Breast CancerNCT00859157
Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
An observational study of Breast Cancer and Pain, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Pain, Perioperative/Postoperative Complications
- What is being tested?
- therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
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.
Read the 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).
- Being tested
- therapeutic conventional surgery
- Keywords
- perioperative/postoperative complications, pain, ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative Complications, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic conventional surgeryProcedure or surgery
Patients undergo tumescent or standard mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients undergo standard mastectomy. Receives: Procedure: therapeutic conventional surgery | |
| Group 2 | Patients undergo tumescent mastectomy. Receives: Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain at 1 and at 7-10 days after mastectomy
Measured: 7-10 days
Secondary outcomes (6)
Number of acetaminophen/oxycodone tablets taken
Measured: 7-10 days after surgery
Total time of operation from breast incision to completion of wound closure
Measured: Day of surgery
Time of operation from first incision to completion of both superior and inferior skin flaps
Measured: Day of surgery
Estimated blood loss
Measured: Day of surgery
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
Measured: 7-10 days after surgery
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively
Measured: Up to 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steve R. Martinez, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859157
- Sponsor's protocol ID
- 246600
- Other IDs
- UCD-CCSO001, 200816282, CDR0000633754
- Status last verified
- Jun 2017
- First submitted
- 7 Mar 2009
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
- ClinicalTrials.gov ID
- NCT00859157
- Acronym / sponsor ID
- 246600
- Keywords
- perioperative/postoperative complications, pain, ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: therapeutic conventional surgeryPatients undergo standard mastectomy. |
| Group 2 | – | Procedure: therapeutic conventional surgeryPatients undergo tumescent mastectomy. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (age 18 or more) women with histologic diagnosis of stage 0, I, II, III breast cancer undergoing mastectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic conventional surgeryPatients undergo tumescent or standard mastectomy | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Post-operative pain at 1 and at 7-10 days after mastectomy
Time frame: 7-10 days
6 secondary outcomes
Number of acetaminophen/oxycodone tablets taken
Time frame: 7-10 days after surgery
Total time of operation from breast incision to completion of wound closure
Time frame: Day of surgery
Time of operation from first incision to completion of both superior and inferior skin flaps
Time frame: Day of surgery
Estimated blood loss
Time frame: Day of surgery
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
Time frame: 7-10 days after surgery
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively
Time frame: Up to 10 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve R. Martinez, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Pain, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain at 1 and at 7-10 days after mastectomy (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.