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.
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.
Study Type
OBSERVATIONAL
Enrollment
17
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Plasma histamine levels
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).
Time frame: Up to 6 months
Calcitonin gene-related peptide (CGRP)
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.
Time frame: Up to 6 months
Stem cell factor (SCF)
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.
Time frame: Up to 6 months
angiotensin II (Ang II) Substance P
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.
Time frame: Up to 6 months
angiotensin 1-7 (Ang1-7) levels
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.
Time frame: Up to 6 months
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Ancillary studies
Histamine system involvement
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).
Time frame: Up to 6 months
Change in bone structural properties
The thickness of the cortical bone within the irradiated volume will be measured.
Time frame: Baseline up to 1 month
Change in patient quality of life
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.
Time frame: Baseline up to 1 month
Change in physical and psychological function
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.
Time frame: Baseline up to 1 month