Impact of Radiotherapy on Patients Undergoing DIEP Flap Breast Reconstruction

NCT03072316 | Unknown

• 1 other identifier: CCR 4283
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators intend to undertake a study to investigate the effect of radiotherapy on deep inferior epigastric perforator flap reconstructions (DIEP). Adjuvant post-mastectomy radiotherapy (PMRT) is offered to women at high risk of chest wall recurrence. The perceived detrimental effect of radiotherapy on an immediate breast reconstruction and the "one-off" nature of autologous reconstruction leads some surgeons to recommend delayed reconstruction after mastectomy or to use a temporising implant with a view to planned exchange to autologous reconstruction after radiotherapy. However, there remains significant uncertainty in the literature about the impact of radiotherapy on autologous reconstructions. This study is a mixed methology study using patient reported outcome measures (PROMS), applanation tonometry (measure of breast compressibility), semi-structured interviews and 3 dimensional photography analysis to compare the aesthetic and impact on quality of life on the following groups of patients: Patient groups:

1. 1.Unilateral skin sparing mastectomy (SSM) with immediate DIEP flap reconstruction and PMRT (cases)
2. 2.Unilateral SSM with immediate DIEP flap reconstruction and no PMRT (controls)
3. 3.Unilateral simple mastectomy, PMRT, and subsequent delayed DIEP flap reconstruction (controls)
4. 4.Unilateral SSM with temporizing implant, PMRT and subsequent conversion to DIEP (controls)

Conditions

Breast Cancer

Keywords

breast cancer; mastectomy; deep inferior perforator flap reconstruction; post mastectomy radiotherapy

Outcome Measures

Primary Outcomes (1)

• The difference in patient satisfaction score between patients with an irradiated DIEP flap (group (a)) and patients with a DIEP flap who have not undergone PMRT (group (b)) using "satisfaction with reconstructed breast" question of the BREAST-Q.

  The difference in (mean or median) patient satisfaction score (ranging from 0-100) between patients with an irradiated DIEP flap (group (a)) and patients with a DIEP flap who have not undergone PMRT (group (b)) using the "satisfaction with reconstructed breast" subscale of the postoperative reconstruction module of the BREAST-Q questionnaire.

  Day 1

Secondary Outcomes (11)

• The difference in scores in other subscales from the BREAST-Q questionnaire between patients with an irradiated DIEP flap (group (a)) and patients with a DIEP flap who have not undergone PMRT (group (b)).

  Day 1

• The difference in patient satisfaction and all subscales between patients with an irradiated DIEP flap (group (a)) and patients who underwent PMRT prior to DIEP flap (group (c) and group (d)) using BREAST-Q scores as above.

  Day 1

• Volume and symmetry assessment of the reconstructed breast using 3D surface imaging This would consist of comparing volume and symmetry assessment between groups (a) and (b), groups (a) and (c), and groups (a) and (d).

  Day 1

• Panel assessment by independent panel of the reconstruction using 3D surface imaging.

  Day 1

• Applanation tonometry for assessment of the consistency of the reconstructed breast. This will consist of comparing breast compressibility in the reconstructed breast between groups (a) and (b), groups (a) and (c), and groups (a) and (d).

  Day 1

Study Arms (4)

SSM immediate DIEP

Unilateral skin sparing mastectomy with immediate DIEP

Other: 3D surface imaging; Other: semi-structured interview; Other: applanation tonometry

SSM immediate DIEP and PMRT

Unilateral skin sparing mastectomy with immediate DIEP flap reconstruction and post mastectomy radiotherapy

Other: 3D surface imaging; Other: semi-structured interview; Other: applanation tonometry

mastectomy, PMRT, delayed DIEP

simple mastectomy, post mastectomy radiotherapy adn then delayed DIEP reconstruction

Other: 3D surface imaging; Other: semi-structured interview; Other: applanation tonometry

SSM, temporizing implant, PMRT then DIEP

Unilateral SSM with temporizing implant, PMRT and subsequent

Other: 3D surface imaging; Other: semi-structured interview; Other: applanation tonometry

Interventions

3D surface imaging OTHER

3D photography

SSM immediate DIEP; SSM immediate DIEP and PMRT; SSM, temporizing implant, PMRT then DIEP; mastectomy, PMRT, delayed DIEP

semi-structured interview OTHER

qualitative analysis using semi structured interview

SSM immediate DIEP; SSM immediate DIEP and PMRT; SSM, temporizing implant, PMRT then DIEP; mastectomy, PMRT, delayed DIEP

applanation tonometry OTHER

measurement of breast compressibility

SSM immediate DIEP; SSM immediate DIEP and PMRT; SSM, temporizing implant, PMRT then DIEP; mastectomy, PMRT, delayed DIEP

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient who has undergone unilateral DIEP reconstruction for breast cancer at the Royal Marsden NHS Foundation Trust

You may qualify if:

• Women who have undergone one of the treatment sequences above (a) - (d)
• Patient groups:
• Unilateral skin sparing mastectomy (SSM) with immediate DIEP flap reconstruction and PMRT (cases)
• Unilateral SSM with immediate DIEP flap reconstruction and no PMRT (controls)
• Unilateral simple mastectomy, PMRT, and subsequent delayed DIEP flap reconstruction (controls)
• Unilateral SSM with temporizing implant, PMRT and subsequent conversion to DIEP (controls)
• Patients of any age will be included
• Patients who are between one and five years post initial breast reconstruction surgery or radiotherapy (which ever is most recent)

You may not qualify if:

• Women who have undergone bilateral mastectomy, even if the contralateral mastectomy was asynchronous.
• Women who are less than one year from their last radiotherapy treatment or from their DIEP flap reconstruction.
• Patients who have had more than one implant based operation before DIEP flap (revision surgery to the implant implies that an implant based reconstruction was the primary intent and therefore the DIEP flap is a 'salvage' procedure) or if it is documented to be a salvage reconstruction.
• Women who have developed recurrent / distant disease.
• Women who are unable to stand for the 3D imaging (approximately 10 minutes)
• Women who are unable to complete the English language questionnaire or interview (i.e. learning difficulties or patients who do not have adequate English language skills).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, London, SW3 6JJ, United Kingdom

RECRUITING

Related Publications (1)

• O'Connell RL, Di Micco R, Khabra K, Kirby AM, Harris PA, James SE, Power K, Ramsey KWD, Rusby JE. Comparison of Immediate versus Delayed DIEP Flap Reconstruction in Women Who Require Postmastectomy Radiotherapy. Plast Reconstr Surg. 2018 Sep;142(3):594-605. doi: 10.1097/PRS.0000000000004676.

  PMID: 29927832 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Rusby, DM FRCS

  The Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel O'Connell, MBBSBScMRCS

CONTACT

07786254252; roconnell@doctors.org.uk

Jennifer Rusby, DM FRCS

CONTACT

02086426011; jennifer.rusby@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: March 7, 2017
• Study Start: January 14, 2016
• Primary Completion: January 14, 2018
• Study Completion: January 14, 2018
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

GB (1)