NCT06418399

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

May 13, 2024

Last Update Submit

May 13, 2024

Conditions

Keywords

Central Sensitizationcancer patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Interventions

Patients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included.

You may qualify if:

  • Aged between 18 and 80 years
  • Diagnosis of cancer confirmed pathologically
  • Experiencing cancer or cancer treatment-related pain complaints for more than 3 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 28267066BACKGROUND
  • Petersel 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.

    PMID: 20936697BACKGROUND
  • Smart 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.

    PMID: 22534654BACKGROUND
  • Woolf 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.

    PMID: 20961685BACKGROUND
  • Nishigami 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.

    PMID: 37510721BACKGROUND

Study Officials

  • Savaş Şencan, Assoc. Prof.

    Marmara University Faculty of Medicine, Department of Pain Medicine

    STUDY DIRECTOR
  • Serdar Kokar, Assoc. Prof.

    Marmara University Faculty of Medicine, Department of Pain Medicine

    STUDY DIRECTOR

Central Study Contacts

Savaş Şencan, Assoc. Prof.

CONTACT

Ronay Bozyel, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 17, 2024

Study Start

May 20, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05