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Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00902668
First received: May 14, 2009
Last updated: June 11, 2013
Last verified: May 2013
Results First Received: April 11, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Radiation Toxicity
Interventions: Drug: lovastatin
Other: questionnaire administration
Procedure: adjuvant therapy
Radiation: accelerated partial breast irradiation
Radiation: external beam radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was open to accrual from 4/21/09 to 3/2/10. Patients were recruited from radiation oncology clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients can be registered only after pretreatment evaluation is completed and eligibility criteria are met. Protocol treatment begins on the first day of external beam radiation therapy or on the first day of brachytherapy and continues for 12 months.

Reporting Groups
  Description
Supportive Care (Lovastatin) Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Supportive Care (Lovastatin)  
STARTED     3  
COMPLETED     0  
NOT COMPLETED     3  
Protocol stopped due to slow accrual.                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Supportive Care (Lovastatin) Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Supportive Care (Lovastatin)  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 2  
Gender  
[units: participants]
 
Female     3  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy   [ Time Frame: during the first 5 years after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to no subjects analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Laurie W. Cuttino, MD
Organization: Virginia Commonwealth University
phone: 804-828-7232
e-mail: LCuttino@mcvh-vcu.edu


No publications provided


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00902668     History of Changes
Other Study ID Numbers: MCC-12044, HM12044, CDR0000642246, NCI-2012-01188
Study First Received: May 14, 2009
Results First Received: April 11, 2013
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board