Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment.

NCT05507034 | Unknown

• 1 other identifier: 1780
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 40% of women experience chronic pain after treatment for breast cancer, and this pain is often very disabling. However, chronic pain after breast cancer remains under-recognised and undertreated. An effective and patient-tailored approach of (chronic) pain after breast cancer indeed requires a thorough knowledge and evaluation of the pain. In daily clinical practice, however, guidelines for a comprehensive diagnosis of pain in cancer patients and survivors are lacking. Further research in this topic is crucial for an efficient, preventive as well as curative, approach of pain after breast cancer. Besides the high prevalence and the important impact of pain in this population, the breast cancer population is also an ideal population to study chronic pain and its natural time course in different stages, since most patients start pain-free, but almost half of them end up with chronic pain. Therefore, this study aims to map biomarkers (both predictive, prognostic and diagnostic) for chronic pain after breast cancer treatment. We will study possible biopsychosocial biomarkers in relation to (chronic) pain and monitor their temporal changes from the moment of diagnosis until 1 year after surgery. The potential biomarkers are situated within the medical imaging of the brain, measurements of pain sensitivity and psychological variables.

Conditions

Neoplasm, Breast; Carcinoma Breast; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Localisation of pain

  Localisation and experience of pain after cancer treatment measured with the Mc Gill Pain Questionnaire Dutch Language Version: Anamnesis questions to localize the pain and the experience of the patient. Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

  Time frame up to 1 year post-surgery

• Pain intensity

  Visual Analogue Scale included in the Mc Gill Pain Questionnaire is a 100mm horizontal line were the patient is asked to indicate his/her perceived pain intensity at this moment, the minimum and the maximum of the pain. Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

  Time frame up to 1 year post-surgery

• Influence of pain on the quality of life

  Quality of Life questions included in the Mc Gill Pain Questionnaire: self-report to indicate the impact of pain on quality of life. The higher the score the higher the impact (0-27). Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

  Time frame up to 1 year post-surgery

• Severity of pain symptoms

  Adjective list of pain symptoms included in the Mc Gill Pain Questionnaire Dutch : Language Version (0-63): Self-report of pain evaluating the sensory intensity, emotional impact and the cognitive evaluation of pain. Each part or dimension of the MPQ is individually scored and a cumulative total score is also recorded. Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

  Time frame up to 1 year post-surgery

Secondary Outcomes (14)

• Prognostic value of Pain Catastrophizing

  Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

• Prognostic value of Depression, Anxiety and Stress

  Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

• Prognostic value of Positive and Negative affect

  Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

• Prognostic value of Resilience

  Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

• Prognostic value of hyperalgesia

  Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery

Study Arms (1)

Breast cancer

Breast cancer patients following over time during cancer treatment

Diagnostic Test: Biomarkers

Interventions

Biomarkers DIAGNOSTIC_TEST

Each intervention is performed at 4 timepoints namely: before surgery, i.e. baseline (T0), 1-3 weeks post-surgery (T1), 3 months post-surgery (T2) and 1 year post-surgery (T4)

Also known as: Questionnaires: Depression Anxiety Stress Scales Short form, Pain Catastrophising Scale, VK+ and Positive and Negative Affect Schedule, Quantitative sensory testing: hyperalgesia using TSA2 (Medoc), Conditioned Pain Modulation using TSA2 (Medoc), Temporal Summation using monofilament (256mN Optihair-2 Set) and TSA2 (Medoc), Brain imaging: T1 MPRAGE, rsfMRI, Diffusion Weighted Image and T2 sequence., Blood analysis: Cytokine and Brain-Derived Neurotrophic Factor expression measurements, SNPs and CpG methylation detection.

Breast cancer

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients diagnosed with unilateral breast cancer

You may qualify if:

• Unilateral breast cancer
• Pain at enrollment \<3/10 on average during the past week
• First cancer diagnosis

You may not qualify if:

• Pre-existing pain conditions
• major pre-existing neurological disorders
• No recurrent cancer or metastasis
• No previous surgery in area

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

University Hospital Antwerpen

Wilrijk, Antwerpen, 2610, Belgium

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain

Interventions

Environmental Biomarkers; Gene Expression; Polymorphism, Single Nucleotide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health; Genetic Phenomena; Polymorphism, Genetic; Genetic Variation

Study Officials

• Mira Meeus, Prof.

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• An De Groef, Prof.

  Universiteit Antwerpen

  STUDY CHAIR

Central Study Contacts

Mira Meeus, Prof.

CONTACT

+32 3 265 2403; mira.meeus@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: August 18, 2022
• Study Start: October 4, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

BE (1)