NCT05441722

CIPN in Early Stage Breast Cancer Patients

Feasibility of Neurophysiological Assessments and Exercise Prehabilitation in Breast Cancer Patients Receiving Taxane-based Chemotherapy: a Pilot Randomised Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Northumbria University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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, taxanes also have toxic side effects. One of the most severe side effects is damage to nerves in the peripheral nervous system; a neurological disorder known as peripheral neuropathy. Common symptoms of peripheral neuropathy are pain, numbness, and tingling in the hands and feet, which can lead to chemotherapy being prematurely discontinued. Unfortunately, treatment options to manage peripheral neuropathy are limited. Exercise has recently been proposed to reduce symptoms, but consistently exercising during chemotherapy is challenging for patients because of treatment-related side effects and fatigue. A more feasible approach may be to exercise on the day before each infusion. This research includes two linked studies that aim to evaluate whether measuring peripheral nerve function at various timepoints throughout chemotherapy and performing aerobic exercise 24 hours before each infusion is feasible and acceptable to patients. In study 1, the investigators will recruit early stage breast cancer patients, who are scheduled to receive taxanes, from medical oncology outpatient clinics. The investigators will ask consenting participants to make 4 or 5 separate visits to the Hospital at various timepoints throughout chemotherapy, depending on the type of chemotherapy they are prescribed. Each study visit will involve completing some questionnaires as well as tests of peripheral nerve function and functional ability. In phase 2, a new cohort of breast cancer patients undergoing the same chemotherapy regimens will be randomly allocated to an exercise group or a control group. The exercise group will be invited to perform a supervised bout of aerobic exercise (30 min of moderate-intensity on a cycle ergometer) one day before they receive chemotherapy. The findings will lay the foundations for future large-scale research.

Conditions

• Breast Cancer
• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
BEHAVIORAL	Exercise prehabilitation	Exercise on a cycle ergometer 24 hours before chemotherapy infusion.

Timeline

• Start date: 2022-05-26
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-07-01
• Last updated: 2024-05-08

Locations

1 site across 1 country: United Kingdom