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Lymphedema, Head and Neck Neoplasms
- Being tested
- Autonomous Guided Rehabilitation Program, Usual recommended care
- Keywords
- Lymphedema, Head and Neck Neoplasms
- Medical subject headings
- Lymphedema, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomous Guided Rehabilitation ProgramOther
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.
Usual recommended careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Autonomous Guided Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and end of radiotherapy, approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start22 Sep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Forcilles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Diaz, PhD (c), Study director, Hôpital Forcilles Fondation Cognacq-JayStéphane Henriot, Principal investigator, Hôpital Forcilles Fondation Cognacq-Jay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838857
- Sponsor's protocol ID
- 2026-A00158-43
- Acronym
- ARAGORN
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence to Rehabilitation: Autonomous and Guided, in the Observation and Treatment Response of Head and Neck Lymphedema in Neoplasms During Radiotherapy
- ClinicalTrials.gov ID
- NCT07838857
- Acronym / sponsor ID
- ARAGORN / 2026-A00158-43
- Conditions
- Lymphedema, Head and Neck Neoplasms
- Keywords
- Lymphedema, Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hopital ForcillesUniversity, hospital or other
- Study start
- 22 Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual recommended care | Active comparator | Other: Usual recommended careParticipants 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. |
| Autonomous Guided Rehabilitation Program | Experimental | Other: Autonomous Guided Rehabilitation ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- Confirmed or suspected active tumor
- Confirmed or suspected local tumor recurrence
- Medical contraindication to combined decongestive therapy
- Acute dermatitis
- Local infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomous Guided Rehabilitation ProgramParticipants 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 |
| Usual recommended careParticipants 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 |
Primary outcome
Proportion of Participants With Treatment Adherence Rate ≥80% During the Radiotherapy Period
Time frame: From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks
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.
9 secondary outcomes
Number of participants with adverse events related to lymphedema management as assessed by the common terminology criteria for adverse events
Time frame: From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks
Global Rating of Change Score During the Radiotherapy Period
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
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
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in pain visual analog scale score at the end of rariotherapy
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
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in eating assessment tool-10 score at the end of radiotherapy
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in maximum mouth opening at the end of radiotherapy
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Change from baseline in EORTC QLQ-H&N35 score at the end of radiotherapy
Time frame: Baseline and end of radiotherapy, approximately 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Diaz, PhD (c) study director
Hôpital Forcilles Fondation Cognacq-Jay
Stéphane Henriot principal investigator
Hôpital Forcilles Fondation Cognacq-Jay
Questions about this trial
What is this clinical trial studying?
A study testing Autonomous Guided Rehabilitation Program and Usual recommended care in people with Lymphedema and Head and Neck Neoplasms, run by Hopital Forcilles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Diaz - Head of rehabilitation service, PhD (c) (+33160646130, cdiaz.physio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Treatment Adherence Rate ≥80% During the Radiotherapy Period (time frame: From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.