Clinical trial NCT03529565: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Pain
Breast Carcinoma Metastatic in the Bone
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with breast cancer with radiographic evidence of bone metastases

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.

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

Primary outcomes:
measure: Plasma histamine levels
timeFrame: Up to 6 months
Secondary outcomes:
measure: Calcitonin gene-related peptide (CGRP)
timeFrame: Up to 6 months
measure: Stem cell factor (SCF)
timeFrame: Up to 6 months
measure: angiotensin II (Ang II) Substance P
timeFrame: Up to 6 months
measure: angiotensin 1-7 (Ang1-7) levels
timeFrame: Up to 6 months
measure: Histamine system involvement
timeFrame: Up to 6 months
measure: Change in bone structural properties
timeFrame: Baseline up to 1 month
measure: Change in patient quality of life
timeFrame: Baseline up to 1 month
measure: Change in physical and psychological function
timeFrame: Baseline up to 1 month
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Doris Brown
role: PRINCIPAL_INVESTIGATOR
References: