Status:
WITHDRAWN
Determining Quality of Life in Breast Cancer Patient After Completing Radiation,Chemotherapy,Surgery or Combination
Lead Sponsor:
American Scitech International
Conditions:
Breast Carcinoma
Eligibility:
FEMALE
25-85 years
Phase:
PHASE2
Brief Summary
Rationale: Determining quality of life in breast cancer patient after completing chemotherapy or radiation therapy or surgical procedures or any combination therapy. Intervention includes supportive ...
Detailed Description
OBJECTIVES: * Determine the quality of life in breast cancer patient after completing chemotherapy or radiation therapy or surgical procedures or any combination therapy in both Arms. * Determine the...
Eligibility Criteria
Inclusion
- Breast cancer patients
- 25 to 85 years old
- DISEASE CHARACTERISTICS:
- Received prior definitive treatment for stage I-IV breast cancer with or without adjuvant chemotherapy or radiation therapy or surgical therapy or any combination therapy.
- 3 to 18 months since completion therapy.
- PATIENT CHARACTERISTICS:
- Age:
- 25 to 49 vs 50 to 85
- Sex:
- Female
- Menopausal status:
- Not specified
- Performance status:
- Not specified
- Life expectancy:
- Not specified
- Hematopoietic:
- CBC in normal range:
- Hemoglobin - 10 g/dl
- Blood Glucose is twofold above the normal range
- Hepatic:
- Hepatic profile is twofold above the normal range:
- AST/ALT
- Bilirubin,total
- Protein (Albumin, Globulin)
- Renal:
- Renal tests are twofold above the normal range:
- Creatinine clearance 24 hours
- BUN
- Creatinine level
- Other:
- No current psychiatric diagnosis
- Mini Mental Status Examination
- No signs and symptoms MDD
- Anxiety disorder
- Post Traumatic Syndrome Disorder
- Status of Therapy:
- Chemotherapy:
- Completed
- Endocrine therapy:
- Completed
- Radiotherapy:
- Completed
- Surgery:
- Completed at least three months before the start of the study
Exclusion
- Age below 25 and above 85
- Subject with breast carcinoma in therapy
- Any current mental illness
- Hepatic enzymes are more than twofold from the normal range
- Renal impairment is more than twofold from the normal range
- Hemoglobin is less than 10 g/dl
- CBC results are below normal range
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00712621
Start Date
February 1 2010
End Date
February 1 2014
Last Update
November 24 2009
Active Locations (1)
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1
Practicing physician in New Jersey
Englishtown, New Jersey, United States, 07726