Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone
-
- STATUS
- Recruiting
-
- days left to enroll
- 50
-
- participants needed
- 30
-
- sponsor
- Wake Forest University Health Sciences
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.
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.
Details
| Condition | Bone Pain, Breast Carcinoma Metastatic in the Bone |
|---|---|
| Treatment | laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, biospecimen collection |
| Clinical Study Identifier | NCT03529565 |
| Sponsor | Wake Forest University Health Sciences |
| Last Modified on | 3 May 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer