Clinical trial NCT05441722: CIPN in Early Stage Breast Cancer Patients
Official title: Feasibility of Neurophysiological Assessments and Exercise Prehabilitation in Breast Cancer Patients Receiving Taxane-based Chemotherapy: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Gateshead Health NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Northumbria Healthcare NHS Foundation Trust
First posted: 2022-07-01
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Recruitment Rates
timeFrame: Through study recruitment, predicted time frame of 1 year.
measure: Reasons for dropout in discontinuing patients
timeFrame: 18 months
measure: Retention rates
timeFrame: Up to 18 months
measure: Feasibility of measurement procedures
timeFrame: 18 months
measure: Attendance rates (to intervention)
timeFrame: Up to 18 months
measure: The Physical Activity Enjoyment Scale (PACES)
timeFrame: Up to 18 months
measure: Adverse events
timeFrame: Up to 18 months
Secondary outcomes:
measure: European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20)
timeFrame: Up to 18 months
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
timeFrame: Up to 18 months
measure: Pain Quality Assessment Scale (PQAS).
timeFrame: Up to 18 months
measure: Godin Leisure-Time Exercise Questionnaire.
timeFrame: Up to 18 months
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: Up to 18 months
measure: Physician-reported CIPN
timeFrame: Up to 18 months
measure: Body mass
timeFrame: Up to 18 months
measure: Waist circumference
timeFrame: Up to 18 months
measure: Height
timeFrame: Up to 18 months
measure: Hip circumference
timeFrame: Up to 18 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: Up to 18 months
measure: Tandem walk test
timeFrame: Up to 18 months
measure: Maximal isometric grip strength
timeFrame: Up to 18 months
measure: Vibration perception (128 Hz tuning fork)
timeFrame: Up to 18 months
measure: Touch perception (Semmes-Weinstein 10g Monofilament)
timeFrame: Up to 18 months
measure: Temperature perception (Tip Therm GmbH, Brueggen, Germany)
timeFrame: Up to 18 months
measure: Peripheral Nerve Function
timeFrame: Up to 18 months
measure: Sway- accelerometer
timeFrame: Up to 18 months
measure: Sway - swaymeter
timeFrame: Up to 18 months
measure: Habitual physical activity
timeFrame: Up to 18 months
measure: Interviews of participants
timeFrame: Up to 18 months
measure: 9-Hole Peg Test
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Northumbria University
name: John Temesi, PhD
role: PRINCIPAL_INVESTIGATOR
References: