NCT03529565

Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone

The Role of Histamine in Breast Cancer Bone Pain

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bone Pain
• Breast Carcinoma Metastatic in the Bone

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-01-31
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2018-05-18
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States