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Trial Title:
Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer
NCT ID:
NCT05803889
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Cardiac evaluation
Description:
In order to obtain information on the body composition of the patients, a body
composition measurement will be performed. A resting cardiac echocardiography will be
performed to record myocardial deformations in a non-vulnerable way. A non-invasive
evaluation of arterial function will be performed by ultrasound on the femoral artery
during a standardized passive movement of the leg. An assessment of myocardial
deformations will also be performed under submaximal exercise conditions (at a target
heart rate of 120 beats per minute, low to moderate exercise intensity). All of these
measurements will be performed during evaluation 1 and reproduced in the same way during
the 4 other sessions planned during (evaluation 2, 3 and 4) and after the treatment
(evaluation 5).
Arm group label:
EC + Tax group
Intervention type:
Other
Intervention name:
Cardiac evaluation
Description:
The same measurements as the EC + Tax group will be performed but only once, at the end
of the treatment.
Arm group label:
Trastuzumab group
Summary:
The combination of epirubicin-cyclophosphamide (EC) and paclitaxel (Tax) is one of the
main chemotherapy treatments used in breast cancer patients. These treatments, which can
be combined with anti-HER2 therapy using trastuzumab, are frequently associated with side
effects including cardiac toxicity. However, this cardiac toxicity has only been
demonstrated several months after treatment and using global indices such as ejection
fraction.
The assessment of myocardial dysfunction using regional deformations and the kinetic of
this dysfunction during chemotherapy treatment has never been performed. In order to
counteract these myocardial dysfunctions, it is essential to better describe the kinetic
of the cardiac toxicity by initiating measurements since the beginning of the treatment,
in order to be able to propose adapted countermeasures (e.g. exercise training) in
parallel with the chemotherapy.
Criteria for eligibility:
Study pop:
Population composed of a group of breast cancer patients undergoing chemotherapy with EC
and Tax, and a group of breath cancer patients undergoing Trastuzumab treatment.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
Epirubicin-cyclophosphamide + paclitaxel group:
- Female ≥ 18 years
- Stage I to III breast cancer
- Patient being planned for (neo)adjuvant therapy combining EC and Taxol on a weekly
basis
- Enrolled in a social security plan
- Able to speak, read and understand French
Trastuzumab group:
- Female ≥ 18 years of age
- Stage I to III breast cancer
- Patient treated with trastuzumab
- Enrolled in a social security plan
- Able to speak, read and understand French
Exclusion Criteria:
For both groups: Epirubicin-cyclophosphamid + paclitaxel group and trastuzumab group
- Implantation of a pacemaker
- Contraindications to exercise
- Protected adult
- Psychiatric, musculoskeletal or neurological problems
- Pregnant or breastfeeding woman
- Uncontrolled high blood pressure
- Body Mass Index > 35 kg/m²
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de cancérologie Strasbourg Europe
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Valerie SARTORI
Phone:
368767223
Phone ext:
33
Email:
v.sartori@icans.eu
Contact backup:
Last name:
Manon VOEGELIN
Phone:
368767360
Phone ext:
33
Email:
m.voegelin@icans.eu
Investigator:
Last name:
Roland SCHOTT
Email:
Principal Investigator
Start date:
September 21, 2023
Completion date:
January 1, 2024
Lead sponsor:
Agency:
Institut de cancérologie Strasbourg Europe
Agency class:
Other
Collaborator:
Agency:
UR 3072
Agency class:
Other
Source:
Institut de cancérologie Strasbourg Europe
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05803889
