EXercise Influence on Taxane Side Effects (EXIT) Study

NCT02473861 | Completed

• 1 other identifier: H15-00888
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized control cross over trial of exercise training during or after taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise training for 8-12 weeks. The immediate exercise group will exercise during taxane chemotherapy and the delayed group will start exercise 2 weeks after completion of treatment. This design will allow for an assessment of the effects of exercise vs usual care during treatment, plus a comparison of the training response during vs. after chemotherapy.

Conditions

Breast Neoplasms

Keywords

exercise training; breast cancer; taxane chemotherapy; peripheral neuropathy; fatigue; autonomic function

Outcome Measures

Primary Outcomes (1)

• Change with treatment and maintenance post treatment in patient-reported taxane-related symptoms via the EORTC CIPN subscale

  European Organization for Research and Treatment of Cancer CIPN subscale

  14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy

Secondary Outcomes (4)

• Change with treatment and maintenance post treatment of heart rate variability

  14-0 days pre taxane chemotherapy, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion taxane chemotherapy

• Change with treatment and maintenance post treatment of blood pressure variability

  14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy

• Number of participants requiring medical management of taxane side effects

  Will be extracted from medical records 0-6 months after completion of chemotherapy

• Number of participants with clinical reporting of adverse events during taxane-chemotherapy treatment

  Will be extracted from medical records 0-6 months after completion of chemotherapy

Other Outcomes (5)

• Change with treatment and maintenance post treatment of aerobic fitness via estimated peak oxygen consumption

  14-0 days pre taxane chemotherapy, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy

• Change with treatment and maintenance post treatment of lower body muscular strength via estimated 1-repetition maximum leg press

  14-0 days pre taxane chemotherapy, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy

• Change with treatment and maintenance post treatment of upper body muscular strength via handgrip strength

  14-0 days pre taxane chemotherapy, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy

Study Arms (2)

Immediate exercise arm

EXPERIMENTAL

The length of the intervention for the immediate exercise group will be determined by treatment protocol and could range from 8 to 13 weeks. The intervention can begin up to one week before the first treatment and will continue until 2 weeks after the final taxane-containing treatment. The intervention will consist of thrice weekly supervised aerobic and resistance exercise training.

Other: Exercise

delayed exercise arm

EXPERIMENTAL

The delayed exercise group will begin an exercise intervention two weeks after completion of their last taxane-containing chemotherapy treatment that will last the length of their taxane chemotherapy plus two weeks. If participants in the delayed exercise group have a surgery planned during the intervention time that will require \>1 week off from exercise, the exercise intervention will be delayed until after the surgery. The intervention will consist of thrice weekly supervised aerobic and resistance exercise training.

Other: Exercise

Interventions

Exercise OTHER

Moderate intensity aerobic and resistance training. Five minutes each of warm-up, cool-down, balance and flexibility will also be performed.

Immediate exercise arm; delayed exercise arm

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Born female
• Age 19 or older
• Histologically confirmed stage I-IIIA breast cancer diagnosis
• Scheduled to receive neoadjuvant or adjuvant taxane-containing chemotherapy
• Willing and able to attend baseline assessment prior to first taxane-containing treatment
• Have reliable transportation to attend our exercise gym located near the Vancouver BCCA three times weekly for 8-13 weeks
• Be able to read and communicate in English
• Treating medical oncologist approval to participate

You may not qualify if:

• Receipt of further chemotherapy treatments after taxane-containing treatments
• Stage IV cancer
• Acute or uncontrolled health conditions including heart disease, respiratory disease (COPD or severe asthma)
• Diagnosis of diabetes at any time
• Personal history of neurological disorder
• Mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (includes orthopedic injury or arthritis that result in inability to exercise)
• Body mass index ≥40 kg/m2
• Previously received chemotherapy or thoracic radiation treatment

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Breast Cancer Training Center, 614 W. 8th Ave

Vancouver, British Columbia, V5Z 1C8, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kristin L Campbell, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 17, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

CA (1)