Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)
NCT ID: NCT04145180
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
55 participants
INTERVENTIONAL
2019-09-02
2022-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness
NCT03089736
Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms
NCT01274806
Return to Work and Living Healthy After Head and Neck Cancer
NCT03065634
Influencing Factors for Physical Activity in People With Head and Neck Cancer
NCT06272513
Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population
NCT01910753
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Manual Therapy
Manual Therapy-based intervention
Manual therapy
40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.
Control
Patients waiting list
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Manual therapy
40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* To have no metastasis or active cancer
* To have cervical and/or temporomandibular joint pain \>3 in a Visual Analogue Scale
Exclusion Criteria
* Previous chronic pain conditions
* Previous cervical or temporomandibular joint pain
* Previous dysphagia disorders
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Granada
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carolina Fernández Lao
Dr. Carolina Fernández-Lao
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carolina Fernández-Lao, PhD
Role: STUDY_CHAIR
Universidad de Granada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Carolina Fernández Lao
Granada, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0045-N-16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.