Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Post-operative exercise program after DIEP flap breast reconstruction

Official title: The Effect of a Post-operative Exercise Programme Versus Standard Care on Physical Fitness of Patients With Breast Cancer Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Reconstruction Surgery

Run by Royal College of Surgeons, Ireland · NCT07672392 · Data updated 2026-11-12

This trial tests whether a structured 12-week post-operative exercise program can improve fitness and recovery for people having DIEP flap breast reconstruction after mastectomy.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment78 (estimated)
SponsorRoyal College of Surgeons, Ireland
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beaumont, Dublin)
StatusRecruiting
StartedAugust 1, 2024
Main results expectedDecember 30, 2027
Study endsDecember 30, 2028
Registry record updatedJune 26, 2026
Trial IDNCT07672392 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women 18 years or older undergoing mastectomy with planned DIEP flap reconstruction and fluent in English.

Probably not a fit

Patients who have advanced disease with skin involvement or those undergoing non-DIEP reconstruction may not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls women undergoing mastectomy with DIEP flap reconstruction to receive a structured, 12-week post-operative exercise program. The trial will measure patient-reported outcomes and functional performance, along with body composition, strength, recovery, complications, hospital stay, and time to return to daily activities. Secondary aims include effects on psychological health, body image, adherence, safety, and an exploratory health-economic analysis comparing costs and potential savings with standard care. The study is led by the Royal College of Surgeons in Ireland with Beaumont RCSI Cancer Centre as the site, focusing on feasibility and potential benefits of integrating exercise into post-reconstruction care.

Why it matters

Potential benefit: If successful, patients may experience faster recovery, improved physical function, and better quality of life after DIEP flap reconstruction.

How similar studies have gone: Previous research suggests exercise can improve treatment tolerance, fatigue, and quality of life in cancer patients, supporting potential benefit for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Women aged 18 years and older
2. Candidates who have already been selected to undergo mastectomy and reconstruction by the breast MDT for the following indications:

   1. Genetic mutation carriers undergoing risk-reducing mastectomy.
   2. Ductal carcinoma in situ (DCIS) requiring mastectomy.
   3. Early invasive breast cancer requiring mastectomy.
   4. The tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or pectoralis major muscle (as proven on MRI).
3. Candidates for breast reconstruction with DIEP.
4. Fluent in English
5. Fit for general anaesthetic Signed informed consent form

Exclusion Criteria:

1. Advanced breast cancer with skin involvement.
2. Undergoing bilateral DIEP reconstruction or other forms of breast reconstruction (e.g., TRAM, implant-based, LD flap).
3. Pregnancy
4. Lactation Patients with insufficient English to sign an informed consent (i.e. interpreter required).

Where it's running

  • Beaumont RCSI Cancer Centre
    Beaumont, Dublin, Ireland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.