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

NCT03529565 | Terminated

• 4 other identifiers: IRB00048455NCI-2018-00277CCCWFU 02217P30CA012197
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Pain; Breast Carcinoma Metastatic in the Bone

Outcome Measures

Primary Outcomes (1)

• Plasma histamine levels

  To correlate levels of histamine in plasma with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, analysis of variance (ANOVA) will be used. The histamine levels will be transformed to satisfy the conditional normality assumption if needed. Linear regression models will be used to relate histamine levels (outcome variable) with the pain groups (covariate of interest).

  Up to 6 months

Secondary Outcomes (8)

• Calcitonin gene-related peptide (CGRP)

  Up to 6 months

• Stem cell factor (SCF)

  Up to 6 months

• angiotensin II (Ang II) Substance P

  Up to 6 months

• angiotensin 1-7 (Ang1-7) levels

  Up to 6 months

• Histamine system involvement

  Up to 6 months

Study Arms (1)

Ancillary-Correlative (biospecimen collection)

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

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

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood

Ancillary-Correlative (biospecimen collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (biospecimen collection)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Ancillary-Correlative (biospecimen collection)

Questionnaire Administration OTHER

Ancillary studies

Ancillary-Correlative (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with breast cancer with radiographic evidence of bone metastases

You may qualify if:

• 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

You may not qualify if:

• Pregnant women will be excluded

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Doris Brown

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 18, 2018
• Study Start: January 31, 2019
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

US (1)