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Acupuncture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome.

NCT07137221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2025-08-22

No results posted yet for this study

Summary

This is a prospective, single-center, non-interventional, non-pharmacological study.

In this study, postmenopausal patients with breast cancer in the adjuvant setting will be enrolled and treated with acupuncture to reduce hot flashes and other climacteric symptoms.

Conditions

Interventions

OTHER

Post menopausal breast cancer patients

All selected patients will undergo peripheral blood samplingfor the evaluation of inflammatory biomarkers and must have agreed to store and use part of their sample for research purposes. A panel of inflammatory cytokines (IFNγ, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-22, TNFα) will be detected by ELISA assay. Other biomarkers such as RANKL, OPG, Vitamin D levels, CTX, PTH will be evaluated by immunoenzymatic assays. In addition, mirNAs as mir-16 and mir-378 will be evaluated by RT-PCR. Glucose metabolic markers such as fasting glucose and insulin, HbA1c and other parameters such as calcemia, PTH, c-telopeptide etc. will be collected. In particular, the evaluation of the biomarkers will be done on plasma samples at different time points (previously the administration of 10 course of weekly acupuncture; at the end and 6 months after the end of acupuncture and at the time of symptoms recurrence.

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Anna Fedeli, Dr. · IRCCS IRST

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2020-12-30
Completion
2023-03-24

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137221 on ClinicalTrials.gov