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Spots Global Cancer Trial Database for Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone

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Trial Identification

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

Official Title: The Role of Histamine in Breast Cancer Bone Pain

Study ID: NCT03529565

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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Contact Details

Name: Doris Brown

Affiliation: Wake Forest University Health Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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