Breast Cancer Clinical Trial
Official title:
Challenging the Paradigm in Pain Relief for Advanced Breast and Prostate Cancer Patients With Vertebral Metastasis: Vertebral Augmentation With Cement Plus Radiotherapy Versus Radiotherapy. A Randomized, Prospective, Double Blind Pilot Study
The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The investigators hypothesize that, by combining vertebral augmentation with cement and radiotherapy, they could achieve an enhancement in pain relief and level of activities, as well as a decrease in the side effects of multiple medications used for pain control.
Included patients presenting with spinal metastasis secondary to breast or prostate cancer
are randomized to two groups, intervention and control. Both groups receive standard
radiotherapy, which is currently the gold standard of care for such patients. The
intervention group will also receive a vertebroplasty [single or multiple level(s)], while
the control group will receive a simulated vertebroplasty, where local anesthesia and gentle
hand manipulation will be used but the vertebra will not be accessed. The primary outcome is
pain relief, though other factors such as quality of life and pain medications will also be
evaluated.
There will be an interim analysis after half of the patients have been treated with a
follow-up of 3 months. In the analysis, comparisons will be made between the two groups and
each patient's individual progress will also be analyzed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |