NCT00859157

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

5.3 years

First QC Date

March 7, 2009

Last Update Submit

June 19, 2017

Conditions

Breast CancerPainPerioperative/Postoperative Complications

Keywords

perioperative/postoperative complicationspainductal breast carcinoma in situinvasive ductal breast carcinomainvasive lobular breast carcinomastage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

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

    7-10 days

Secondary Outcomes (6)

  • Number of acetaminophen/oxycodone tablets taken

    7-10 days after surgery

  • Total time of operation from breast incision to completion of wound closure

    Day of surgery

  • Time of operation from first incision to completion of both superior and inferior skin flaps

    Day of surgery

  • Estimated blood loss

    Day of surgery

  • Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours

    7-10 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

Group 1

Patients undergo standard mastectomy.

Procedure: therapeutic conventional surgery

Group 2

Patients undergo tumescent mastectomy.

Procedure: therapeutic conventional surgery

Interventions

therapeutic conventional surgeryPROCEDURE

Patients undergo tumescent or standard mastectomy

Group 1Group 2

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult (age 18 or more) women with histologic diagnosis of stage 0, I, II, III breast cancer undergoing mastectomy.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsPainPostoperative ComplicationsCarcinoma, Intraductal, NoninfiltratingCarcinoma, Ductal, BreastCarcinoma, Lobular

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, Ductal

Study Officials

  • Steve R. Martinez, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2009

First Posted

March 10, 2009

Study Start

October 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations

US(1)