Dietary changes to reduce heart damage in breast cancer patients
Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.
This study is testing if a special diet that cuts calories and boosts protein can help protect the hearts of women with early-stage triple-negative breast cancer during chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06622954 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a short-term diet that restricts calories and increases protein intake on cardiotoxicity in women with early-stage breast cancer undergoing anthracycline chemotherapy. Participants will be divided into two groups: one receiving the dietary intervention and the other following a regular diet. The primary outcome will be measured by the levels of high-sensitivity troponin T (hsTnT) to assess heart damage. The study focuses on newly diagnosed triple-negative breast cancer patients aged 18 to 75.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with newly diagnosed triple-negative breast cancer who are about to start anthracycline-based chemotherapy.
Not a fit: Patients with a known history of cardiac dysfunction or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce heart damage in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While dietary interventions in cancer treatment are being explored, this specific approach to prevent cardiotoxicity is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Allergic to any of the ingredients of the diet; * Known history of cardiac dysfunction; * Severe morbidity with the inability to receive anticancer treatment. * Participation in another clinical trial with an intervention arm (database and/or biobank studies excluded); * Pregnant women * Previous treatment with anthracycline * Estrogen receptor positive status
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Franny Jongbloed, MD/PhD — Erasmus Medical Center
- Study coordinator: Sheraz Ditta, PharmD
- Email: s.ditta@erasmusmc.nl
- Phone: +31639462883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.