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Aerobic exercise for Breast Cancer (CREATE Trial)

N/A

Waitlist Available

Led By Amy A Kirkham, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Female

willing and able to adhere to either intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment

Awards & highlights

CREATE Trial Summary

This trial is testing whether short-term exercise or diet can prevent damage to the heart, blood vessels, and skeletal muscles caused by chemotherapy agents called anthracyclines.

CREATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You are a woman.

Select...

You are willing and able to follow the study's instructions for either treatment option.

CREATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in left ventricular ejection fraction reserve (peak exercise - rest)

Secondary outcome measures

Change in LV mass

Change in LV volumes

Body Weight Changes

+12 more

Other outcome measures

Change in circulating markers of oxidative stress/antioxidants

Change in clinical tumor size

Combined clinical end-point

+1 more

CREATE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Aerobic exerciseExperimental Treatment1 Intervention

The exercise arm includes a single bout of supervised treadmill walking scheduled such that it would end approximately 24 hours prior to each of the participant's scheduled anthracycline treatment time.

Group II: 50% caloric restrictionExperimental Treatment1 Intervention

The caloric restriction arm will restrict their total caloric intake by 50% for 48 hours prior to each anthracycline treatment.

Group III: Usual careActive Control1 Intervention

The usual care arm will be asked to maintain their typical exercise and diet throughout treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

50% caloric restriction

2017

N/A

~60

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,720 Total Patients Enrolled

14 Trials studying Breast Cancer

2,283 Patients Enrolled for Breast Cancer

Susan G. Komen Breast Cancer FoundationOTHER

65 Previous Clinical Trials

217,130 Total Patients Enrolled

41 Trials studying Breast Cancer

215,072 Patients Enrolled for Breast Cancer

Amy A Kirkham, PhDPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

178 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are there in this experiment?

"Affirmative. The clinical trial posted on October 15th 2017 has been actively recruiting participants according to the data found on clinicaltrials.gov, and was recently updated on July 11th 2022. 56 individuals are needed at a single site for this experiment."

Answered by AI

Does this experiment have any openings for participants?

"Affirmative. The clinical trial, which was first listed on October 15th 2017 and last updated on July 11th 2022 is still recruiting participants via the website clinicaltrials.gov. 56 candidates are being accepted at a single medical site."

Answered by AI

Recent research and studies

BMC CancerJournal

Rationale and Design of the Caloric Restriction and Exercise Protection from Anthracycline Toxic Effects (CREATE) Study: A 3-arm Parallel Group Phase II Randomized Controlled Trial in Early Breast Cancer

Kirkham, Amy A., D. Ian Paterson, Carla M. Prado, John M. Mackey, Kerry S. Courneya, Edith Pituskin, and Richard B. Thompson. 2018. “Rationale and Design of the Caloric Restriction and Exercise Protection from Anthracycline Toxic Effects (CREATE) Study: A 3-arm Parallel Group Phase II Randomized Controlled Trial in Early Breast Cancer”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-018-4778-7.

clinicaltrials.govStudy

Caloric Restriction and Exercise for Protection From Anthracycline Toxic Effects

2017. "Caloric Restriction and Exercise for Protection From Anthracycline Toxic Effects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03131024.