Central SensitizationNCT06418399
The Role of Central Sensitization in Pain, Functionality, and Quality of Life in Cancer Patients
An observational study of Central Sensitization, run by Marmara University.
Trial summary
Pain is one of the most important and challenging symptoms in cancer patients. Depending on the stage of cancer, approximately 40% to 70% of patients complain of pain. With the increasing lifespan of cancer patients due to developing treatments, pain palliation has become even more crucial to improve their quality of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Central Sensitization
- What is being tested?
- cancer patients
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 1 Apr 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included.
Who may be able to join
- Aged between 18 and 80 years
- Diagnosis of cancer confirmed pathologically
- Experiencing cancer or cancer treatment-related pain complaints for more than 3 months
Who cannot join
- 1.Patients with chronic pain not related to cancer will be excluded from the study 2.Patients who do not provide consent to participate in the study 3.Patients with conditions such as dementia, traumatic brain injury, advanced psychiatric disorders (schizophrenia, etc.), chromosomal disorders (Down syndrome), genetic diseases (fragile X syndrome), and neurodegenerative diseases that may lead to mental disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Pain is one of the most important and challenging symptoms in cancer patients. Depending on the stage of cancer, approximately 40% to 70% of patients complain of pain. With the increasing lifespan of cancer patients due to developing treatments, pain palliation has become even more crucial to improve their quality of life. Cancer-related pain can develop through multiple mechanisms such as the tumor itself, metastasis, or the methods used in treatment. The type of pain can be nociceptive, neuropathic, or mixed.
Central sensitization refers to the increased response of central nervous system nociceptive neurons to normal or subthreshold stimuli. Recently, central sensitization (CS) has been recognized as a potential pathophysiological mechanism underlying a group of chronic pain diseases such as fibromyalgia, temporomandibular joint disorder, irritable bowel syndrome, interstitial cystitis, tension-type headache, and chronic low back pain. Since pain perception varies from person to person, physicians should assess the character of pain thoroughly and not rely solely on peripheral pain treatment in cases with a component of central sensitization. The lack of evaluation of the extent to which central sensitization affects patients and the failure to fully determine the factors influencing it appear to be clinical limitations for now.
There are studies suggesting that central sensitization may be a significant factor in chronic refractory pain in cancer patients, indicating the need for consideration of alternative options to classical treatments. To the best of our knowledge, no study has been conducted in Turkey to investigate the frequency of central sensitization and its impact on treatment outcomes in chronic cancer pain patients visiting outpatient clinics. The aim of this study is to investigate the frequency of central sensitization and its effect on pain and quality of life in chronic cancer pain patients attending algology clinics in multiple centers in Turkey.
- Conditions
- Central Sensitization
- Being tested
- cancer patients
- Keywords
- Central Sensitization, cancer patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cancer patientsOther
Patients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included.
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of central sensitization in cancer patients can be determined.
Central sensitization is a common condition in cancer patients and has negative consequences on pain, functionality, and quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start20 May 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Central SensitizationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Savaş Şencan, Assoc. Prof., Study director, Marmara University Faculty of Medicine, Department of Pain MedicineSerdar Kokar, Assoc. Prof., Study director, Marmara University Faculty of Medicine, Department of Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418399
- Sponsor's protocol ID
- 22.04.2024.354
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is planned as multicenter, and data transfer will be conducted with other centers.
Publications
Bouhassira D, Luporsi E, Krakowski I. Prevalence and incidence of chronic pain with or without neuropathic characteristics in patients with cancer. Pain. 2017 Jun;158(6):1118-1125. doi: 10.1097/j.pain.0000000000000895.
PubMed 28267066Petersel DL, Dror V, Cheung R. Central amplification and fibromyalgia: disorder of pain processing. J Neurosci Res. 2011 Jan;89(1):29-34. doi: 10.1002/jnr.22512.
PubMed 20936697Smart KM, Blake C, Staines A, Thacker M, Doody C. Mechanisms-based classifications of musculoskeletal pain: part 1 of 3: symptoms and signs of central sensitisation in patients with low back (+/- leg) pain. Man Ther. 2012 Aug;17(4):336-44. doi: 10.1016/j.math.2012.03.013. Epub 2012 Apr 23.
PubMed 22534654Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
PubMed 20961685Nishigami T, Manfuku M, Lahousse A. Central Sensitization in Cancer Survivors and Its Clinical Implications: State of the Art. J Clin Med. 2023 Jul 11;12(14):4606. doi: 10.3390/jcm12144606.
