CIPN in Early Stage Breast Cancer Patients

NCT05441722 | Active Not Recruiting

• 1 other identifier: 262840
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Recruitment Rates

  This is assessed via the number of eligible patients who are invited and give informed consent to participate in the trial.

  Through study recruitment, predicted time frame of 1 year.

• Reasons for dropout in discontinuing patients

  Qualitative- when a participant no longer wants to take part, the reason for drop-out, if given, will be noted.

  18 months

• Retention rates

  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.

  Up to 18 months

• Feasibility of measurement procedures

  This will be assessed via the number of consented participants who complete baseline and follow-up testing.

  18 months

• Attendance rates (to intervention)

  This will be assess by the percentage of exercise interventions that are attended bu participants in the intervention group.

  Up to 18 months

• The Physical Activity Enjoyment Scale (PACES)

  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.

  Up to 18 months

• Adverse events

  The number and type of adverse events experienced by participants will be noted to assess safety, along with exploring reasons for discontinuing exercise.

  Up to 18 months

Secondary Outcomes (22)

• 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

Study Arms (2)

Exercise

EXPERIMENTAL

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).

Behavioral: Exercise prehabilitation

Control

NO INTERVENTION

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.

Interventions

Exercise prehabilitation BEHAVIORAL

Exercise on a cycle ergometer 24 hours before chemotherapy infusion.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead
• Gateshead Health NHS Foundation Trust: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• Northumbria Healthcare NHS Foundation Trust: collaborator

Study Sites (1)

Queen Elizabeth Hospital

Gateshead, NE9 6SX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John Temesi, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: July 1, 2022
• Study Start: May 26, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

GB (1)