The Role of Histamine in Breast Cancer Bone Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Plasma histamine levels
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnant women will be excluded
研究组 & 干预措施
Ancillary-Correlative (biospecimen collection)
Participants undergo collection of blood samples for histamine level analysis via ELISA.
干预措施: Biospecimen Collection (Procedure)
Ancillary-Correlative (biospecimen collection)
Participants undergo collection of blood samples for histamine level analysis via ELISA.
干预措施: Laboratory Biomarker Analysis (Other)
Ancillary-Correlative (biospecimen collection)
Participants undergo collection of blood samples for histamine level analysis via ELISA.
干预措施: Quality-of-Life Assessment (Other)
Ancillary-Correlative (biospecimen collection)
Participants undergo collection of blood samples for histamine level analysis via ELISA.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Plasma histamine levels
时间窗: 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).
次要结局
- Histamine system involvement(Up to 6 months)
- Change in patient quality of life(Baseline up to 1 month)
- Change in physical and psychological function(Baseline up to 1 month)
- Calcitonin gene-related peptide (CGRP)(Up to 6 months)
- Change in bone structural properties(Baseline up to 1 month)
- angiotensin 1-7 (Ang1-7) levels(Up to 6 months)
- Stem cell factor (SCF)(Up to 6 months)
- angiotensin II (Ang II) Substance P(Up to 6 months)