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Trial Title:
Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment.
NCT ID:
NCT05507034
Condition:
Neoplasm, Breast
Carcinoma Breast
Chronic Pain
Conditions: Official terms:
Breast Neoplasms
Chronic Pain
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Biomarkers
Description:
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)
Arm group label:
Breast cancer
Other name:
Questionnaires: Depression Anxiety Stress Scales Short form, Pain Catastrophising Scale, VK+ and Positive and Negative Affect Schedule
Other name:
Quantitative sensory testing: hyperalgesia using TSA2 (Medoc), Conditioned Pain Modulation using TSA2 (Medoc), Temporal Summation using monofilament (256mN Optihair-2 Set) and TSA2 (Medoc)
Other name:
Brain imaging: T1 MPRAGE, rsfMRI, Diffusion Weighted Image and T2 sequence.
Other name:
Blood analysis: Cytokine and Brain-Derived Neurotrophic Factor expression measurements, SNPs and CpG methylation detection.
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.
Criteria for eligibility:
Study pop:
Female patients diagnosed with unilateral breast cancer
Sampling method:
Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Antwerpen
Address:
City:
Wilrijk
Zip:
2610
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Amber De Groote, Drs.
Start date:
October 4, 2022
Completion date:
June 2025
Lead sponsor:
Agency:
Universiteit Antwerpen
Agency class:
Other
Collaborator:
Agency:
University Hospital, Antwerp
Agency class:
Other
Collaborator:
Agency:
Fund for Scientific Research, Flanders, Belgium
Agency class:
Other
Source:
Universiteit Antwerpen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05507034
https://www.caredon.org/researchers/projects/biomarkers-pain
