PRADA

Primary Radiotherapy And DIEP Flap Reconstruction (PRADA) study.

Overview

 

Many women with breast cancer now live for decades after their breast cancer treatment. In view of this, modern breast reconstruction surgery after mastectomy for breast cancer aims to reproduce as natural a breast shape as possible. Keeping a natural breast appearance has been shown to be very important to a woman's emotional and psychological recovery.

Breast cancer treatment often includes a combination of surgery, chemotherapy, radiotherapy, anticancer tablets such as Tamoxifen, and newer targeted drugs such as Herceptin. Radiotherapy is usually given after surgery. However, radiotherapy after mastectomy and breast reconstruction can damage the 'new' breast giving a less good breast shape and appearance in the longer term. Also, if recovery is slow following surgery, the radiotherapy is delayed which may reduce its effectiveness. Changing the order of treatments has been shown to be safe and effective for chemotherapy, Herceptin and anticancer tablets but we have very little information on giving radiotherapy before breast cancer surgery.

The investigators want to find out if giving radiotherapy before mastectomy and reconstruction alters surgical complication rates and they want to evaluate the appearance of the reconstructed breast when radiotherapy is given before surgery


Aims

 

Primary Outcome Measures:

  • Number of participants with presence of open breast wound [ Time Frame: 4 weeks after mastectomy and DIEP flap reconstruction ]Presence of open breast wound at 4 weeks after mastectomy & DIEP flap reconstruction


Secondary Outcome Measures:

  • Volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging [ Time Frame: 3 months and 12 months after surgery ]Difference in volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging at 3 months and 12 months after surgery.

  • Patient satisfaction [ Time Frame: 3 months and 12 months after surgery ]Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, three months after, and 12 months after surgery.

  • Applanation tonometry measure of breast compressibility between the reconstructed and non-reconstructed breast [ Time Frame: 3 months and 12 months after surgery ]Difference in breast compressibility between the reconstructed and non-reconstructed breast using applanation tonometry at 3 months and 12 months following surgery.


Inclusion criteria

 

  • Women >18 years with histopathologically-confirmed breast cancer, who:
  • require mastectomy for any reason (e.g. extensive disease, failed conservative management etc.)
  • adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy

Exclusion Criteria:

  • Inability to give informed consent
  • MDM unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings ie mastectomy pathology required for MDM to decide on need/ target volume for post-mastectomy RT
  • Severe chemotherapy toxicity affecting treatment planning schedule

Further information

 

For more information about this trial please contact Fiona MacNeill, Chief Investigator, at fiona.macneill@rmh.nhs.uk or contact Melissa Tan, Trial Co-ordinator at MelissaLeyHui.Tan3@rmh.nhs.uk.

You can also find information about the PRADA study on the Health Research Association website here.