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

Wake Forest University (WFU)

Status: Terminated

Conditions: Bone Pain; Breast Carcinoma Metastatic in the Bone

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03529565

P30CA012197 (U.S. NIH Grant/Contract)

IRB00048455

CCCWFU 02217 (Other Identifier)

NCI-2018-00277 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 1 patient group

Ancillary-Correlative (biospecimen collection)

Description:

Participants undergo collection of blood samples for histamine level analysis via ELISA.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Biospecimen Collection

Other: Laboratory Biomarker Analysis