CIPN in Early Stage Breast Cancer Patients

NCT ID: NCT05441722

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2024-07-01

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, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exercise

Participants will be invited to perform a bout of supervised moderate-intensity aerobic exercise. Patients receiving chemotherapy with sequential anthracycline-docetaxel will be offered the exercise before each docetaxel-containing infusion, whilst patients receiving weekly paclitaxel will perform the exercise every three weeks during treatment. Each session will comprise of moderate-intensity aerobic exercise on a cycle ergometer. Participants will perform a 5 to 10-minute warm-up.

Participants will then complete a 30-minute bout at 13-14 RPE whilst. This corresponds to a qualitative description of "somewhat hard" and equates to approximately 60% age-predicted heart rate reserve. Heart rate will be monitored continuously with a Polar heart rate monitor and RPE will be collected every 5-minutes. The resistance on the bike will be reduced if heart rate reserve is > 65% or RPE is > 14 on the 6-20 Borg scale. Each session will finish with a 5 min cool-down at low-intensity (≤ 11 RPE).

Group Type: EXPERIMENTAL

Exercise prehabilitation

Intervention Type: BEHAVIORAL

Exercise on a cycle ergometer 24 hours before chemotherapy infusion.

Control

Participants allocated to this group will not receive a specific exercise intervention, but will be given a leaflet that provides general physical activity recommendations for cancer patients.

Recommendations will be based on published guidelines from the American College of Sports Medicine and American Cancer Society.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise prehabilitation

Exercise on a cycle ergometer 24 hours before chemotherapy infusion.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gateshead Health NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Northumbria Healthcare NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Temesi, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Queen Elizabeth Hospital

Gateshead, , United Kingdom

Countries

United Kingdom

Other Identifiers

262840

Identifier Type: -

Identifier Source: org_study_id