Chemotherapy Induced Cognitive Impairment

NCT05740787 | Recruiting

• 1 other identifier: 2-028-22
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy is toxic and challenges everyone differently. Most chemotherapy side-effects are known and well documented. However, the phenomenon of "chemo fog" also known as "chemobrain" has not been fully investigated and is often based on comments of breast cancer patients attending outpatient clinics during and after their chemotherapy. Changes in thinking ability like lack of concentration, loss of memory and the inability to hold a thought or even a conversation has a significant impact on the lives of breast cancer patients. Without understanding what "chemobrain" is, and what causes it, there is little that doctors can do to help at the moment. The team proposing this study believe that chemotherapy causes chemicals associated with inflammation to attack parts of the brain that are important for concentration and making new memories. Unfortunately, it is not possible to measure these chemicals directly in the brain, but we believe that a brain scan sensitive to excess iron, a marker of brain inflammation, can help. This project will measure thinking ability, such as memory and concentration, take a blood sample and do a brain scan before, during and after a patient has chemotherapy. We will then look for changes in iron in the brain areas that are important for concentration and memory and compare those to changes in thinking ability and to levels of inflammation chemicals in the blood. This information will be essential to help plan our next step which is to test ways to reduce the effects of "chemobrain".

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Cognitive performance late post chemotherapy

  General intelligence will be determined with PCA from 5 separate tests to give 'g' general intelligence. 'g' is scaled to have a mean of 100 and a standard deviation of 15 giving an IQ-like measure of general intelligence.

  6 months

Study Arms (1)

Patient

No intervention

Other: No intervention

Interventions

No intervention OTHER

Observation only

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Breast Cancer who have been prescribed adjuvant or neo-adjuvant chemotherapy

You may qualify if:

• Women and men \>18 years
• Diagnosed with HER2 negative breast cancer
• Receiving EC-Taxane or Taxane only based chemotherapy
• Able to communicate in English
• Willing and able to give informed consent for participation in the study.

You may not qualify if:

• Any patient whose physical condition will preclude them from lying still for the duration of the brain scan.
• pre-excisting mental condition/disability
• Contraindication to magnetic resonance scanning such as an implantable cardiac device.

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

NHS Grampian

Aberdeen, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Teresa Morris

CONTACT

+44 + 1224438363; t.morris@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 23, 2023
• Study Start: December 15, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)