What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly chemotherapy, can cause a range of side effects including cardiac dysfunction (doxorubicin), peripheral neuropathy (paclitaxel and oxaliplatin), and premature menopause and increased risk of subsequent malignancies (cyclophosphamide). Other general side effects include fatigue, cognitive limitations, depression, anxiety, sleep problems, and pain, all of which can significantly impact the quality of life and physical functioning of patients.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer have traditionally focused on chemotherapy, hormone therapy, targeted therapy, and immunotherapy. However, treatments that align with the holistic goals of improving physical activity, functional mobility, muscle strength, quality of life, and health status include programs that incorporate exercise and lifestyle modifications. While specific drugs may not directly address these holistic outcomes, interventions such as structured exercise programs and self-management education have been shown to significantly benefit breast cancer survivors by enhancing their overall well-being and physical function.

What other types of research exist?

Promising novel alternatives for breast cancer patients include: 1) Technology-based interventions that support physical activity through self-regulation and goal setting, which have shown efficacy in maintaining physical activity levels post-intervention. 2) Telephone counseling interventions for aerobic exercise, which have demonstrated high adherence and improvements in quality of life and fatigue. 3) Rehabilitation programs combining physical exercise with heart rate variability biofeedback, which have shown significant improvements in physical capacity, muscle strength, and flexibility. These alternatives offer innovative approaches to enhance physical and emotional well-being in breast cancer patients.

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Exercise Program for Breast Cancer (NEXT-BRCA Trial)

N/A

Waitlist Available

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at intervention completion (approximately 1.3 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new program combining exercise sessions and educational classes for women with stage 1-3 breast cancer undergoing chemotherapy. The goal is to help these women manage the physical and emotional side effects of their treatment. Exercise can boost strength and mobility, while education offers strategies for coping with treatment challenges.

Who is the study for?

This trial is for English-speaking women over 18 with Stage 1-3 breast cancer who are currently undergoing chemotherapy. They must be cleared by their oncologist to do moderate exercise and live in the community without chronic conditions, cognitive impairments, or injuries that would limit exercise.

What is being tested?

The study tests a new program combining exercise and education against just education or usual care during chemotherapy. Women will be grouped to compare how these approaches affect their activity levels, strength, mobility, quality of life, health status, and healthcare use.

What are the potential side effects?

Since this trial involves moderate intensity aerobic exercises tailored for individuals undergoing chemotherapy for breast cancer, potential side effects may include typical post-exercise symptoms like muscle soreness or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at intervention completion (approximately 1.3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at intervention completion (approximately 1.3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at intervention completion (approximately 1.3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in baseline physical activity level

Secondary study objectives

Change in baseline aerobic capacity

Change in baseline levels of lower extremity strength

Change in baseline levels of resting BP

+5 more

Other study objectives

Adherence rate to intervention

Drop out rate throughout study

Recruitment rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Institution-Based Self-management only (SM)Experimental Treatment2 Interventions

Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.

Group II: Institution-Based Exercise and Self-Management (EXSM)Experimental Treatment3 Interventions

Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.

Group III: Usual careActive Control1 Intervention

Participants in this group will receive care as normally provided by their treating oncologist. This can be heterogeneous between different physicians and centres, but usually includes oncologists encouraging their patients to 'stay active'

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Booster Sessions

2008

Completed Phase 3

~1090

Exercise

2016

Completed Phase 1

~820

Self-Management

2008

N/A

~140

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include chemotherapy, which targets and kills rapidly dividing cancer cells; hormone therapy, which blocks hormones like estrogen that can promote cancer growth; and targeted therapy, which focuses on specific molecular targets within cancer cells. These treatments can cause significant side effects, including fatigue, muscle weakness, and reduced quality of life. Exercise and self-management education programs are essential as they help breast cancer patients manage these side effects, improve physical activity levels, enhance functional mobility, and boost overall health status and quality of life.

The effect of exercise on fatigue and physical functioning in breast cancer patients during and after treatment and at 6 months follow-up: A meta-analysis.Motor performance in children and adolescents with cancer at the end of acute treatment phase.