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

Sponsors

Lead Sponsor: Northumbria University

Collaborator: Gateshead Health NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust

Source Northumbria University
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.

Overall Status Recruiting
Start Date 2022-05-26
Completion Date 2024-01-01
Primary Completion Date 2024-01-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Recruitment Rates Through study recruitment, predicted time frame of 1 year.
Reasons for dropout in discontinuing patients 18 months
Retention rates Up to 18 months
Feasibility of measurement procedures 18 months
Attendance rates (to intervention) Up to 18 months
The Physical Activity Enjoyment Scale (PACES) Up to 18 months
Adverse events Up to 18 months
Secondary Outcome
Measure Time Frame
European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) Up to 18 months
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Up to 18 months
Pain Quality Assessment Scale (PQAS). Up to 18 months
Godin Leisure-Time Exercise Questionnaire. Up to 18 months
Functional Assessment of Cancer Therapy-Breast (FACT-B) Up to 18 months
Physician-reported CIPN Up to 18 months
Body mass Up to 18 months
Waist circumference Up to 18 months
Height Up to 18 months
Hip circumference Up to 18 months
Short Physical Performance Battery (SPPB) Up to 18 months
Tandem walk test Up to 18 months
Maximal isometric grip strength Up to 18 months
Vibration perception (128 Hz tuning fork) Up to 18 months
Touch perception (Semmes-Weinstein 10g Monofilament) Up to 18 months
Temperature perception (Tip Therm GmbH, Brueggen, Germany) Up to 18 months
Peripheral Nerve Function Up to 18 months
Sway- accelerometer Up to 18 months
Sway - swaymeter Up to 18 months
Habitual physical activity Up to 18 months
Interviews of participants Up to 18 months
Enrollment 48
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Exercise prehabilitation

Description: Exercise on a cycle ergometer 24 hours before chemotherapy infusion.

Arm Group Label: Exercise

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.

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
John Temesi, PhD Principal Investigator Northumbria University
Overall Contact

Last Name: John Temesi, PhD

Phone: +44 (0)191 227 3535

Email: [email protected]

Location
Facility: Status: Contact: Queen Elizabeth Hospital Lucy Blackwell 0191 445 2509 [email protected]
Location Countries

United Kingdom

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Exercise

Type: Experimental

Description: 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).

Label: Control

Type: No Intervention

Description: 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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Outcomes Assessor)

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