Clinical trial NCT04145180: Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)
Official title: 3C-CUIDATE: Efectividad de un Programa de Recuperación Física en el Tratamiento de Las Secuelas Musculoesqueléticas, Funcionales y de Calidad de Vida en Pacientes de Cáncer de Cabeza y Cuello.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Pain
Dysfunction
Keywords: Pain
Function
Quality of Life
Head and Neck Cancer
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People receiving a head and neck cancer treatment often do not find an adequate therapeutic response for the side effects derived from this treatment. The objective of this study is to assess the effectiveness of a physical recovery program based on manual therapy over these problems.

Previous studies have shown the effectiveness of this type of programs on patients who have had cancer in other locations with clinically relevant results. There is a shortage of proposals for this subgroup of patients that require special attention. This project intends to carry out an experimental randomized controlled study with 84 patients treated of head and neck cancer who will be assigned randomly to the study groups: a) manual therapy program or, b) control group. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 months of patient follow-up.

Detailed description: Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 months after finishing the treatment.

Eligibility criteria: Inclusion Criteria:

* To have ended their treatment in the previous 6-24 months
* To have no metastasis or active cancer
* To have cervical and/or temporomandibular joint pain \>3 in a Visual Analogue Scale

Exclusion Criteria:

* Mental or physical illness preventing subjects from participating in the study
* Previous chronic pain conditions
* Previous cervical or temporomandibular joint pain
* Previous dysphagia disorders

Primary outcomes:
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Health-related quality of life - 2
timeFrame: 6 weeks
measure: Pain Intensity
timeFrame: 6 weeks
measure: Pressure pain thresholds
timeFrame: 6 weeks
measure: Shoulder and cervical active range of motion
timeFrame: 6 weeks
Secondary outcomes:
measure: Shoulder pain and disability perception
timeFrame: 6 weeks
measure: Isometric handgrip strength
timeFrame: 6 weeks
measure: Deep cervical flexors endurance
timeFrame: 6 weeks
measure: Physical Fitness
timeFrame: 6 weeks
measure: Maximal mouth opening
timeFrame: 6 weeks
measure: Temporomandibular disorders
timeFrame: 6 weeks
measure: Perceived fatigue
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 6 weeks
measure: Sleep quality
timeFrame: 6 weeks
measure: Sleeping disorders
timeFrame: 6 weeks
measure: Anxiety
timeFrame: 6 weeks
measure: Swallowing function
timeFrame: 6 weeks
measure: Swallowing difficulty
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Carolina Fernández Lao
Study officials:
affiliation: Universidad de Granada
name: Carolina Fernández-Lao, PhD
role: STUDY_CHAIR
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