## Protocol Section
### Identification Module
**NCT ID:** NCT06418399

**Brief Title:** The Role of Central Sensitization in Pain, Functionality, and Quality of Life in Cancer Patients

**Official Title:** The Role of Central Sensitization in Pain, Functionality, and Quality of Life in Cancer Patients

#### Organization Study ID Info
**ID:** 22.04.2024.354
#### Organization
**Class:** OTHER
**Full Name:** Marmara University
### Status Module
#### Completion Date
**Date:** 2025-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Marmara University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Central Sensitization

**Keywords:**

- Central Sensitization

- cancer patients

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Year

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** cancer patients

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Central sensitization is a common condition in cancer patients and has negative consequences on pain, functionality, and quality of life.

**Measure:** The frequency of central sensitization in cancer patients can be determined.

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged between 18 and 80 years

  1. Diagnosis of cancer confirmed pathologically
  2. Experiencing cancer or cancer treatment-related pain complaints for more than 3 months

Exclusion Criteria:

* 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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** savas-44@hotmail.com

**Name:** Savaş Şencan, Assoc. Prof.

**Phone:** 5370665713

**Phone Ext:** +90

**Role:** CONTACT

**Contact 2:**

**Email:** ronaybozyel@gmail.com

**Name:** Ronay Bozyel, M.D.

**Phone:** 5392320689

**Phone Ext:** +90

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Marmara University Faculty of Medicine, Department of Pain Medicine

**Name:** Savaş Şencan, Assoc. Prof.

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Marmara University Faculty of Medicine, Department of Pain Medicine

**Name:** Serdar Kokar, Assoc. Prof.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** The study is planned as multicenter, and data transfer will be conducted with other centers.

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** 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:** 28267066

**Citation:** 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:** 20936697

**Citation:** 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:** 22534654

**Citation:** 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:** 20961685

**Citation:** 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:** 37510721

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Misc Info Module

- Version Holder: 2024-05-31
