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

NCT07137221 | Completed

• 1 other identifier: IRSTB104
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Observational; postmonopausal; breast cancer; Hot Flashes; Acupuncture; Adjuvant Therapy; Prospective Study; Inflammation

Outcome Measures

Primary Outcomes (1)

• Acupuncture Effects on Inflammation and Menopausal Symptoms in Breast Cancer

  Change in Greene Climacteric Scale evaluated before (T0) and after treatment (ten weeks of treatment (T1) and six-month follow-up (T2)). The scale assigns a rating to the disruption caused by each symptom, ranging from 0 (undisturbed) to 3 (extremely disturbed), across three symptom categories: psychological, physical, and vasomotor. These categories are defined by 21 items, with a total score that ranges from 0 to 63. The mean value of menopausal symptoms experienced over seven consecutive days will be calculated, and changes observed between baseline (T0) and after ten weeks of treatment (T1) and six-month follow-up (T2) will be documented.

  42 months

Secondary Outcomes (2)

• Correlation Between Symptom Improvement and Metabolic Markers in Postmenopausal Women.

  42 months

• Correlation of Biomarkers with Pain Relief and Acupuncture

  42 months

Study Arms (1)

Post menopausal breast cancer patients

Prospective cohort.

Other: Post menopausal breast cancer patients

Interventions

Post menopausal breast cancer patients OTHER

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.

Post menopausal breast cancer patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Disorders of thermoregulation with or without any other symptoms referable to the syndrome menopausal or perimenopausal from at least 6-8 weeks prior study entry.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post menopausal breast cancer patients, it is expected that 60 patients may participate.

You may qualify if:

• Patients with a previous diagnosis of breast cancer.
• Not metastatic disease
• Disorders of thermoregulation with or without any other symptoms referable to the syndrome menopausal or perimenopausal from at least 6-8 weeks prior study entry
• Age 18-65 years
• patients with postmenopausal breast cancer defined as follows:
• bilateral oophorectomy
• age ≥ 60 years
• age ≤ 60 years, who has had at least 12 consecutive months of amenorrhea in the absence of any adjuvant treatment and serum dosage of FSH and E2 in the postmenopausal range (FSH\> 40IU/L and E2 \<10 pg/ml)
• age \<60 years, treated with tamoxifen or aromatase inhibitors and serum dosage of FSH and E2 in the postmenopausal range (FSH\> 40UI/L and E2 \<10 pg/ml)
• patients treated with GhRh analogues for at least 3 months in combination with tamoxifen or aromatase inhibitors for at least 2 months .- Early Postmenopause stage (≤ 5 years) based on Stages of Reproductive Aging Workshop (STRAW) criteria
• BMI within the range of ≥18.5 Kg/m² and less than 24.5 kg/m²
• Number of hot flushes greater than or equal to an average of 6/day in the week and / or average daily score on the climacteric scale of Greene\> of 15 prior to enrolled in study
• ECOG performance status \< or equal to 1
• Not previous diagnosis of inflammatory disorders such as rheumatic, respiratory, dermatologic, no gastroenterologic acute and chronic diseases; none immunological altered condition; no type 1 and 2 diabetes, hypertension, hyperlipidemia; no thyroid diseases or neurodegenerative diseases;
• not women smokers

You may not qualify if:

• Age \< 18 or \> 65 years
• Metastatic breast cancer
• Previous diagnosis of inflammatory disorders such as rheumatic, respiratory, dermatologic, gastroenterologic acute and chronic diseases; any immunological altered condition; type 1 and 2 diabetes; uncontrolled hypertension; hyperlipidemia in treatment; autoimmune thyroid diseases; neurodegenerative diseases;
• smoker;
• Concomitant homeopathy or phytotherapy treatment, corticosteroid, NSAID, antidepressant drugs
• Language or educational barriers to understanding the study purpose

Sponsors & Collaborators

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

Study Sites (1)

Irccs Irst

Meldola, FC, 47014, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh peripheral bloodsamples will be collected at baseline, after 10 weeks and after 6 months.

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes; Inflammation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Anna Fedeli, Dr.

  IRCCS IRST

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 22, 2025
• Study Start: July 2, 2019
• Primary Completion: December 30, 2020
• Study Completion: March 24, 2023
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)