Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy (ReDyOR)

Parc de Salut Mar

Status: Completed

Conditions: Cancer of Head and Neck

Treatments: Other: Late rehabilitation; Other: Early rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02900911

2014/5707/l

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Early rehabilitation

Experimental group

Description:

Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months

Treatment:

Other: Early rehabilitation

Later rehabilitation

Active Comparator group

Description:

Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy

Treatment:

Other: Late rehabilitation