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Head and Neck Cancer3C-CUIDATENCT04145180

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

A study testing Manual therapy in people with Head and Neck Cancer and Pain, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Cancer, Pain, Dysfunction
What is being tested?
Manual therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteSpain
Study dates
2 Sep 2019to 30 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Carolina Fernández Lao

    Granada, 18014

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
Manual therapy
Keywords
Pain, Function, Quality of Life, Head and Neck Cancer
Medical subject headings
Head and Neck Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual therapyOther

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

Study groups in NCT04145180
Study groupRoleWhat they receive
Manual TherapyExperimentalManual Therapy-based intervention
Receives: Other: Manual therapy
ControlNo interventionPatients waiting list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life

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

    Measured: 6 weeks

  2. Health-related quality of life - 2

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

    Measured: 6 weeks

  3. Pain Intensity

    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)

    Measured: 6 weeks

  4. Pressure pain thresholds

    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.

    Measured: 6 weeks

  5. Shoulder and cervical active range of motion

    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)

    Measured: 6 weeks

Secondary outcomes (13)

  1. Shoulder pain and disability perception

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

    Measured: 6 weeks

  2. Isometric handgrip strength

    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.

    Measured: 6 weeks

  3. Deep cervical flexors endurance

    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.

    Measured: 6 weeks

  4. Physical Fitness

    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

    Measured: 6 weeks

  5. Maximal mouth opening

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

    Measured: 6 weeks

  6. Temporomandibular disorders

    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

    Measured: 6 weeks

  7. Perceived fatigue

    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.

    Measured: 6 weeks

  8. Fatigue

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

    Measured: 6 weeks

  9. Sleep quality

    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.

    Measured: 6 weeks

  10. Sleeping disorders

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

    Measured: 6 weeks

  11. Anxiety

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

    Measured: 6 weeks

  12. Swallowing function

    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

    Measured: 6 weeks

  13. Swallowing difficulty

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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start2 Sep 2019
  3. Primary completion20 Dec 2021
  4. Study completion30 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145180
Sponsor's protocol ID
0045-N-16
Acronym
3C-CUIDATE
Status last verified
Jan 2024
First submitted
9 Oct 2019
Last updated
9 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • De Groef A, Van Kampen M, Vervloesem N, Dieltjens E, Christiaens MR, Neven P, Vos L, De Vrieze T, Geraerts I, Devoogdt N. Effect of myofascial techniques for treatment of persistent arm pain after breast cancer treatment: randomized controlled trial. Clin Rehabil. 2018 Apr;32(4):451-461. doi: 10.1177/0269215517730863. Epub 2017 Sep 15.

    PubMed 28914087

  • Sheikh A, Shallwani H, Ghaffar S. Postoperative shoulder function after different types of neck dissection in head and neck cancer. Ear Nose Throat J. 2014 Apr-May;93(4-5):E21-6.

    PubMed 24817237

  • Oz B, Memis A. Development of musculoskeletal complaints and functional disabilities in patients with laryngeal carcinoma after neck dissection sparing spinal accessory nerve. Eur J Cancer Care (Engl). 2009 Mar;18(2):179-83. doi: 10.1111/j.1365-2354.2008.00950.x. No abstract available.

    PubMed 19267734

  • Binczak M, Navez M, Perrichon C, Blanchard D, Bollet M, Calmels P, Couturaud C, Dreyer C, Espitalier F, Testelin S, Albert S, Moriniere S; SFORL Work Group. Management of somatic pain induced by head-and-neck cancer treatment: definition and assessment. Guidelines of the French Oto-Rhino-Laryngology- Head and Neck Surgery Society (SFORL). Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Sep;131(4):243-7. doi: 10.1016/j.anorl.2014.07.003. Epub 2014 Aug 6.

    PubMed 25108356

  • Cantarero-Villanueva I, Fernandez-Lao C, Fernandez-de-Las-Penas C, Lopez-Barajas IB, Del-Moral-Avila R, de la-Llave-Rincon AI, Arroyo-Morales M. Effectiveness of water physical therapy on pain, pressure pain sensitivity, and myofascial trigger points in breast cancer survivors: a randomized, controlled clinical trial. Pain Med. 2012 Nov;13(11):1509-19. doi: 10.1111/j.1526-4637.2012.01481.x. Epub 2012 Sep 7.

    PubMed 22958507

  • Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

    PubMed 3785962

  • van Wilgen CP, Dijkstra PU, van der Laan BF, Plukker JT, Roodenburg JL. Shoulder and neck morbidity in quality of life after surgery for head and neck cancer. Head Neck. 2004 Oct;26(10):839-44. doi: 10.1002/hed.20052.

    PubMed 15390203

  • Cardoso LR, Rizzo CC, de Oliveira CZ, dos Santos CR, Carvalho AL. Myofascial pain syndrome after head and neck cancer treatment: Prevalence, risk factors, and influence on quality of life. Head Neck. 2015 Dec;37(12):1733-7. doi: 10.1002/hed.23825. Epub 2014 Sep 25.

    PubMed 24986588

  • Sist T, Miner M, Lema M. Characteristics of postradical neck pain syndrome: a report of 25 cases. J Pain Symptom Manage. 1999 Aug;18(2):95-102. doi: 10.1016/s0885-3924(99)00054-8.

    PubMed 10484856

  • Gane EM, Michaleff ZA, Cottrell MA, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. Prevalence, incidence, and risk factors for shoulder and neck dysfunction after neck dissection: A systematic review. Eur J Surg Oncol. 2017 Jul;43(7):1199-1218. doi: 10.1016/j.ejso.2016.10.026. Epub 2016 Nov 17.

    PubMed 27956321

  • Gane EM, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. The relationship between physical impairments, quality of life and disability of the neck and upper limb in patients following neck dissection. J Cancer Surviv. 2018 Oct;12(5):619-631. doi: 10.1007/s11764-018-0697-5. Epub 2018 May 16.

    PubMed 29770954

Questions about this trial

What is this clinical trial studying?

A study testing Manual therapy in people with Head and Neck Cancer and Pain, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04145180, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.

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