PubMed 37510721
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Central Sensitization in Pain, Functionality, and Quality of Life in Cancer Patients
- ClinicalTrials.gov ID
- NCT06418399
- Acronym / sponsor ID
- 22.04.2024.354
- Conditions
- Central Sensitization
- Keywords
- Central Sensitization, cancer patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain is one of the most important and challenging symptoms in cancer patients. Depending on the stage of cancer, approximately 40% to 70% of patients complain of pain. With the increasing lifespan of cancer patients due to developing treatments, pain palliation has become even more crucial to improve their quality of life. Cancer-related pain can develop through multiple mechanisms such as the tumor itself, metastasis, or the methods used in treatment. The type of pain can be nociceptive, neuropathic, or mixed.
Central sensitization refers to the increased response of central nervous system nociceptive neurons to normal or subthreshold stimuli. Recently, central sensitization (CS) has been recognized as a potential pathophysiological mechanism underlying a group of chronic pain diseases such as fibromyalgia, temporomandibular joint disorder, irritable bowel syndrome, interstitial cystitis, tension-type headache, and chronic low back pain. Since pain perception varies from person to person, physicians should assess the character of pain thoroughly and not rely solely on peripheral pain treatment in cases with a component of central sensitization. The lack of evaluation of the extent to which central sensitization affects patients and the failure to fully determine the factors influencing it appear to be clinical limitations for now.
There are studies suggesting that central sensitization may be a significant factor in chronic refractory pain in cancer patients, indicating the need for consideration of alternative options to classical treatments. To the best of our knowledge, no study has been conducted in Turkey to investigate the frequency of central sensitization and its impact on treatment outcomes in chronic cancer pain patients visiting outpatient clinics. The aim of this study is to investigate the frequency of central sensitization and its effect on pain and quality of life in chronic cancer pain patients attending algology clinics in multiple centers in Turkey.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included.
Key inclusion criteria (3 listed)
- Aged between 18 and 80 years
Key exclusion criteria (1 listed)
- 1.Patients with chronic pain not related to cancer will be excluded from the study 2.Patients who do not provide consent to participate in the study 3.Patients with conditions such as dementia, traumatic brain injury, advanced psychiatric disorders (schizophrenia, etc.), chromosomal disorders (Down syndrome), genetic diseases (fragile X syndrome), and neurodegenerative diseases that may lead to mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cancer patientsPatients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included. | Other | – |
Primary outcome
The frequency of central sensitization in cancer patients can be determined.
Time frame: 1 year
Central sensitization is a common condition in cancer patients and has negative consequences on pain, functionality, and quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 28267066Bouhassira D, Luporsi E, Krakowski I. Prevalence and incidence of chronic pain with or without neuropathic characteristics in patients with cancer. Pain. 2017 Jun;158(6):1118-1125. doi: 10.1097/j.pain.0000000000000895.
- Background: PubMed 20936697Petersel DL, Dror V, Cheung R. Central amplification and fibromyalgia: disorder of pain processing. J Neurosci Res. 2011 Jan;89(1):29-34. doi: 10.1002/jnr.22512.
- Background: PubMed 22534654Smart KM, Blake C, Staines A, Thacker M, Doody C. Mechanisms-based classifications of musculoskeletal pain: part 1 of 3: symptoms and signs of central sensitisation in patients with low back (+/- leg) pain. Man Ther. 2012 Aug;17(4):336-44. doi: 10.1016/j.math.2012.03.013. Epub 2012 Apr 23.
- Background: PubMed 20961685Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
- Background: PubMed 37510721Nishigami T, Manfuku M, Lahousse A. Central Sensitization in Cancer Survivors and Its Clinical Implications: State of the Art. J Clin Med. 2023 Jul 11;12(14):4606. doi: 10.3390/jcm12144606.
- Individual participant dataSharing planned: Undecided. The study is planned as multicenter, and data transfer will be conducted with other centers.
Related trials for Central Sensitization
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
RecruitingObservational study
Postoperative Pain Trajectories After Endometriosis Surgery
Endometriosis, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savaş Şencan, Assoc. Prof. study director
Marmara University Faculty of Medicine, Department of Pain Medicine
Serdar Kokar, Assoc. Prof. study director
Marmara University Faculty of Medicine, Department of Pain Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sensitization, run by Marmara University.
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 1 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savaş Şencan, Assoc. Prof. (5370665713 ext. +90, savas-44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of central sensitization in cancer patients can be determined. (time frame: 1 year). 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 NCT06418399, which also lists 5 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 17 May 2024.