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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 78 (estimated) |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beaumont, Dublin) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2028 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07672392 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
- Study coordinator: Arnold Hill, MB, BCh, BAO, MCh, FRCSI
- Email: adkhill@rcsi.com
- Phone: +35318093000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.