Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment.

NCT ID: NCT05507034

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-04

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasm, Breast Carcinoma Breast Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer

Breast cancer patients following over time during cancer treatment

Biomarkers

Intervention Type 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)

Interventions

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Biomarkers

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)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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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.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pre-existing pain conditions
* major pre-existing neurological disorders
* No recurrent cancer or metastasis
* No previous surgery in area
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. Mira Meeús

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mira Meeus, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

An De Groef, Prof.

Role: STUDY_CHAIR

Universiteit Antwerpen

Locations

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University Hospital Antwerpen

Wilrijk, Antwerpen, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Mira Meeus, Prof.

Role: CONTACT

Phone: +32 3 265 2403

Email: [email protected]

Facility Contacts

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Amber De Groote, Drs.

Role: primary

Related Links

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Other Identifiers

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1780

Identifier Type: -

Identifier Source: org_study_id