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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04145180
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : November 6, 2020
Information provided by (Responsible Party):
Carolina Fernández Lao, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Pain Dysfunction Other: Manual therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Manual Therapy
Manual Therapy-based intervention
Other: Manual therapy
40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.

No Intervention: Control
Patients waiting list

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04145180

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Contact: Carolina Fernández-Lao, PhD 0034665879315
Contact: Lucía Ortiz-Comino, MSc 0034600889438

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Carolina Fernández Lao Recruiting
Granada, Spain, 18014
Contact: Carolina Fernández Lao, PhD    0034665879315   
Sub-Investigator: Lucía Ortiz-Comino         
Principal Investigator: Carolina Fernández-Lao         
Sub-Investigator: Lydia Martín-Martín         
Sponsors and Collaborators
Universidad de Granada
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Study Chair: Carolina Fernández-Lao, PhD Universidad de Granada

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Responsible Party: Carolina Fernández Lao, Dr. Carolina Fernández-Lao, Universidad de Granada Identifier: NCT04145180    
Other Study ID Numbers: 0045-N-16
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carolina Fernández Lao, Universidad de Granada:
Quality of Life
Head and Neck Cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site