Skip to main content
OpenTrials
Completed

NCT Number: NCT04145180

Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Fernández Lao

Granada, 18014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual therapy

Other

40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.

Primary outcomes

  1. Health-related quality of life

    Time frame: 6 weeks

    Questionnaire EORTC QLQ-C30 was used for measuring quality of life

  2. Health-related quality of life - 2

    Time frame: 6 weeks

    Questionnaire EORTC QLQ-H&N-35 was used for measuring quality of life specifically in survivors of head and neck cancer

  3. Pain Intensity

    Time frame: 6 weeks

    Visual Analogue Scale was used for evaluating pain intensity at cervical, temporomandibular joint, face and shoulder levels bilaterally.

    This consisted of a 10 cm horizontal line with the words "no pain" at the left extreme (0) and "pain as bad as it could be" at the right extreme (10)

  4. Pressure pain thresholds

    Time frame: 6 weeks

    Pressure algometry (Force Dial DFK 20 analogue algometer, Wagner, Greenwich, USA) was assessed over the temporalis, masseter, upper trapezius and levator scapulae muscles and the C5-C6 zygapophyseal joint, the sternoclavicular joint and the tibialis anterior muscle as a distant reference muscle.

  5. Shoulder and cervical active range of motion

    Time frame: 6 weeks

    Shoulder active range of motion (AROM) was assessed with a two-arms goniometer joined by a 360º protractor with the patient lying on a supine position. Cervical AROM was measured in a upright sitting position with a range of motion instrument (Performance Attainment Associates, Spine Products)

Secondary outcomes

  1. Shoulder pain and disability perception

    Time frame: 6 weeks

    Shoulder pain and disability index (SPADI) was used to evaluate pain and disability perception of the patients at shoulder level.

  2. Isometric handgrip strength

    Time frame: 6 weeks

    A digital dynamometer with adjustable grip (TKK 5101 Grip-D; Takei, Tokyo, Japan) was used to assess handgrip strength. Patients were standing in a upright position with the elbow in complete extension. Test was performed 3 times per hand, alternating both hands, with a 1-minute rest between trials.

  3. Deep cervical flexors endurance

    Time frame: 6 weeks

    Endurance of deep cervical flexor muscles was assessed with the deep cervical flexor endurance test, with the patient in a supine lying position with the examiner's hands under his/her head and being told to fold the chin completely to the sternum and raising the head as minimum as possible without touching examiner's hands. Time is counted from when the patient lift his/her head until when he/she can no longer maintain the position.

  4. Physical Fitness

    Time frame: 6 weeks

    International Fitness Scale (IFIS) was used to evaluate perceived physical fitness. It contains 4 physical fitness elements (cardiorespiratory endurance, muscular strength, speed/agility and flexibility) to categorize into 5 options, from very poor to very good

  5. Maximal mouth opening

    Time frame: 6 weeks

    Mouth opening was evaluated with a sliding calliper measuring the inter-incisor distance asking the patients to open the mouth as maximum as possible

  6. Temporomandibular disorders

    Time frame: 6 weeks

    The presence of temporomandibular disorders (TMD) was assessed with the Fonseca Anamneses Index, that classifies TMD as no dysfunction, light dysfunction, moderate dysfunction or severe dysfunction

  7. Perceived fatigue

    Time frame: 6 weeks

    Piper Fatigue Scale - revised (PFS-r) was used to measure fatigue perception in head and neck cancer patients. It consists of 22 items divided into 4 subscales: behaviour, affection, emotional and cognitive. Each item is evaluated in a Visual Analogue Scale ranging from 0 to 10.

  8. Fatigue

    Time frame: 6 weeks

    Fatigue perceived at the assessment moment was measured with a Visual Analogue Scale ranging from 0)no fatigue to 10) maximum fatigue perceived

  9. Sleep quality

    Time frame: 6 weeks

    To evaluate sleep quality, Pittsburgh Sleep Quality Index (PSQI) was the instrument used. It consists of 19 self-rated questions related to sleep quality, including estimates of sleep duration and latency and the frequency and severity of specific sleep-related problems.

  10. Sleeping disorders

    Time frame: 6 weeks

    Sleeping disorders were evaluated with a Visual Analogue Scale rating from 0)no disturbances to 10)impossible to sleep

  11. Anxiety

    Time frame: 6 weeks

    Perception of anxiety at the assessment moment was measured with a Visual Analogue Scale rating from 0)no anxiety to 10)maximum anxiety perceived

  12. Swallowing function

    Time frame: 6 weeks

    Eating Assessment Tool (EAT-10) was used to evaluate self-reported swallowing impairments. It is a 5 point Likert scale rating from no impairment to severe problem. The sum of all items contained on the questionnaire is used as the overall score, suggesting an abnormal swallowing when score is higher than 3

  13. Swallowing difficulty

    Time frame: 6 weeks

    A Visual Analogue Scale was used to register swallowing difficulties, ranging from 0)no problems to 10)impossible to swallow

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study 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.

Acronym: 3C-CUIDATE

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 30, 2019
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.