BreastNCT00845078
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
An observational study of Breast and Radiotherapy, run by University of Pittsburgh.
Trial summary
This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast, Radiotherapy, Aesthetics
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to not given
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy
Who may be able to join
- Breast cancer requiring mastectomy and post-mastectomy radiation
- Desire for breast reconstruction after mastectomy
Who cannot join
- Inflammatory breast cancer
- Age < 18 years old
- No desire for breast reconstruction
- Women without need for postmastectomy radiation
About this study
This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study.
The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
Read the detailed description
Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)
We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
- Conditions
- Breast, Radiotherapy, Aesthetics, Treatment Outcome, Surgical Reconstruction
- Keywords
- Breast, Radiotherapy, Esthetics, Treatment Outcome, Reconstructive Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Immediate reconstruction followed by radiation therapy | |
| 2 | Radiation therapy followed by delayed reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic breast scores
Measured: preoperative, 1 month, 6 months, 12 months, 24 months
Secondary outcomes (2)
Quality of life (SF36)
Measured: preoperative, 1 month, 6 months, 12 months, 24 months
Patient Breast aesthetic perception (BR23)
Measured: preoperative, 1 month, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BreastStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio A Clavijo-Alvarez, MD, Principal investigator, University of PittsburghMichael L Gimbel, MD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845078
- Sponsor's protocol ID
- PRO07120002
- Status last verified
- Feb 2009
- First submitted
- 13 Feb 2009
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007.
PubMed 11373553Tran NV, Chang DW, Gupta A, Kroll SS, Robb GL. Comparison of immediate and delayed free TRAM flap breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2001 Jul;108(1):78-82. doi: 10.1097/00006534-200107000-00013.
PubMed 11420508Tran NV, Evans GR, Kroll SS, Baldwin BJ, Miller MJ, Reece GP, Robb GL. Postoperative adjuvant irradiation: effects on tranverse rectus abdominis muscle flap breast reconstruction. Plast Reconstr Surg. 2000 Aug;106(2):313-7; discussion 318-20. doi: 10.1097/00006534-200008000-00011.
PubMed 10946929Kroll SS, Robb GL, Reece GP, Miller MJ, Evans GR, Baldwin BJ, Wang B, Schusterman MA. Does prior irradiation increase the risk of total or partial free-flap loss? J Reconstr Microsurg. 1998 May;14(4):263-8. doi: 10.1055/s-2007-1000179.
PubMed 9618094Kroll SS, Coffey JA Jr, Winn RJ, Schusterman MA. A comparison of factors affecting aesthetic outcomes of TRAM flap breast reconstructions. Plast Reconstr Surg. 1995 Sep;96(4):860-4. doi: 10.1097/00006534-199509001-00015.
PubMed 7652060
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT00845078
- Acronym / sponsor ID
- PRO07120002
- Conditions
- Breast, Radiotherapy, Aesthetics, Treatment Outcome, Surgical Reconstruction
- Keywords
- Breast, Radiotherapy, Esthetics, Treatment Outcome, Reconstructive Surgical Procedures
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2008
- First posted
- 16 Feb 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.
This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study.
The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
Detailed description
Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)
We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Immediate reconstruction followed by radiation therapy |
| 2 | – | –Radiation therapy followed by delayed reconstruction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy
Key inclusion criteria (2 listed)
- Breast cancer requiring mastectomy and post-mastectomy radiation
- Desire for breast reconstruction after mastectomy
Key exclusion criteria (4 listed)
- Inflammatory breast cancer
- Age < 18 years old
- No desire for breast reconstruction
- Women without need for postmastectomy radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aesthetic breast scores
Time frame: preoperative, 1 month, 6 months, 12 months, 24 months
2 secondary outcomes
Quality of life (SF36)
Time frame: preoperative, 1 month, 6 months, 12 months, 24 months
Patient Breast aesthetic perception (BR23)
Time frame: preoperative, 1 month, 6 months, 12 months, 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Background: PubMed 11373553Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007.
- Results publication: PubMed 11420508Tran NV, Chang DW, Gupta A, Kroll SS, Robb GL. Comparison of immediate and delayed free TRAM flap breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2001 Jul;108(1):78-82. doi: 10.1097/00006534-200107000-00013.
- Results publication: PubMed 10946929Tran NV, Evans GR, Kroll SS, Baldwin BJ, Miller MJ, Reece GP, Robb GL. Postoperative adjuvant irradiation: effects on tranverse rectus abdominis muscle flap breast reconstruction. Plast Reconstr Surg. 2000 Aug;106(2):313-7; discussion 318-20. doi: 10.1097/00006534-200008000-00011.
- Results publication: PubMed 9618094Kroll SS, Robb GL, Reece GP, Miller MJ, Evans GR, Baldwin BJ, Wang B, Schusterman MA. Does prior irradiation increase the risk of total or partial free-flap loss? J Reconstr Microsurg. 1998 May;14(4):263-8. doi: 10.1055/s-2007-1000179.
- Results publication: PubMed 7652060Kroll SS, Coffey JA Jr, Winn RJ, Schusterman MA. A comparison of factors affecting aesthetic outcomes of TRAM flap breast reconstructions. Plast Reconstr Surg. 1995 Sep;96(4):860-4. doi: 10.1097/00006534-199509001-00015.
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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.
Julio A Clavijo-Alvarez, MD principal investigator
University of Pittsburgh
Michael L Gimbel, MD study director
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Breast and Radiotherapy, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Aesthetic breast scores (time frame: preoperative, 1 month, 6 months, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00845078, which also lists 5 linked publications.
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 27 Apr 2017.