Advanced Cancer Clinical Trial
Official title:
Exercise Prescription in Patients With Bone Metastases: Identifying Clinical Tools to Overcome Clinician Concerns Regarding Skeletal Related Events (Ex-Met Study)
Cancer which has spread to the bone, causing bone metastases (bone tumours) can weaken bone health and increase risk of fractures (breaks). Consequently, patients can be unsure whether to exercise and health professionals can be unsure what exercise advice is suitable. Despite this, it is well known that exercise improves quality-of-life for patients with bone metastases and therefore it is important that exercise is prescribed to these patients. This study aims to increase understanding of the link between daily exercise and risk of fracture in patients with bone metastases.
It remains unclear if being physically active increases the risk of skeletal-related events in patients with bone metastases. Many health professionals report fracture risk as the primary concern with exercise prescription, despite a recognition of the importance of exercise participation. Consequently, health professionals can be hesitant to offer exercise advice and many patients are physically inactive. With increasing evidence supporting the benefits of exercise in metastatic bone disease, there is a need to address exercise-related concerns. Clinical scoring systems such as Mirel's classification, are considered predictive of pathological fracture risk. While scoring algorithms have considerable potential to inform exercise eligibility in this population, to date the applicability of such clinical measures for exercise prescription have been inadequately studied. This study will examine the relationship between habitual physical activity, captured objectively by accelerometry, and skeletal related events (pathologic fracture, spinal cord compression, necessity for radiation to bone or surgery to bone pathological fracture) in patients with metastatic disease (n=100). Clinical data including fracture risk and Skeletal Related Events (SREs), Physical Activity (PA) data and subjective measures of pain, sleep, Quality of Life (QoL) and exercise barriers and benefits will be collected at baseline. Fracture risk will be determined at baseline using Mirel's Classification, which will be assessed by a radiologist affiliated with the study research team. With treatment advances, patients with bone metastases secondary to advanced cancer are living longer. Consequently, optimising quality-of-life is a key priority and exercise has many recognised benefits in this domain. This research will explore the association between daily activity levels and skeletal complications in patients with bone metastases, by examining methods of identifying patients who are suitable to exercise, therefore improving exercise prescription practice and exercise participation safety. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
| Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
| Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
| Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
| Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
| Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
| Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 | |
| Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 |