Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. The main question it aims to answer is: What are the effects of a short-term diet with 30% caloric and 70% protein restriction (PCR) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer. Researchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin T (hsTnT) levels- will be different between these two groups.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant ATC-based chemotherapy and of intent to start anticancer treatment;

• age between 18 and 75 years;

• written informed consent;

• body mass index ≥ 19.

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Sheraz Ditta, PharmD
s.ditta@erasmusmc.nl
+31639462883
Backup
Franny Jongbloed, MD/PhD
f.jongbloed@erasmusmc.nl
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2026-05
Participants
Target number of participants: 32
Treatments
Other: Protein- and Calorie restriction group
This group will receive the dietary intervention.
No_intervention: Control Group
This group will not receive any intervention.
Related Therapeutic Areas
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov