Determination of central pain modulation biomarkers to characterize and profile cancer patients with refractory pain

Registry ID
ISRCTN35887998
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Santiago de Compostela
Enrollment
750
Start date
2024-02-20
Completion date
2027-11-30
Last update
2026-08-17

Conditions

Summary

Assessment of cancer pain in patients with breast, pancreatic, lung, colon or prostate cancer.

Detailed description

This study will measure different variables (pain biomarkers and moderating variables) at a single time point (baseline; cross-sectional study) to compare cancer patients with cancer pain and those without pain and characterize and profile cancer patients with refractory pain (case versus control). This study attempts to improve the knowledge of cancer pain mechanisms by using central modulation biomarkers (quantitative sensory testing and EEG indices) to characterize and profile the patients. The research proposal is: 1. To assess the central pain biomarkers of cancer pain: select the best ones to classify the patients who experience pain in relation to those who do not, and analyze the role of other moderator variables. 2. To create a database of pain modulation biomarkers in cancer pain. The study will use quantitative sensory evaluation equipment (thermal contact stimulator (TCS II) and cold plate) to measure the quantitative sensory testing biomarkers and a portable recording system of 32 electrodes adapted for clinical use to measure EEG indices. In addition, the team will conduct a face-to-face interview session, use different questionnaires (both on paper and via an online platform) and collect data from the patient's medical records to assess the different variables. The staff involved in the study are oncologists and neuroscience researchers. All staff have received specific training in data collection (quantitative sensory evaluation and EEG). The study will be carried out in hospitals, research institutes and universities. The study team will make a single assessment at a single point in time, which will consist of a face-to-face assessment (estimated duration 2h) and the completion of several questionnaires through an online platform, from home (estimated duration 1h).

Interventions

Inclusion criteria

Cancer patients with pain: 1. Adult subjects ≥ 18 years old 2. Able to provide informed consent to participate in the study 3. Able to self-report pain 4. To have a diagnosis of cancer affecting the lung, breast, pancreas, colon or prostate (with metastases or not) 5. The life expectancy of at least six months 6. Cancer pain persisting despite best-tolerated pharmacological treatment 7. Pain rated ≥5 on a 0-10 Numeric Rating Scales (NRS) persisting for over 1 month prior to enrolment 8. Ability to use the internet and WhatsApp or have a person (relative, caregiver) to help them Cancer patients with no pain: 1. Adult subjects ≥ 18 years old 2. Able to provide informed consent to participate in the study 3. Able to self-report pain 4. To have a diagnosis of cancer affecting the lung, breast, pancreas, colon or prostate (with metastases or not) 5. The life expectancy of at least six months 6. No chronic pain after cancer disease or treatment 7. Ability to use the internet and WhatsApp or have a person (relative, caregiver) to help them

Exclusion criteria

Current key exclusion criteria as of 27/02/2026: Cancer patients with pain: 1. Pregnant women or women of fertile age who did not have efficacious contraception during the whole period of the study 2. Neurological or psychiatric diseases (except anxiety or depression) 3. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease) 4. History of neurosurgery, traumatic brain injury with loss of consciousness, and/or cortical lesions 5. Present risk factors for receiving tES (e.g., history of epilepsy, metal devices in the brain, etc.) Cancer patients with no pain: 1. Pregnant women or women of fertile age who did not have efficacious contraception during the entire period of the study. 2. Neurological or psychiatric diseases (except anxiety or depression). 3. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease). 4. History of neurosurgery, traumatic brain injury with loss of consciousness, and/or cortical lesions. 5. History of non-malignant chronic pain. Previous key exclusion criteria: Cancer patients with pain: 1. Pregnant women or women of fertile age who did not have efficacious contraception during the whole period of the study 2. Neurological or psychiatric diseases (except anxiety or depression) 3. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease) 4. History of neurosurgery, traumatic brain injury with loss of consciousness, and/or cortical lesions 5. Present risk factors for receiving tES (e.g., history of epilepsy, metal devices in the brain, etc.) 6. History of non-malignant chronic pain Cancer patients with no pain: 1. Pregnant women or women of fertile age who did not have efficacious contraception during the entire period of the study. 2. Neurological or psychiatric diseases (except a

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