Clinical trial · Interventional
Caloric Restriction and Exercise for Protection From Anthracycline Toxic Effects
The Effects of Short-term Exercise or Caloric Restriction on Anthracycline Chemotherapy-related Treatment Toxicity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 50% caloric restriction | Dietary Supplement | — | UNRESOLVED |
| Aerobic exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Aerobic exercise
- description
- 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.
- interventionNames
- Other: Aerobic exercise
- type
- EXPERIMENTAL
- label
- 50% caloric restriction
- description
- The caloric restriction arm will restrict their total caloric intake by 50% for 48 hours prior to each anthracycline treatment.
- interventionNames
- Dietary Supplement: 50% caloric restriction
- type
- NO_INTERVENTION
- label
- Usual care
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age 18+ * Female * stage I-IIIC breast cancer * scheduled to receive an anthracycline-containing chemotherapy protocol * able to read and communicate in English * willing and able to adhere to either intervention Exclusion Criteria: * contraindications to MRI (e.g. pacemakers, metal implants) * contraindications to maximal exercise testing * pregnant * have orthopedic limitations to sustained exercise on all potential modes (treadmill, elliptical, bike) * have a body mass index \<19 kg/m2 * history of eating disorder (self- or oncologist-reported) * diabetes * severe food allergies or restrictions
References
Publications (1)
- DERIVEDKirkham AA, Paterson DI, Prado CM, Mackey JR, Courneya KS, Pituskin E, Thompson RB. 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. 2018 Sep 3;18(1):864. doi: 10.1186/s12885-018-4778-7. PMID 30176834