Poster Presentation 2025 National Cancer Survivorship Conference

Evaluating the addition of exercise or compression therapy to best-practice usual breast cancer care to prevent lymphoedema (the ACHIEVE trial): a protocol for a Phase III, multi-state, randomised controlled trial (#92)

Melanie Plinsinga 1 , Alexandra McCarthy 2 , Louise Koelmeyer 3 , Louisa Collins 4 , Christobel Saunders 5 , Christopher Pyke 6 , Hildegard Reul-Hirche 1 7 , Rosa Spence 1 8 , Sandra Hayes 8
  1. School of Health Sciences and Social Work, Griffith University, Nathan, Queensland, Australia
  2. Faculty of Health, Griffith University, Brisbane, Queensland, Australia
  3. Australian Lymphoedema Education, Research & Treatment (ALERT) Program, Faculty of Medicine, Health & Human Sciences, Macquarie University, Sydney, New South Wales, Australia
  4. Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia
  5. Department of Surgery, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia
  6. Mater Public and Private Hospital, Brisbane, Queensland, Australia
  7. Physiotherapy department, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
  8. Cancer Council Queensland, Fortitude Valley, Queensland, Australia

Aims: The primary aim of the trial is to determine whether, in addition to usual care, 6 months of exercise therapy or compression therapy prevents breast cancer-related lymphoedema. The secondary aims of the trial are to i) establish the effect of adding exercise or compression to usual breast cancer care on consumer-chosen health outcomes 12-months after breast surgery; and ii) determine the cost-effectiveness, productivity impacts and costs to government of adding exercise or compression to standard care.

Methods: A multi-state, phase III, randomised controlled trial, registered with the Australian New Zealand Clinical Trial Registry (target sample size: n=660; minimum 4 sites). People ≥18 years with (i) first diagnosis of invasive, uni- or bilateral breast cancer, (ii) removal of 5+ lymph nodes on one side, any number of positive nodes or receipt of neoadjuvant chemotherapy, and (iii) scheduled for surgery or receipt of radiation therapy to the axilla, will be recruited. Consenting participants will be randomly allocated (1:1:1) to exercise therapy (plus usual care), compression therapy (plus usual care) or usual care alone.

Intervention arms: Usual care: prospective surveillance of lymphoedema status with early intervention (typically using compression) if lymphoedema develops. Surveillance includes clinical assessment, alongside objective assessment of extracellular fluid and limb size at 3-, 6- and 12-months post-breast cancer surgery. Usual care+exercise: individualised, evidence-based exercise therapy (weekly target of 150 minutes of moderate-intensity, mixed-mode exercise) delivered via the telephone. Usual care+compression: provision of compression garment (class 1) to be worn daily (minimum of 12 hours; remove at night). Baseline assessment will occur between 1-4 weeks post-surgery. Follow up assessments will be scheduled at 3-, 6-, 12-, 24-months, and 5-years post-randomisation.

Planned dissemination: Findings will be disseminated via peer-reviewed publications, presentations at international lymphoedema, exercise and oncology conferences, and will inform workforce training, position statements and clinical guidelines.