Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy
- Conditions
- Cancer of Head and Neck
- Interventions
- Other: Late rehabilitationOther: Early rehabilitation
- Registration Number
- NCT02900911
- Lead Sponsor
- Parc de Salut Mar
- Brief Summary
Head and neck cancer has a negative impact in swallowing function and quality of life. Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions. This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.
- Detailed Description
Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.
Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.
Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Patients with advanced head and neck cancer receiving radiotherapy
- Candidates to surgical treatment
- Previous head and neck cancer
- Dysphagia due to causes other than cancer
- Previous head or neck radiation therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Later rehabilitation Late rehabilitation Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy Early rehabilitation Early rehabilitation Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
- Primary Outcome Measures
Name Time Method Change in dysphagia severity at three months post radiotherapy 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy 8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and \>6, aspiration
Change in quality of life at three months post radiotherapy 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy Head \& Neck Cancer 35 (HN35)
- Secondary Outcome Measures
Name Time Method Change in dysphagia security signs at three months post radiotherapy 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) assessed with the Volume Viscosity Swallow Test
Change in lingual Force at three months post radiotherapy 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.
Trial Locations
- Locations (1)
Hospital de l'Esperança
🇪🇸Barcelona, Spain