Clinical trial NCT02900911: Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy
Official title: Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Keywords: head and neck cancer
dysphagia
rehabilitation
radiation therapy
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Asociación Española contra el Cáncer
First posted: 2016-09-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced head and neck cancer receiving radiotherapy

Exclusion Criteria:

* Candidates to surgical treatment
* Previous head and neck cancer
* Dysphagia due to causes other than cancer
* Previous head or neck radiation therapy.

Primary outcomes:
measure: Change in dysphagia severity at three months post radiotherapy
timeFrame: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
measure: Change in quality of life at three months post radiotherapy
timeFrame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Secondary outcomes:
measure: Change in dysphagia security signs at three months post radiotherapy
timeFrame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
measure: Change in lingual Force at three months post radiotherapy
timeFrame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de l'Esperança
Study officials:
References:
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