Recruiting

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

ClinicalTrials.gov IDNCT07672392

PhaseNA

Enrollment78

SponsorRoyal College of Surgeons, Ireland

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Exercise

About this study

All patients undergoing mastectomy for breast cancer should be offered the option of reconstructive surgery. The Deep Inferior Epigastric Perforator Flap or DIEP reconstruction as it is commonly referred to, is becoming the favoured reconstruction by both patients and surgeons as it gives a great cosmetic outcome as well as being a good option for patients who may have to undergo radiotherapy treatment after their surgery. Exercise has been demonstrated in previous research to improve tolerance of treatment (particularly chemotherapy), post operative fatigue and the overall quality of life in patients undergoing cancer treatment. Furthermore, it has shown to improve survival in patients who are being treated for breast cancer. The investigators are undertaking this study to investigate whether a structured exercise programme will improve patients fitness after surgery and ultimately improve their recovery after their reconstructive surgery. To do this, half of the people taking part will be undertaking a structured exercise programme and the other half will not and will be assessing which group recover better after their surgery. Currently, no breast reconstruction patients in Ireland are receiving a formal "exercise prescription" after their surgery so will be looking to see if this helps people recover better before it is made standard care for every breast patient in Ireland.

Interventions

Behavioral: Structured individualised 12-week post operative exercise programme — Structured individualised 12-week post operative exercise programme based on ACSM oncology guidelines, incorporating aerobic, resistance and flexibility training delivered in person or via zoom.

Primary outcomes

Cardiorespiratory Fitness (Measured at baseline (recruitment), 6 months postoperatively and at 1 year postoperatively)

Eligibility information

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).

Study locations

Beaumont RCSI Cancer Centre, Beaumont, Dublin D09V2N0 Ireland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.