Status:
COMPLETED
Acupuncture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome.
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
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 wit...
Detailed Description
In healthy postmenopausal women, hot flashes (HF) have been associated with systemic inflammation. Several studies suggest that acupuncture (ACU) is effective in improving menopausal HF symptoms, bot...
Eligibility Criteria
Inclusion
- 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
- not concomitant homeopaty or phytotherapy treatment, corticosteroid, NSAID, antidepressant drugs
- written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07137221
Start Date
July 2 2019
End Date
March 24 2023
Last Update
August 22 2025
Active Locations (1)
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1
Irccs Irst
Meldola, FC, Italy, 47014