Status:
ACTIVE_NOT_RECRUITING
CIPN in Early Stage Breast Cancer Patients
Lead Sponsor:
Northumbria University
Collaborating Sponsors:
Gateshead Health NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Chemotherapy uses anti-cancer drugs to destroy cancer cells and is a common treatment for many cancers. Taxanes are the most widely used chemotherapy drugs given to breast cancer patients. However, ta...
Eligibility Criteria
Inclusion
- Histologically diagnosed stage IA-IIIC breast cancer.
- Scheduled to receive adjuvant or neoadjuvant chemotherapy with sequential anthracycline-docetaxel or weekly-paclitaxel.
- Willing and able to give written informed consent.
- Understand written and verbal instructions in English.
- American Society of Anaesthesiologists physical status I-III.
Exclusion
- Pre-existing diabetes mellitus.
- Pregnancy.
- Any sign/symptom of cardiovascular, metabolic or renal disease
- Diagnosed with metastatic breast cancer.
- Previous or existing symptoms of peripheral neuropathy.
- Absolute or relative contraindication to exercise testing and training as defined by the American College of Sports Medicine (ACSM) (38).
- Resting hypertension (≥ 180/100 mmHg) or tachycardia (≥ 100 bpm)
- Pre-existing cardiovascular, musculoskeletal, neurological or psychiatric condition that may affect their ability to complete the testing battery (as determined by the patient's treating Medical Oncologist).
- Internal electrical regulator (cardiac pacemaker or implantable cardioverter defibrillator).
- Previous exposure to taxanes at any time or exposure to other chemotherapy agents known to be associated with neuropathy (e.g., platinum therapy, bortezomib, vinblastine) within one year of starting in the study.
- Currently enrolled in clinical trials involving exercise or pharmacotherapy that could influence CIPN symptoms.
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05441722
Start Date
May 26 2022
End Date
July 1 2024
Last Update
May 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Queen Elizabeth Hospital
Gateshead, United Kingdom, NE9 6SX