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

Sponsor:	University of California, Davis
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00859157

Purpose

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.

PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.

Condition	Intervention
Breast Cancer Pain Perioperative/Postoperative Complications	Procedure: therapeutic conventional surgery

Study Type:	Observational
Official Title:	Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Post-operative pain at 1 and at 7-10 days after mastectomy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of acetaminophen/oxycodone tablets taken [ Designated as safety issue: No ]
Total time of operation from breast incision to completion of wound closure [ Designated as safety issue: No ]
Time of operation from first incision to completion of both superior and inferior skin flaps [ Designated as safety issue: No ]
Estimated blood loss [ Designated as safety issue: No ]
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours [ Designated as safety issue: No ]
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively [ Designated as safety issue: No ]

Estimated Enrollment:	74
Study Start Date:	October 2008
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 Patients undergo standard mastectomy.	Procedure: therapeutic conventional surgery Patients undergo tumescent or standard mastectomy
Group 2 Patients undergo tumescent mastectomy.	Procedure: therapeutic conventional surgery Patients undergo tumescent or standard mastectomy

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

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859157

Locations

United States, California
University of California Davis Cancer Center	Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089

Sponsors and Collaborators

University of California, Davis

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Steve R. Martinez, MD

University of California, Davis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of California Davis Cancer Center ( Steve R. Martinez )
Study ID Numbers:	CDR0000633754, UCD-CCSO001, 200816282-1
Study First Received:	March 7, 2009
Last Updated:	December 3, 2009
ClinicalTrials.gov Identifier:	NCT00859157 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

perioperative/postoperative complications
pain
ductal breast carcinoma in situ
invasive ductal breast carcinoma
invasive lobular breast carcinoma

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases

Postoperative Complications
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010