None listed
Conditions
Brief summary
This study will investigate the treatment of head and neck lymphoedema in a head and neck cancer population. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a previous diagnosis of oral, nasopharyngeal, oropharyngeal, laryngeal, or hypopharyngeal cancer treated with chemoradiation, postoperative radiation or definitive radiation with curative intent. Study details All participants will undergo measurements and lymphatic imaging of the head and neck using near infra-red fluorescence lymphatic imaging, in order to examine swelling. Participants will be randomly allocated (by chance) to receive either compression therapy or manual lymphatic drainage over a period of 6 weeks. Compression therapy involves wearing a compression neck/face support and a flat foam insert for up to 8 hours per 24 hours. Manual lymphatic drainage will be administered by a therapist twice a week and participants will also be trained to self-administer this therapy at home. Participants in both treatment groups will be evaluated after 6 weeks and 12 weeks of therapy in order to evaluate effect on lymphoedema. It is hoped that this study will help us to determine the most effective therapy modality to treat head and neck lymphoedema and will provide valuable information to inform future studies of this type.
Interventions
This study employs a randomised controlled trial comparing two therapy modalities for head and neck lymphoedema management. All participants will undergo the same battery of assessments including imaging of their head and neck lymphatics with near infra-red fluorescence lymphatic imaging. Participants will be randomised to an intervention group.
Those randomised to group A will receive treatment with compression therapy, a common component of standard care for head and neck lymphoedema treatme
This study employs a randomised controlled trial comparing two therapy modalities for head and neck lymphoedema management. All participants will undergo the same battery of assessments including imaging of their head and neck lymphatics with near infra-red fluorescence lymphatic imaging. Participants will be randomised to an intervention group. Those randomised to group A will receive treatment with compression therapy, a common component of standard care for head and neck lymphoedema treatment. They will be fitted with a compression neck/face support and a flat foam insert by an occupational therapist or physiotherapist. They will be provided with written and verbal instructions and will be requested to apply the compression themselves as tolerated gradually increasing to 8 hours in every 24 hours. The duration of the intervention is 6 weeks. Those randomised to group B will receive treatment with 30mins manual lymphatic drainage twice weekly from an occupational therapist or physiotherapist and will be requested to complete the same sequence for 30min once daily at home. The duration of the intervention is 6 weeks. Irrespective of group allocation, participants will also be educated about head and neck lymphoedema and will receive a program of active exercises. Exercises will involve active range of motion movements of the face (contraction and relaxation of the lips, nose and eyes), neck (bending forwards, backwards, turning to the side and tilting to the side), and shoulders (circles and rotations) and participants will be requested to complete these 5-10 times per session for 2 sessions per day for the 6 weeks of the program. The exercises will be completed by the participant alone as a part of their self management training. During the first treatment session all participants will receive 1-1 training in self management for active exercises and either compression or manual lymphatic drainage. They will also receive written instructions to guide this self management. Self management training will be reviewed at each therapy appointment. Participants will be requested to monitor their adherence to self-management in a diary. Fidelity of the intervention (attended sessions, intervention delivered) will be recorded by the treating team. Between weeks 6-12 participants will continue self management as required. All participants will attend a 12 week follow up face-to-face assessment. This will be the last data collection point although participants may continue to receive therapy at the Princess Alexandra Hospital Lymphoedema Service if clinically indicated. During the trial, participants who wish to withdraw will be offered standard combined modality therapy through the Princess Alexandra Hospital Lymphoedema Service.
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• >18 years of age • A previous diagnosis of oral, nasopharyngeal, oropharyngeal, laryngeal, or hypopharyngeal cancer treated with chemoradiation, postoperative radiation or definitive radiation with curative intent • Life expectancy >12months • Able to provide informed written consent • MD Anderson Cancer Centre (MDACC) HNL rating >1 indicating soft visible oedema; no pitting, reversible
Exclusion criteria
• Cancer recurrence • Previous radiotherapy and/or surgery to the neck, oral, pharyngeal, or laryngeal anatomic structures • Pharyngolaryngectomy or laryngectomy • Co-morbidity factors that may result in head and neck oedema and/or lymphoedema, or impact their swallowing and voice function; such as stroke, head and neck trauma, or neurological degenerative diseases. • Unable to attend follow up appointments at the study site • Facial hair precluding completion of external lymphoedema assessment • NIRFLI imaging only: Allergic to indocyanine green, sodium iodide or iodine, over-active thyroid, benign tumours of the thyroid, previous known side effects from indocyanine green injections, kidney failure.
Outcome results
None listed