RecruitingNot ApplicableNCT07672392

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


Sponsor

Royal College of Surgeons, Ireland

Enrollment

78 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria9

  • Women aged 18 years and older
  • Candidates who have already been selected to undergo mastectomy and reconstruction by the breast MDT for the following indications:
  • Genetic mutation carriers undergoing risk-reducing mastectomy.
  • Ductal carcinoma in situ (DCIS) requiring mastectomy.
  • Early invasive breast cancer requiring mastectomy.
  • 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).
  • Candidates for breast reconstruction with DIEP.
  • Fluent in English
  • Fit for general anaesthetic Signed informed consent form

Exclusion Criteria4

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

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Interventions

BEHAVIORALStructured 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.


Locations(1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, Ireland

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NCT07672392


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