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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN35887998
Enrollment
750
Registered
2023-05-30
Start date
2024-02-20
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

University of Santiago de Compostela
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

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

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 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.

Design outcomes

Primary

MeasureTime frame
Cancer pain measured using a Numeric Rating Scale (NRS) at one timepoint

Secondary

MeasureTime frame
The study team aim to assess a number of variables to characterize patients with cancer pain, comparing patients with and without pain (cases versus controls). All variables are assessed at one time point (cross-sectional study): 1. Sociodemographic and clinical variables measured using an interview 2. Clinical variables measured using data from the clinical history of the patients 3. Mood (anxiety and depression), pain, sleep quality, fatigue, pain catastrophizing, cognitive functioning (subjective complaints) and quality of life, etc. measured using questionnaires 4. Quantitative Sensory Testing biomarkers measured using a thermal contact stimulator (TCS II) and a cold plate 5. Electroencephalogram (EEG) indices measured using a portable recording system of 32 electrodes adapted for clinical use

Countries

Germany, Israel, Romania, Spain, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026