Clinical trial · Observational
Acupuncture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome.
Acupunture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome: A Pilot Study (FLAIR: Flushes, Acupuncture, Inflammation Research)
NCT07137221CI-TRIAL-00093969FLAIRcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post menopausal breast cancer patients | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Post menopausal breast cancer patients
- description
- Prospective cohort.
- interventionNames
- Other: Post menopausal breast cancer patients
Primary outcomes (1)
- measure
- Acupuncture Effects on Inflammation and Menopausal Symptoms in Breast Cancer
- timeFrame
- 42 months
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.