Clinical trial NCT05507034: Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment.
Official title: sCANsens: Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasm, Breast
Carcinoma Breast
Chronic Pain
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Fund for Scientific Research, Flanders, Belgium
First posted: 2022-08-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients diagnosed with unilateral breast cancer

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.


Eligibility 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

Primary outcomes:
measure: Localisation of pain
timeFrame: Time frame up to 1 year post-surgery
measure: Pain intensity
timeFrame: Time frame up to 1 year post-surgery
measure: Influence of pain on the quality of life
timeFrame: Time frame up to 1 year post-surgery
measure: Severity of pain symptoms
timeFrame: Time frame up to 1 year post-surgery
Secondary outcomes:
measure: Prognostic value of Pain Catastrophizing
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of Depression, Anxiety and Stress
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of Positive and Negative affect
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of Resilience
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of hyperalgesia
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of conditioned pain modulation
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of temporal summation
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of gray matter differences
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of functional connectivity
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of Fractional Anisotropy
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of the percentage CpG methylation in gene regions of selected cytokine and Brain Derived Neurotrophic Factor genes.
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of cytokine expression
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of Brain Derived Neurotrophic factor expression
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
measure: Prognostic value of single nucleotide polymorphisms (SNPs)
timeFrame: Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: University Hospital Antwerpen
state: Antwerpen
Study officials:
affiliation: Universiteit Antwerpen
name: Mira Meeus, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: An De Groef, Prof.
role: STUDY_CHAIR
References: