Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women will be excluded

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT03529565

Recruitment Status:

Recruiting

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States More Info
Doris R. Brown
Contact
336-713-3600
[email protected]
Doris R. Brown
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT03529565

Recruitment Status:

Recruiting

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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