Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone
Keywords
Abstract
Description
PRIMARY OBJECTIVES:
I. To correlate levels of histamine in plasma with pain scores in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy.
SECONDARY OBJECTIVES:
I. To perform exploratory studies with additional markers not mentioned, including calcitonin gene-related peptide (CGRP), stem cell factor (SCF), angiotensin II (Ang II) substance P, angiotensin 1-7 (Ang1-7), may be performed at the investigator's discretion.
II. To perform next generation ribonucleic acid (RNA) sequences using the whole blood to determine whether histamine system is involved in the development of cancer-induced bone pain (CIBP).
III. To assess the impact of pain response after radiotherapy on bone structural properties such as bone mineral density and cortical thickness, and patient quality of life, physical and psychological function.
OUTLINE:
Participants undergo collection of blood samples for histamine level analysis via enzyme-linked immunosorbent assay (ELISA).
After completion of study, participants are followed up at 1, 3, and 6 months.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 04/09/2018 |
| Estimated Enrollment Submitted: | 05/06/2018 |
| First Posted: | 05/17/2018 |
| Last Update Submitted: | 06/02/2020 |
| Last Update Posted: | 06/03/2020 |
| Actual Study Start Date: | 01/30/2019 |
| Estimated Primary Completion Date: | 07/31/2020 |
| Estimated Study Completion Date: | 07/31/2021 |
Condition or disease
Intervention/treatment
Procedure: Ancillary-Correlative (biospecimen collection)
Other: Ancillary-Correlative (biospecimen collection)
Other: Ancillary-Correlative (biospecimen collection)
Other: Ancillary-Correlative (biospecimen collection)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Ancillary-Correlative (biospecimen collection) Participants undergo collection of blood samples for histamine level analysis via ELISA. | Procedure: Ancillary-Correlative (biospecimen collection) Undergo collection of blood |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Breast cancer patients with radiographic evidence of bone metastases (by plain film, computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET] or bone scan) within 8 weeks of registration - Weight bearing sites: pelvis (excluding pubis), femur, sacrum and/or sacroiliac joints, tibia, up to 5 consecutive cervical, thoracic or lumbar vertebral bodies, lumbosacral spine - Non-weight bearing sites: up to 3 consecutive ribs, humerus, fibula, radius +/- ulna, clavicle, sternum, scapula, pubis - Patients with and without pain related to the radiographically documented metastases are eligible for study - Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: - Pregnant women will be excluded |
Outcome
Primary Outcome Measures
1. Plasma histamine levels [Up to 6 months]
Secondary Outcome Measures
1. Calcitonin gene-related peptide (CGRP) [Up to 6 months]
2. Stem cell factor (SCF) [Up to 6 months]
3. angiotensin II (Ang II) Substance P [Up to 6 months]
4. angiotensin 1-7 (Ang1-7) levels [Up to 6 months]
5. Histamine system involvement [Up to 6 months]
6. Change in bone structural properties [Baseline up to 1 month]
7. Change in patient quality of life [Baseline up to 1 month]
8. Change in physical and psychological function [Baseline up to 1 month]
