NCT03131024: CREATE

Caloric Restriction and Exercise for Protection From Anthracycline Toxic Effects

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing 50% caloric restriction in Breast Cancer Female in 58 participants. Completed in 5 May 2021.

Timeline

15 October 2017

Primary endpoint
5 May 2021

5 May 2021

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	58
Start date	15 October 2017
Primary completion	5 May 2021
Estimated completion	5 May 2021
Sites	1 location across Canada

Drugs / interventions tested

• 50% caloric restriction
• Aerobic exercise — full drug profile →

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →

Sponsor

University of Alberta

Who can join

18 and older, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Doxorubicin and epirubicin are part of the class of chemotherapy agents called anthracyclines that are commonly used to treat breast cancer. Although these treatments work well against the tumor, they are known to cause damage to the heart muscle, resulting in diminished heart function that can be permanent, and may also damage the blood vessels and skeletal muscles. The purpose of this study is to determine whether short-term application of these interventions with specific timing relative to the receipt of each treatment can prevent the negative effects of anthracycline treatment on the heart, aorta (largest artery leaving the heart), and skeletal muscle, and reduce treatment symptoms. Fifty-six early stage breast cancer patients who will receive anthracycline treatment will be randomly assigned to 1 of 3 groups who will: 1) perform a single 30-minute aerobic exercise session 24 hours prior to each treatment; 2) eat a diet consisting of 50% less calories for 48 hours prior to each treatment; or 3) receive usual cancer care. Magnetic resonance imaging (MRI) will be used to precisely measure the function of the heart, aorta, and the lower leg skeletal muscle at rest, and again during exercise to allow detection of more subtle signs of damage. We will also measure exercise capacity (i.e. aerobic fitness), microscopic damage to the heart muscle cells, a marker released into the blood in response to anthracycline-related heart damage, tumor size in patients receiving chemotherapy before surgery, quality of life and fatigue. These measures will be performed before treatment, at the end of treatment and 1 year later.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
   Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x
2. Energy Restriction and Colorectal Cancer: A Call for Additional Research.
   Castejón M, Plaza A, Martinez-Romero J, Fernandez-Marcos PJ, et al · · 2020 · cited 41× · PMID 31906264 · DOI 10.3390/nu12010114
3. Preventive Cardio-Oncology: The Time Has Come.
   Brown SA. · · 2019 · cited 35× · PMID 31998754 · DOI 10.3389/fcvm.2019.00187
4. 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 AA, Paterson DI, Prado CM, Mackey JR, et al · · 2018 · cited 21× · PMID 30176834 · DOI 10.1186/s12885-018-4778-7
5. Advances in Diet and Physical Activity in Breast Cancer Prevention and Treatment.
   Khalifa A, Guijarro A, Nencioni A. · · 2024 · cited 17× · PMID 39064705 · DOI 10.3390/nu16142262
6. Targeting Mitochondria and Oxidative Stress in Cancer- and Chemotherapy-Induced Muscle Wasting.
   Huot JR, Baumfalk D, Resendiz A, Bonetto A, et al · · 2023 · cited 15× · PMID 36310444 · DOI 10.1089/ars.2022.0149
7. Modeling Precision Cardio-Oncology: Using Human-Induced Pluripotent Stem Cells for Risk Stratification and Prevention.
   Perry TR, Roberts ML, Sunkara B, Maddula R, et al · · 2021 · cited 6× · PMID 33937943 · DOI 10.1007/s11912-021-01066-2
8. Approaches to management of cardiovascular morbidity in adult cancer patients - cross-sectional survey among cardio-oncology experts.
   Hedayati E, Papakonstantinou A, Månsson-Broberg A, Bergh J, et al · · 2020 · cited 1× · PMID 32884837 · DOI 10.1186/s40959-020-00070-y