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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Lesley Colvin
+44 1382381880
l.a.colvin@dundee.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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

Recruiting

Open to: All Genders

Age: Adult

Dundee Bristol

Medical Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Nerve or ‘neuropathic’ pain can occur when the nerves are damaged in some way. Unfortunately, many of the commonly used and effective chemotherapies for cancer treatment can damage nerves. People may develop Chemotherapy Induced Peripheral Neuropathy (CIPN) with pain and numbness, particularly in the hands and feet, during or after treatment.
CIPN can be so severe that the dose of chemotherapy needs to be reduced, or even stopped, during treatment. There are no effective preventive treatments, and limited treatment options available if CIPN does develop. We do not understand why some people get neuropathic pain from chemotherapy whilst others do not, nor why it gets better in some people but
not in others. Research that we have done has found that sometimes factors such as a person’s lifestyle, other diseases they have, past experiences they’ve had and family history (genetics), can make someone more likely to develop neuropathic pain. We want to understand what things make someone more or less likely to develop CIPN, and how it changes over time. This will then help us develop ways to reduce the risk of developing CIPN, as well as hopefully preventing or treating it.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Dec 2022 30 Jun 2025

If you decide to take part in the study, you will be asked to attend study visits before starting chemotherapy, half-way through your chemotherapy and at the end of your chemotherapy.

At the first study visit, you will be asked to complete a consent form to confirm that you want to take part in the study. You will also be asked about your health and any medication you take. The following will also be recorded:
• Height and weight.
• Quantitative Sensory Testing (QST) – to examine nerve function. This includes checking how you feel different sensations such as temperature changes, light touch, and pin prick.
• Questionnaires – will be completed covering aspects of health, pain and quality of life. You will also be asked to complete questionnaires at home in between study visits, before each cycle of chemotherapy. Completed questionnaires can be sent in by email or completed online or sent by post.
The following activities are optional:
• Blood test
• Activity monitor – an activity monitor should be worn for 7 days to record steps per day and time spent sitting, standing and lying down.
• Brain MRI scan –100 participants will have a Magnetic Resonance Imaging (MRI) scan of their brain. The MRI will record any changes in nerves before and after chemotherapy.

Second and third visits
Activities:
• Quantitative Sensory Testing (QST) – as described for the first visit above
• Questionnaires
• Blood sample
• Activity monitor
• Brain MRI – on the third visit only.

After participants have finished their chemotherapy, they will be contacted again 3, 6, 9 and 12 months later to check their health and medication and complete a questionnaire. This follow-up contact will be by phone, online and/or by post.


Patients 18 years or older with a planned course of potentially neurotoxic chemotherapy for the treatment of cancer.

You can take part if:



You may not be able to take part if:


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.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Ninewells Hospital and Medical School
    NHS Tayside
    Dundee
    DD1 9SY
  • University Hospitals Bristol NHS Foundation Trust
    Clinical Trials Unit Bristol Haematology & Oncology Centre Horfield Road
    Bristol
    BS2 8ED

Benefits:
The study might not bring benefit to participants personally, but the aim is to improve the treatment of people getting chemotherapy and to help to develop new ways to prevent or treat CIPN. Participants will be monitored closely for CIPN throughout their chemotherapy, with regular detailed assessments by an experienced research team. As participants are being monitored closely for CIPN, if they develop CIPN it might be picked it up more quickly than usual.
Risks:
It may be tiring for participants to have regular assessments throughout their chemotherapy.
Quantitative Sensory Testing (QST) involves checking how well participants can feel skin temperature, touch and pressure changes. These tests may cause mild discomfort to the skin or be slightly painful.
Wearing an activity monitor can sometimes cause mild skin irritation.

Prof Lesley Colvin
+44 1382381880
l.a.colvin@dundee.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Dundee and funded by UK Research and Innovation; Versus Arthritis; Eli Lilly and Company.



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What will you do next?
Read full details for Trial ID: ISRCTN13477304

Or CPMS 53404

Last updated 17 January 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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