Feasibility of Neurophysiological Assessments and Exercise Prehabilitation in Breast Cancer Patients Receiving Taxane-based Chemotherapy: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Retention rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Retention rates
时间窗: Up to 18 months
The number of participants that continue to take part in the study throughout. The retention rates between those who did and did not receive their preferred allocation will then be compared.
Feasibility of measurement procedures
时间窗: 18 months
This will be assessed via the number of consented participants who complete baseline and follow-up testing.
Adverse events
时间窗: Up to 18 months
The number and type of adverse events experienced by participants will be noted to assess safety, along with exploring reasons for discontinuing exercise.
Recruitment Rates
时间窗: Through study recruitment, predicted time frame of 1 year.
This is assessed via the number of eligible patients who are invited and give informed consent to participate in the trial.
Reasons for dropout in discontinuing patients
时间窗: 18 months
Qualitative- when a participant no longer wants to take part, the reason for drop-out, if given, will be noted.
Attendance rates (to intervention)
时间窗: Up to 18 months
This will be assess by the percentage of exercise interventions that are attended bu participants in the intervention group.
The Physical Activity Enjoyment Scale (PACES)
时间窗: Up to 18 months
The Physical Activity Enjoyment Scale is an 18-item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7- point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items were negatively worded and seven items were positively worded. After reverse scoring the 11 negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment.
次要结局
- Body mass(Up to 18 months)
- Hip circumference(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)
- Peripheral Nerve Function(Up to 18 months)
- 9-Hole Peg Test(Up to 18 months)
- 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)
- Physician-reported CIPN(Up to 18 months)
- Waist circumference(Up to 18 months)
- Sway - swaymeter(Up to 18 months)
- Interviews of participants(Up to 18 months)
- Height(Up to 18 months)
- Short Physical Performance Battery (SPPB)(Up to 18 months)
- Tandem walk test(Up to 18 months)
- Touch perception (Semmes-Weinstein 10g Monofilament)(Up to 18 months)
- Maximal isometric grip strength(Up to 18 months)
- Vibration perception (128 Hz tuning fork)(Up to 18 months)
- Temperature perception (Tip Therm GmbH, Brueggen, Germany)(Up to 18 months)
- Habitual physical activity(Up to 18 months)
- Sway- accelerometer(Up to 18 months)