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

NCT01246856 | Unknown

• 1 other identifier: UMCNONCO201005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Cardiotoxicity; Breast cancer treatment; MIBG scintigraphy; Strain Echocardiography; patients who have been treated with TAC one year previously

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who have been treated with TAC one year previously

You may qualify if:

• Female patients with breast cancer, ≥ 18 years old at the time of breast cancer diagnosis

You may not qualify if:

• Evidence of breast cancer recurrence or metastatic disease
• Evidence of heart disease at the time of breast cancer diagnosis
• Evidence of renal failure at the time of cardiac evaluation
• Pregnant or lactating
• Evidence of diabetes mellitus or Parkinson's disease
• Evidence of an MIBG-accumulating tumor (pheochromocytoma, paraganglioma, chemodectoma, ganglioneuroma, neuroblastoma, carcinoid, medullary thyroid cancer, neurofibromatosis, retinoblastoma, esthesioneuroma, schwannoma, merkelcel-tumor, pancreatic islet cell tumors, small cell lung carcinoma, melanoma

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Centre Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• H.W.M. van Laarhoven, Md

  University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

H.W.M. van Laarhoven, Md

CONTACT

+31 24 361 03 53; h.vanlaarhoven@onco.umcn.nl

L.F. de Geus-Oei, Md

CONTACT

+31 24 365 53 40; L.deGeus-Oei@nucmed.umcn.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

NL (1)