Study investigating the impact, risk and mechanisms of neuropathic pain (nerve pain) associated with chemotherapy. Partnership for Assessment and Investigation of Neuropathic Pain (PAINSTORM)

PAINSTORM: Partnership for Assessment and Investigation of NeuP: Studies Tracking Outcomes, Risks and Mechanisms

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13477304

Enrollment

150

Registered

2022-11-15

Start date

2022-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN) Nervous System Diseases

Interventions

The ultimate aim of the PAINSTORM consortium is to reach a new understanding of NeuP, by combining molecular, physiological and psychological approaches to describe its development and progression. An

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Planned course of potentially neurotoxic chemotherapy for the treatment of cancer. This includes the following: 2.1. Platinum drugs 2.2. Taxanes 2.3. Vinca alkaloids 2.4. Epothilones 2.5. Proteasome inhibitors 2.6. Thalidomide 2.7. Vedotin-based drugs 2.8. Checkpoint inhibitors

Exclusion criteria

Exclusion criteria: 1. Incapacity to give consent or to complete the study questionnaires due to insufficient language command or mental deficiencies, in the opinion of the investigator. 2. Functional impairment - ECOG Performance Status Scale great than or equal to 3 at baseline. 3. Concurrent clinically defined severe physical or psychiatric disorders that would preclude accurate phenotyping. 4. Moderate to severe pain from other causes that may confound assessment or reporting of pain if unable to differentiate from CIPN. 5. Patients who are in the opinion of the investigator, or treating oncology team, unsuitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
1. Development (or persistence) of painless or painful CIPN measured: 1.1. Using change in chemotherapy/dose reduction due to neurotoxicity measured using EORTC-CIPN20 questionnaire at baseline, mid and end of chemotherapy 3, 6, 9 and 12 months after completion of chemotherapy. 1.2. By pain location using a list of body sites / Body map measured at baseline, mid and end of chemotherapy 3, 6, 9 and 12 months after completion of chemotherapy. 1.3. Using development (or persistence) of painless or painful CIPN measured by Total Neuropathy Score clinical (TNSc) questionnaire at baseline, mid and end of chemotherapy. 2. Pain severity change in Chronic Pain Grade and Brief Pain Inventory (BPI) Numeric Rating Scale (average in last 24 hours) at baseline mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy.	—

Measure

Time frame

1. Development (or persistence) of painless or painful CIPN measured: 1.1. Using change in chemotherapy/dose reduction due to neurotoxicity measured using EORTC-CIPN20 questionnaire at baseline, mid and end of chemotherapy 3, 6, 9 and 12 months after completion of chemotherapy. 1.2. By pain location using a list of body sites / Body map measured at baseline, mid and end of chemotherapy 3, 6, 9 and 12 months after completion of chemotherapy. 1.3. Using development (or persistence) of painless or painful CIPN measured by Total Neuropathy Score clinical (TNSc) questionnaire at baseline, mid and end of chemotherapy. 2. Pain severity change in Chronic Pain Grade and Brief Pain Inventory (BPI) Numeric Rating Scale (average in last 24 hours) at baseline mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy.

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Secondary

Measure	Time frame
1. Lifestyle factors affecting CIPN measured using: 1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale, any changes to planned oncological treatment, Step count (ActivPALTM accelerometer), Patterns of daily living (time spent sitting, standing, stepping and lying) using ActivPALTM accelerometer measured at baseline, mid and end of chemotherapy 1.2. Past medical History/ co-morbidities, Family History, Details of cancer type and stage, Oncological treatment including planned chemo protocol (and any changes to this with reasons, Duration of CIPN, Smoking questionnaire, Alcohol questionnaire, Illicit drugs measured at baseline. 1.3. Physical function, measured using Saltin-Grimby Physical Activity Level Scale, and concomitant medication and at Baseline, mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy. 2. Demographic factors affecting CIPN: Age, Sex, Scottish Index of Multiple Deprivation (SIMD), Weight, Height, Years in full-time education, Working status, Household income measured at baseline 3. Clinical factors affecting CIPN: Blood/ serum biomarkers measured at baseline, mid and end of chemotherapy. 4. Type and quality of pain affecting CIPN measured using Douleur Neuropathique en 4 (DN4) and NeuP Symptom Inventory (12 items) at baseline, mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy. 5. Quality of lif affecting CIPN measured using EQ-5D-5L21, Brief Pain Inventory (BPI) Pain interference and Core MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy. 6. Psychological Health factors affecting CIPN measured using • Patient-Reported Outcomes Measurement Information System (PROMIS): Depression; Anxiety; Sleep; Support Trauma, Pain Catastrophizing Scale, Inventory of Depressive Symptomatology (IDS-SR), The 7-item State Optimism Measure (SOM-7) and Ten Item Personality Inv	—

Measure

Time frame

1. Lifestyle factors affecting CIPN measured using: 1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale, any changes to planned oncological treatment, Step count (ActivPALTM accelerometer), Patterns of daily living (time spent sitting, standing, stepping and lying) using ActivPALTM accelerometer measured at baseline, mid and end of chemotherapy 1.2. Past medical History/ co-morbidities, Family History, Details of cancer type and stage, Oncological treatment including planned chemo protocol (and any changes to this with reasons, Duration of CIPN, Smoking questionnaire, Alcohol questionnaire, Illicit drugs measured at baseline. 1.3. Physical function, measured using Saltin-Grimby Physical Activity Level Scale, and concomitant medication and at Baseline, mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy. 2. Demographic factors affecting CIPN: Age, Sex, Scottish Index of Multiple Deprivation (SIMD), Weight, Height, Years in full-time education, Working status, Household income measured at baseline 3. Clinical factors affecting CIPN: Blood/ serum biomarkers measured at baseline, mid and end of chemotherapy. 4. Type and quality of pain affecting CIPN measured using Douleur Neuropathique en 4 (DN4) and NeuP Symptom Inventory (12 items) at baseline, mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy. 5. Quality of lif affecting CIPN measured using EQ-5D-5L21, Brief Pain Inventory (BPI) Pain interference and Core MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, mid and end of chemotherapy at 3, 6, 9 and 12 months after completion of chemotherapy. 6. Psychological Health factors affecting CIPN measured using • Patient-Reported Outcomes Measurement Information System (PROMIS): Depression; Anxiety; Sleep; Support Trauma, Pain Catastrophizing Scale, Inventory of Depressive Symptomatology (IDS-SR), The 7-item State Optimism Measure (SOM-7) and Ten Item Personality Inv

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Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026