Bone PainNCT03529565
Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone
An observational study of Bone Pain and Breast Carcinoma Metastatic in the Bone, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Pain, Breast Carcinoma Metastatic in the Bone
- What is being tested?
- Biospecimen Collection, Laboratory Biomarker Analysis and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 18 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with breast cancer with radiographic evidence of bone metastases
Who may be able to join
- 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
Who cannot join
- Pregnant women will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: The Role of Histamine in Breast Cancer Bone Pain
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Bone Pain, Breast Carcinoma Metastatic in the Bone
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (biospecimen collection) | Participants undergo collection of blood samples for histamine level analysis via ELISA. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 months
Secondary outcomes (8)
Calcitonin gene-related peptide (CGRP)
Levels of CGRP will be collected. Statistical analysis will correlate CGRP with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
Measured: Up to 6 months
Stem cell factor (SCF)
Levels of SCF will be collected. Statistical analysis will correlate SCF with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
Measured: Up to 6 months
angiotensin II (Ang II) Substance P
Levels of Ang II will be collected. Statistical analysis will correlate Ang II with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
Measured: Up to 6 months
angiotensin 1-7 (Ang1-7) levels
Levels of Ang 1-7 will be collected. Statistical analysis will correlate Ang 1-7 with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, ANOVA will be used.
Measured: Up to 6 months
Histamine system involvement
Will perform next generation ribonucleic acid (RNA) sequences using whole blood to determine whether histamine system is involved in the development of cancer-induced bone pain (CIBP).
Measured: Up to 6 months
Change in bone structural properties
The thickness of the cortical bone within the irradiated volume will be measured.
Measured: Baseline up to 1 month
Change in patient quality of life
The change in patient quality of life will be assessed by the visual analogue scale (VAS) pain scale. The total score range is 0-10 with higher scores denoting worse outcomes.
Measured: Baseline up to 1 month
Change in physical and psychological function
To be measured using the EORTC QLQ-BM22 quality of life questionnaire. It's divided into two categories, giving a single value: symptoms and functions. A high score indicates a high level of symptoms and a high level of functioning. The score range is 22-88.
Measured: Baseline up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start31 Jan 2019
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Why it stopped: Low accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Doris Brown, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529565
- Sponsor's protocol ID
- IRB00048455
- Other IDs
- NCI-2018-00277, CCCWFU 02217, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2018
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Histamine in Breast Cancer Bone Pain
- ClinicalTrials.gov ID
- NCT03529565
- Acronym / sponsor ID
- IRB00048455
- Conditions
- Bone Pain, Breast Carcinoma Metastatic in the Bone
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accruals
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants undergo collection of blood samples for histamine level analysis via ELISA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with breast cancer with radiographic evidence of bone metastases
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- Pregnant women will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood | Procedure or surgery | Ancillary-Correlative (biospecimen collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (biospecimen collection) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Ancillary-Correlative (biospecimen collection) |
| Questionnaire AdministrationAncillary studies | Other | Ancillary-Correlative (biospecimen collection) |
Primary outcome
Plasma histamine levels
Time frame: Up to 6 months
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).
8 secondary outcomes
Calcitonin gene-related peptide (CGRP)
Time frame: Up to 6 months
Stem cell factor (SCF)
Time frame: Up to 6 months
angiotensin II (Ang II) Substance P
Time frame: Up to 6 months
angiotensin 1-7 (Ang1-7) levels
Time frame: Up to 6 months
Histamine system involvement
Time frame: Up to 6 months
Change in bone structural properties
Time frame: Baseline up to 1 month
Change in patient quality of life
Time frame: Baseline up to 1 month
Change in physical and psychological function
Time frame: Baseline up to 1 month
Results and safety
The study was stopped early (reason given: Low accruals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Brown principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Pain and Breast Carcinoma Metastatic in the Bone, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accruals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma histamine levels (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.