Breast CancerFLAIRNCT07137221
Acupuncture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome.
An observational study of Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Post menopausal breast cancer patients
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2019to 24 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Post menopausal breast cancer patients, it is expected that 60 patients may participate.
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupunture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome: A Pilot Study (FLAIR: Flushes, Acupuncture, Inflammation Research)
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.
Read the 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, both in healthy women and in patients with breast cancer. The effectiveness of ACU appears to be independent of changes in estradiol, FSH, and LH levels; however, the precise mechanisms through which ACU alleviates HF have not yet been clearly documented.
Various studies indicate that menopause may trigger an increase in pro-inflammatory cytokines, likely due to the decline in sex hormone levels. Moreover, the elevated levels of pro-inflammatory factors during menopause may be linked to later health events, such as the development of osteoporosis and atherosclerosis.
The literature highlights a connection between increased activity of pro-inflammatory cytokines-particularly IL-6-and postmenopausal bone loss, involving the RANK and Osteoprotegerin (OPG) pathways.
The severity of HF is also significantly associated with the HOMA index and other markers of insulin resistance. This suggests a possible correlation between the severity of postmenopausal HF and the risk of cardiovascular disease, including in breast cancer patients.
The primary objective of this study is to investigate the biochemical mechanisms underlying the effectiveness of acupuncture in alleviating hot flashes and other climacteric symptoms in postmenopausal women with breast cancer. Specifically, the study aims to determine whether the clinical benefits observed with acupuncture treatment are associated with measurable changes in inflammatory dysregulation in this patient population.
In addition to the primary objective, the study includes several secondary aims. These involve evaluating the relationship between the improvement of postmenopausal symptoms and various biological markers, including indicators of bone loss, insulin resistance, hormone levels, and lipid profile. Furthermore, the study seeks to explore the correlation between circulating biomarkers and pain relief, as measured through validated instruments such as the EQ-5D-5L and BPI questionnaires, in the context of acupuncture treatment.
It is anticipated that approximately 60 patients will participate, and the study will last a total of 42 months.
- Conditions
- Breast Cancer
- Being tested
- Post menopausal breast cancer patients
- Keywords
- Observational, postmonopausal, breast cancer, Hot Flashes, Acupuncture, Adjuvant Therapy, Prospective Study, Inflammation
- Medical subject headings
- Breast Neoplasms, Hot Flashes, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post menopausal breast cancer patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post menopausal breast cancer patients | Prospective cohort. Receives: Other: Post menopausal breast cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 months
Secondary outcomes (2)
Correlation Between Symptom Improvement and Metabolic Markers in Postmenopausal Women.
Changes in hot flash intensity, inflammatory cytokine levels (IFN-γ, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-22, TNF-α), menopausal symptoms, markers of insulin resistance (fasting glucose, insulin, glycated hemoglobin), lipid profile (total cholesterol, HDL, LDL, triglycerides), bone density (calcium, vitamin D, parathyroid hormone, C-telopeptide), hormonal levels (FSH, LH, estradiol), quality of life (EQ-5D-5L questionnaire) and pain level (Brief Pain Inventory scale) evaluated before and after treatment.
Measured: 42 months
Correlation of Biomarkers with Pain Relief and Acupuncture
Circulating markers with pain relief (EQ-5D-5L and BPI) questionnaires and acupuncture procedure.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start2 Jul 2019
- Primary completion30 Dec 2020
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Fedeli, Dr., Study director, IRCCS IRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137221
- Sponsor's protocol ID
- IRSTB104
- Acronym
- FLAIR
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupunture And Inflammatory Status In Breast Cancer Patients With Climateric Syndrome: A Pilot Study (FLAIR: Flushes, Acupuncture, Inflammation Research)
- ClinicalTrials.gov ID
- NCT07137221
- Acronym / sponsor ID
- FLAIR / IRSTB104
- Conditions
- Breast Cancer
- Keywords
- Observational, postmonopausal, breast cancer, Hot Flashes, Acupuncture, Adjuvant Therapy, Prospective Study, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, both in healthy women and in patients with breast cancer. The effectiveness of ACU appears to be independent of changes in estradiol, FSH, and LH levels; however, the precise mechanisms through which ACU alleviates HF have not yet been clearly documented.
Various studies indicate that menopause may trigger an increase in pro-inflammatory cytokines, likely due to the decline in sex hormone levels. Moreover, the elevated levels of pro-inflammatory factors during menopause may be linked to later health events, such as the development of osteoporosis and atherosclerosis.
The literature highlights a connection between increased activity of pro-inflammatory cytokines-particularly IL-6-and postmenopausal bone loss, involving the RANK and Osteoprotegerin (OPG) pathways.
The severity of HF is also significantly associated with the HOMA index and other markers of insulin resistance. This suggests a possible correlation between the severity of postmenopausal HF and the risk of cardiovascular disease, including in breast cancer patients.
The primary objective of this study is to investigate the biochemical mechanisms underlying the effectiveness of acupuncture in alleviating hot flashes and other climacteric symptoms in postmenopausal women with breast cancer. Specifically, the study aims to determine whether the clinical benefits observed with acupuncture treatment are associated with measurable changes in inflammatory dysregulation in this patient population.
In addition to the primary objective, the study includes several secondary aims. These involve evaluating the relationship between the improvement of postmenopausal symptoms and various biological markers, including indicators of bone loss, insulin resistance, hormone levels, and lipid profile. Furthermore, the study seeks to explore the correlation between circulating biomarkers and pain relief, as measured through validated instruments such as the EQ-5D-5L and BPI questionnaires, in the context of acupuncture treatment.
It is anticipated that approximately 60 patients will participate, and the study will last a total of 42 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post menopausal breast cancer patients | – | Other: Post menopausal breast cancer patientsProspective cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post menopausal breast cancer patients, it is expected that 60 patients may participate.
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post menopausal breast cancer patientsAll 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. | Other | Post menopausal breast cancer patients |
Primary outcome
Acupuncture Effects on Inflammation and Menopausal Symptoms in Breast Cancer
Time frame: 42 months
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.
2 secondary outcomes
Correlation Between Symptom Improvement and Metabolic Markers in Postmenopausal Women.
Time frame: 42 months
Correlation of Biomarkers with Pain Relief and Acupuncture
Time frame: 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Fedeli, Dr. study director
IRCCS IRST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acupuncture Effects on Inflammation and Menopausal Symptoms in Breast Cancer (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.