RELIEF-HNC: Is complete decongestive theRapy a fEasibLe and acceptable IntervEntion for patients with lymphoedema Following treatment for Head and Neck Cancer?
Head and neck cancer
Study design This project comprises three workstreams: 1. Systematic review to inform intervention development 2. Co-production workshops using a Living Labs approach to design and refine the intervention 3. A single-centre randomised feasibility study comparing a personalised complete decongestive therapy (CDT) intervention with usual care in patients with head and neck lymphoedema (HNL) following head and neck cancer treatment Randomisation Participants in the feasibility study are randomised after providing informed consent. Randomisation method: • Telephone-based digital randomisation system • Allocation occurs after consent is obtained • Participants randomised to the control arm are referred to the local community-based lymphoedema service No sealed-envelope process is described. Intervention arm Participants receive a structured but individualised 3-month CDT programme delivered by a trained speech and language therapist who is also a certified lymphoedema therapist. The intervention includes four core CDT components: 1. Manual lymphatic drainage (MLD), including intra-oral and external techniques tailored to the individual's lymphoedema profile 2. Compression therapy using chin straps, customised pads, garments, or kinesiotape where appropriate 3. Skin care education and management 4. Therapeutic exercises, including swallowing exercises Intervention schedule: • Baseline videofluoroscopy assessment (approximately 1 hour) • Baseline assessment and development of an individualised CDT programme (approximately 2 hours) • Provision of personalised compression garments and self-management materials where indicated • Daily home programme of MLD and exercises • Compression therapy at least 3 times per week, daily if tolerated • Follow-up review at 1 week (approximately 30 minutes) • Final review and repeat assessments at 3 months (approximately 2-3 hours) Participants also receive written self-management resources and routine clinical follow-up. Control arm
1. Patients with a HNC diagnosis 2. Patients presenting with Stage 1a oedema or above. Surgical patients at least 8 weeks post treatment 3. Oncology patients at least 8 weeks post chemo-radiation. 50 Gy or higher dose of radiation to bilateral neck and primary tumour site in 30 or more fractions 4. Aged 18 years or older 5. All genders
1. Medical contraindications 2. Patients with active/recurrent HNC disease 3. Patient who are unable to provide informed consent 4. Patients with head and neck lymphedema from non cancer aetiologies