Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone
Study Details
Study Description
Brief Summary
This trial studies histamine and bone pain association in participants with breast cancer that has spread to the bone. Studying histamine levels in samples of blood from participants with breast cancer in the laboratory may help doctors learn more about reducing cancer bone pain and preventing further bone metastasis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PRIMARY OBJECTIVES:
- 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:
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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.
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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).
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ancillary-Correlative (biospecimen collection) Participants undergo collection of blood samples for histamine level analysis via ELISA. |
Procedure: Biospecimen Collection
Undergo collection of blood
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Plasma histamine levels [Up to 6 months]
To correlate levels of histamine in plasma with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, analysis of variance (ANOVA) will be used. The histamine levels will be transformed to satisfy the conditional normality assumption if needed. Linear regression models will be used to relate histamine levels (outcome variable) with the pain groups (covariate of interest).
Secondary Outcome Measures
- Calcitonin gene-related peptide (CGRP) [Up to 6 months]
Levels of CGRP will be collected. Statistical analysis will correlate CGRP with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
- Stem cell factor (SCF) [Up to 6 months]
Levels of SCF will be collected. Statistical analysis will correlate SCF with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
- angiotensin II (Ang II) Substance P [Up to 6 months]
Levels of Ang II will be collected. Statistical analysis will correlate Ang II with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
- angiotensin 1-7 (Ang1-7) levels [Up to 6 months]
Levels of Ang 1-7 will be collected. Statistical analysis will correlate Ang 1-7 with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
- Histamine system involvement [Up to 6 months]
Will perform next generation ribonucleic acid (RNA) sequences using whole blood to determine whether histamine system is involved in the development of cancer-induced bone pain (CIBP).
- Change in bone structural properties [Baseline up to 1 month]
The thickness of the cortical bone within the irradiated volume will be measured.
- Change in patient quality of life [Baseline up to 1 month]
The change in patient quality of life will be assessed by the visual analogue scale (VAS) pain scale. The total score range is 0-10 with higher scores denoting worse outcomes.
- Change in physical and psychological function [Baseline up to 1 month]
To be measured using the EORTC QLQ-BM22 quality of life questionnaire. It's divided into two categories, giving a single value: symptoms and functions. A high score indicates a high level of symptoms and a high level of functioning. The score range is 22-88.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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Non-weight bearing sites: up to 3 consecutive ribs, humerus, fibula, radius +/- ulna, clavicle, sternum, scapula, pubis
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Patients with and without pain related to the radiographically documented metastases are eligible for study
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Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion Criteria:
- Pregnant women will be excluded
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Doris Brown, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00048455
- NCI-2018-00277
- CCCWFU 02217
- P30CA012197