Evaluating the ability of exercise to suppress tumour growth in advanced breast cancer patients with osteolytic bone metastases.

Not Applicable

Completed

• Conditions: Breast Cancer; Bone Metastases; Cancer - Bone; Cancer - Breast

• Registration Number: ACTRN12616001368426
• Lead Sponsor: Edith Cowan University

Brief Summary

Data is still being analysed. However, the primary outcome ( to establish the safety and feasibility of exercise for advanced breast cancer patients with osteolytic bone metastases ) was positive. That is, our targeted exercise program was safe, and feasibly delivered, with no skeletal adverse events associated with bone metastatic lesions. All results will be published as analyses of the full data-set are completed through-out 2019.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-04
• Study Completion: 2019-07-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

* Female, aged greater than or equal to 18 years.
* Histologically documented breast cancer.
* Stable solitary or multiple metastatic osteolytic lesions in the thoracic or lumbar spine.
* Greater than or equal to 3 months since last change of current primary therapies.
* Greater than or equal to 3 months since commencement of new primary therapies.
* Greater than or equal to 4 weeks since last major surgery and fully recovered
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
* Medical clearance by treating physician to participate in exercise

Exclusion Criteria

* Brain metastases or small cell neuroendocrine tumours’
* Currently receiving radiotherapy for thoracic or lumbar spinal metastases. Patients are permitted to receive radiotherapy for non-spinal bone metastases only during this intervention.
* Currently receiving any other experimental treatments or non-approved therapies.
* Regular participation in structured aerobic exercise greater than or equal to 2 days per week.
* Regular participation in structured resistance exercise greater than or equal to 2 days per week.
* Cardiovascular or neurological disorders that could inhibit exercise participation.
* Diminished legal or perceived psychological capacity to given informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumour Morphology<br><br>Tumour morphology will be measured using axial T1-weighted magnetic resonance imaging (MRI) scans (1.5T, Magnetom Essenza, Siemens, Victoria, Australia) in locations where osteolytic lesions have been identified in patients with bone metastases at either thoracic or lumbar spinal regions. Location of metastatic lesions will be previously identified through bone scans provided by the oncologist prior to referral to this study. All scans will be performed on the same MRI machine by the same radiologist who will also report on all images obtained.[Week 0 (baseline) to Week 12 (post-intervention)];Tumour Activity<br><br>Metastatic tumour biomarkers, HIF-1.alpha and TGF-beta will be serologically examined to measure hypoxic activity and transformation-growth activity respectively; identified as synergistic drivers of metastatic tumour progression.[Week 0 (baseline) to Week 12 (post-intervention)]