To investigate the effects of a 5-day diet with 30% caloric and 70% protein restriction on cardiotoxicity induced by anthracycline treatment in women with triple negative or hormone receptor-positive breast cancer. The biomarker high-sensitivity…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is to investigate the effectiveness of a diet with
30% caloric and 70% protein restriction on cardiotoxicity due to treatment with
anthracyclines. The primary study variable is cardiotoxicity, as measured by
high-sensitivity troponin T (hsTnT) concentrations.
Secondary outcome
Secondary outcome measures are:
- Difference in troponin levels, before and after each chemotherapy cycle, Δ
HsTnT.
- Brain natriuretic peptide, creatine kinase, electrocardiograms and
ultrasounds of the left ventricular ejection fraction (LVEF) and global
longitudinal strain.
- Other anthracycline-related toxicity, which will be measured by CTCAE-grading.
- Pharmacokinetics of anthracycline chemotherapy, following dietary
restriction. This is measured as concentrations of anthracyclines and the
active metabolites.
- Well-being of patients after dietary restriction and chemotherapy, to be
measured by means of questionnaires.
- Metabolic parameters to assess dietary adherence: retinol binding protein,
albumin, insulin and lipid profile.
- Effects of dietary restriction on tumor progression and tumor size by
radiographic response before, during and after treatment. This is presented as
Complete Response / Partial Response / Stable Disease / Progression of disease,
using the RECIST method. This response is also used as standard of care and has
therefore already been validated.
Background summary
Breast cancer is the leading cancer in women around the world. A cornerstone in
the treatment of breast cancer are anthracyclines. This is a group of medicines
that are given for, among other things, breast cancer. Anthracyclines are very
effective, but the biggest limiting factor for optimal use of this treatment is
cardiotoxicity. Cardiotoxicity can cause cardiac arrhythmias or even lead to
heart failure. This side effect can occur in any patient and is therefore the
reason why anthracyclines cannot be dosed optimally. In practice, the dose is
cumulative: for each patient, meaning there is a maximum amount of
anthracyclines that they may receive throughout their life.
In previous studies, we have shown that dietary restriction improved resistance
to oxidative stress. This was reflected in better recovery of patients after
kidney donation and kidney transplantation. In patients treated with the
chemotherapy drug irinotecan, dietary restriction increased active
concentrations of the drug without change in toxicity or side effects. In this
study we want to show whether a short-term calorie-restricted and low-protein
diet has the same positive effect as chemotherapy with anthracyclines. This
diet will be followed in patients diagnosed with early invasive breast cancer
prior to each chemotherapy regimen. The effects of this are compared with a
group that receives the same chemotherapy regimen without a diet.
Study objective
To investigate the effects of a 5-day diet with 30% caloric and 70% protein
restriction on cardiotoxicity induced by anthracycline treatment in women with
triple negative or hormone receptor-positive breast cancer. The biomarker
high-sensitivity troponin T (hsTnT) will primarily be used to measure
cardiotoxicity. Secondary, changes at the ultrasound level are also examined.
Furthermore, the effects of this diet on other anthracycline-related toxicity
and the effect on tumor progression will be investigated. Patient well-being
will be tracked through questionnaires.
Study design
A randomized controlled trial, in which the patients are divided into two
groups. Both groups will receive the same chemotherapy regimen. Group 1 follows
a diet with approximately 30% calorie and 70% protein restriction for 5 days
prior to each chemo cycle. To make the diet as homogeneous as possible,
synthetic nutrition will be given, based on the individual daily calorie
requirement. The outcome measures are compared with a control group to
investigate whether such a diet influences the cardiotoxicity of
anthracyclines. The control group will be called by an experienced dietician
before each anthracycline chemotherapy. They will be asked about all the food
eaten in the last 24 hours, which will be analyzed by the dietician.
Blood will be taken from patients for analysis and an electrocardiogram and
ultrasound will be performed a number of times. In addition, patients will be
asked to complete questionnaires regarding quality of life, pain, fatigue and
nausea.
Intervention
After consent has been given by the patients, they will be divided into 2
groups:
1) The intervention group. This group follows a prescribed diet 5 days prior to
each chemotherapy cycle, for a maximum of 4 cycles. This diet consists of 30%
caloric and 70% protein restriction, based on the individual daily energy
requirement.
2) The control group. He is not prescribed a diet, but is called by a dietitian
just before each anthracycline chemotherapy to ask what has been eaten in the
past 24 hours. Based on this, the calorie and macronutrient intake is
calculated.
Study burden and risks
For this study, 7 additional blood draws are taken during the routine blood
draws. Patients will have to complete standardized questionnaires before,
during and after each diet cycle to measure side effects and quality of life,
these will take approximately a few minutes each. In addition, an
electrocardiogram and ultrasound will be performed. The electrocardiogram will
be performed before each cycle, the ultrasound will be performed a total of 3
times during the study period (up to 12 months after the end of the study at
the latest).
The synthetic diet can cause a feeling of hunger, mild headache and slight
weight loss.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Women with newly diagnosed triple negative or hormone receptor-positive
breast cancer with an indication for (neo-)adjuvant anthracycline-based
chemotherapy and of intent to start anticancer treatment
2. Age between 18 and 75 years
3. Written informed consent
4. Body mass index >= 19.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Allergic to any of the ingredients of the diet
2. Known history of cardiac dysfunction
3. Severe morbidity with the inability to receive anticancer treatment.
4. Participation in another clinical trial with an intervention arm (database
and/or biobank studies excluded)
5. Pregnant women
6. Previous treatment with anthracycline
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83401.078.22 |