Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Natural history/Epidemiology, Treatment	Active	18 and over	NCI	UCD-CCSO001 CCSO001, 200816282-1, NCT00859157

Objectives

Primary

1. To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer.

Secondary

1. To compare the total time of operation from incision to completion of wound closure.
2. To compare the time of operation from first incision to completion of skin flaps.
3. To compare the total estimated blood loss.
4. To compare the number of days the Jackson-Pratt drain is left in place under skin flaps with wound drainage > 30 mL/24 hours.
5. To compare the incidence of wound complications such as skin necrosis, hematoma, cellulitis, abscess, and seroma between groups.

Entry Criteria

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

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

Patient Characteristics:

• Menopausal status not specified
• WBC ≥ 1,500/mm³
• Platelet count ≥ 90,000/mm³
• 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

Expected Enrollment

Outcomes

Post-operative pain at 1 and at 7-10 days after mastectomy

Number of acetaminophen/oxycodone tablets taken
Total time of operation from breast incision to completion of wound closure
Time of operation from first incision to completion of both superior and inferior skin flaps
Estimated blood loss
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively

Outline

Patients are grouped according to which surgeon provided their evaluation and treatment recommendations.

• Group 1: Patients undergo standard mastectomy.



• Group 2: Patients undergo tumescent mastectomy.

All patients receive standardized post-operative pain management comprising morphine sulfate for analgesia or an equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a comparable amount of another narcotic/acetaminophen combination) every 6 hours as needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).

Trial Contact Information

Trial Lead Organizations

University of California Davis Cancer Center

Steve Martinez, MD, Principal investigator		Ph: 916-734-7265

U.S.A.
California
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089

Registry Information
Official Title		Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
Trial Start Date		2008-10-01
Trial Completion Date		2010-10-01 (estimated)
Registered in ClinicalTrials.gov		NCT00859157
Date Submitted to PDQ		2009-02-02
Information Last Verified		2009-03-06
NCI Grant/Contract Number		CA93373