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Determination of central pain modulation biomarkers to characterize and profile cancer patients with refractory pain and adaptation and validation of a home-based transcranial brain stimulation procedure for their palliative care

Determination of central pain modulation biomarkers to characterize and profile cancer patients with refractory pain and adaptation and validation of a home-based transcranial brain stimulation procedure for their palliative care - PAINLESS-TreatCANCERPAIN

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031070
Enrollment
450
Registered
2023-01-31
Start date
2024-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C00-C97

Interventions

Group 1: Transcranial electrical stimulation of the mortor cortex of cancer patients with pain. Group 2: Transcranial electrical stimulation of the dorsolateral prefrontal cortex of cancer patients wi

Sponsors

Universitätsmedizin Göttingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Adult subjects = 18 years old. -Able to provide informed consent to participate in the study. -Able to self-report pain. -To have a diagnosis of cancer affecting lung, breast, pancreas or colon (with metastases or not). -The life expectancy of at least six months. -Cancer pain persisting despite best tolerated pharmacological treatment -Pain rated >= 5 on a 0-10 Numeric Rating Scale (NRS) persisting for over 1 month prior to enrolment. -Ability to use internet and WhatsApp or have a person (relative, caregiver) to help them.

Exclusion criteria

Exclusion criteria: -Pregnant women or women of fertile age that did not have efficacious contraception during the whole period of the study. -Neurological or psychiatric diseases (except anxiety or depression) -Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease). -History of neurosurgery, traumatic brain injury with loss of consciousness, and/or cortical lesions -Present risk factors for receiving tES (e.g., history of epilepsy, metal devices in the brain, etc.). -History of non-malignant chronic pain.

Design outcomes

Primary

MeasureTime frame
Numeric rating scale of the intensity of pain

Secondary

MeasureTime frame
-Use of analgesic medication (type and dose) -NRS of unpleasantness of pain -NRS of interference due to pain -NRS of fatigue

Countries

Germany, Israel, Romania, Spain, Switzerland

Contacts

Public ContactAndrea Antal

Universitätsmedizin Göttingen

aantal@gwdg.de+49 551 398461

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026