Clinical trial NCT06622954: Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
Official title: Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiotoxicity
Breast Cancer
Keywords: Dietary restriction
Diet
Anthracyclines
High sensitivity troponin T
HsTnT
Oxidative stress
Breast cancer
Cardiotoxicity
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, 1 control group and 1 intervention group.
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: High-sensitivity troponin T (hsTnT)
timeFrame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.
Secondary outcomes:
measure: Left ventricular ejection fraction and global longitudinal (LVEF and GLS)
timeFrame: 6 months and 12 months after start of anthracycline therapy
measure: Creatine kinase
timeFrame: Bloodsamples will be taken before and 1 hour after each anthracycline cycle. The cycles are given once every 2 weeks, for 4 cycles in total.
measure: Effect of dietary intervention on tumor volume/response
timeFrame: After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks)
measure: Metabolic parameters
timeFrame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.
measure: Other anthracycline-related toxicities
timeFrame: After each anthracycline based chemotherapy cycle, which is given every 2 weeks. There will be 4 cycles in total.
measure: Effect of dietary intervention on pharmacokinetics of anthracycline
timeFrame: Bloodsamples will be taken before and 1 hours after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.
measure: Troponin levels
timeFrame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles.
measure: Brain natriuretic peptide (NT-proBNP)
timeFrame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.
measure: Subjective wellbeing
timeFrame: During each anthracycline chemotherapy cycle. The chemotherapy is given every 2 weeks, in total 4 cycles. Then 6 months and 12 months after start of anthracycline therapy questionnaires will be taken again.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: South-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Franny Jongbloed, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: