Clinical Classification of Pain in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Clinical Classification of Pain in Breast Cancer Survivors: Nociceptive, Neuropathic or Nociplastic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219072
• Other study ID #: KutahyaMSUcancer
• Status: Completed
• Start date: July 1, 2023
• Est. completion date: October 28, 2023

Study information

• Verified date: November 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer is the most common malignancy in women worldwide according to International Agency for Research on Cancer. Unfortunately, cancer survivors often face long-term symptoms that occur or persist after completion of treatment. In addition to fatigue, pain is the most common persistent symptom after cancer and cancer treatment. The diagnosis and treatment of pain in cancer survivors is not clear for many physicians. A mechanism-based classification of pain in cancer survivors might be a critical step for clinical reasoning, especially for discrimination of different pain types. The primary aim of this study is to determine the prevalence of the predominant type of pain in Turkish breast cancer survivors using a recent published clinical algorithm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 28, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosed with histologically confirmed invasive or non-invasive primary breast cancer

• completed remission and their primary treatment at least 3 months prior to study participation

• experienced pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 3 on a numeric pain rating scale

Exclusion Criteria:

• patients affected by other chronic disease,

• severe psychological disorders

• active metastases

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Pain
• Chronic Pain
• Mastodynia

Locations

Country	Name	City	State
Turkey	KutahyaMSU	Kütahya	Kutahya Health Sciences University

Sponsors (2)

Lead Sponsor	Collaborator
Kutahya Health Sciences University	Vrije Universiteit Brussel

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale	The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	1 minute
Primary	Margolis Pain Diagram	The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours	5 minute
Primary	Central Sensitization Inventory	The Central Sensitization Inventory (CSI) aims to evaluate symptoms thought to be associated with nociplastic pain. The CSI consists 25 items exploring emotional and somatic disorders associated with CS. Each response is scored from 0 to 4, yielding a total score of 0 to 100. A score of 40 or higher on the CSI means the presence of nociplastic pain.	10 minute
Primary	Short Form 36	The Short Form-36 (SF-36) is widely used to measurement of health related quality of life (HRQoL) questionnaire. SF-36 is a 36-item generic self-administered instrument consisting of 8 subscales related to various aspects of HRQoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The 8 subscales are scored from 0 to 100, with higher scores indicating better health status.	10 minute
Secondary	Quantitative sensory test	Quantitative sensory testing (QST) is a psychophysical method used to quantify somatosensory function in patients. In QST will be used various stimuli static thermal (thermotest), static mechanical ( a painter brush), pinprick (a calibrated pin) and vibration ( a tuning folk). QST will interrogate whether each stimulus is considered a sensory loss (negative sign) or sensory gain (positive sign or hyperalgesia).	10 minute