Status:
COMPLETED
Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Pain
Eligibility:
FEMALE
18-120 years
Brief Summary
RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known whether tumescent mastectomy or standard mastectomy results in less pain in women with breast cancer. PURPO...
Detailed Description
OBJECTIVES: Primary * To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer. Secondary * To compare the total time of operation from incisio...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Invasive (ductal or lobular) breast cancer
- In situ (ductal) breast cancer
- Stage 0-III disease
- Localized disease
- Candidate for curative mastectomy and selected mastectomy or modified radical mastectomy for surgical option of treatment at the University of California Davis Medical Center
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- WBC ≥ 1,500/mm\^3
- Platelet count ≥ 90,000/mm\^3
- PT/PTT ≤ upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No NYHA cardiac disease class III-IV
- Cancer survivors must have undergone potentially curative therapy for all prior malignancies with no evidence of prior malignancy within the last 5 years, except for effectively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix treated by surgery alone, or lobular carcinoma in situ of the breast treated by surgery alone
- Body Mass Index ≤ 40
- PRIOR CONCURRENT THERAPY:
- No prior major breast surgery, including breast augmentation or reduction surgery
- No preoperative chemotherapy or radiotherapy
- No concurrent immediate breast reconstruction
- No concurrent bilateral mastectomy
- No concurrent narcotic pain medication
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00859157
Start Date
October 1 2008
End Date
January 1 2014
Last Update
June 21 2017
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817