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

Not Applicable

• Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN); Nervous System Diseases

• Registration Number: ISRCTN13477304
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-15
• Last Update Posted: 5 February 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Development (or persistence) of painless or painful CIPN measured:<br>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. <br>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.<br>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.<br>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.