MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC): a Pilot Study (TOXTAC)
Recruitment status was Recruiting
Many patients with breastcancer in the past, were treated with TAC. These last years, there is more and more focus on the effects of chemotherapy, particularly in children treated with this. One of these effects is damage to the heart muscle, which ultimately might affect the pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has not been previously investigated. The possibility exists that the adverse reactions in children are found in adults also could occur. Therefore we have initiated this trial.
|Study Design:||Observational Model: Cohort|
|Official Title:||MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC)|
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Given the lack of data on the incidence of subclinical cardiotoxicity after treatment with TAC we want to assess whether subclinical cardiovascular damage is present in adult patients with breast cancer who have completed treatment with (neo)adjuvant TAC one year previously, using MIBG (meta-iodobenzylguanidine) scintigraphy, novel echocardiographic techniques and blood biomarkers. Following the study by Lipshultz et al. we expect to find at least in 25% of the patients signs of subclinical cardiovascular damage with at least one of the three techniques.(11) If at least 10% is observed we will conclude that it is useful to further pursue the use of these techniques for the detection of subclinical cardiotoxicity in a next clinical study which will be powered to assess the predictive value of these techniques for the development of clinical heart failure. If a lower percentage is observed we will conclude that it is not useful to further pursue the use of these techniques for the detection of subclinical cardiotoxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246856
|Contact: H.W.M. van Laarhoven, Md||+31 24 361 03 firstname.lastname@example.org|
|Contact: L.F. de Geus-Oei, Md||+31 24 365 53 40||L.deGeus-Oei@nucmed.umcn.nl|
|University Medical Centre Nijmegen||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator: H.W.M. van Laarhoven, Md|
|Principal Investigator:||H.W.M. van Laarhoven, Md||University Medical Centre Nijmegen|