Climacteric SyndromePhase 4AcCliMaTNCT01275807
Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer
A Phase 4 study testing acupuncture and self care in people with Climacteric Syndrome, run by Azienda Usl di Bologna at 4 sites in Italy.
Trial summary
The purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Climacteric Syndrome
- What is being tested?
- acupuncture and self care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 4 sitesItaly
- Study dates
- Mar 2010to Sep 2015
- Phase
- Phase 4
- 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
Who may be able to join
- breast cancer
- thermoregulation symptoms from at least 6-8 weeks - at least 6 hot flushes a day
- climateric simptoms
- age from 18 to 65 years
- spontaneous or caused by chemotherapy amenorrea
- hormone therapy for breast cancer
Show all 10Show fewer
- Green climateric scale score = or > of 15
- performance status Eastern Cooperative Oncology Group (ECOG) < or = to 1
- the patient agrees to follow physical exercice
- diet and self-help groups
Who cannot join
- Hormone substitutive Therapy (TOS) during the last month
- other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy)
- chemotherapy or radiotherapy
- patients who refuses acupuncture
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori
Bologna, Bologna, 40100
Oncologic Medicine, Carpi Hospital
Carpi, Modena
Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio,
Piacenza
U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia
Reggio Emilia
About this study
Official title: Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer
The purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care).
Read the detailed description
The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: Greene climacteric scale score, quality of life (MenQol italian version), overall improvement in climacteric syndrome, adverse effects from treatment.
- Conditions
- Climacteric Syndrome
- Being tested
- acupuncture, self care
- Keywords
- climacteric, climacteric syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Also called chinese traditional medicine
10 sessions of acupuncture
self careOther
Also called self help
physical exercice, diet, self help groups, psychological support
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | 10 acupuncture sessions Receives: Device: acupuncture |
| self care | Active comparator | psychological support, phisical exercice, diet, self care groups Receives: Other: self care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greene climacteric scale
Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.
Measured: baseline ( 14 days before randomization) , between the 5th and 6th session af acupunture(only for experimental arm) at 14 weeks after randomization and at 3 and at 6 month after randomization for both arms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Climacteric SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- Regione Emilia-Romagna
- Responsible party
- Sponsor
- Investigators
- grazia lesi, MD, Study director, Bologna Local Health District - Azienda Usl di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275807
- Sponsor's protocol ID
- DGR-2025/2008-Lesi
- Acronym
- AcCliMaT
- Status last verified
- Sep 2015
- First submitted
- 30 Dec 2010
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta P, Sturdee DW, Palin SL, Majumder K, Fear R, Marshall T, Paterson I. Menopausal symptoms in women treated for breast cancer: the prevalence and severity of symptoms and their perceived effects on quality of life. Climacteric. 2006 Feb;9(1):49-58. doi: 10.1080/13697130500487224.
PubMed 16428125Lesi G, Razzini G, Musti MA, Stivanello E, Petrucci C, Benedetti B, Rondini E, Ligabue MB, Scaltriti L, Botti A, Artioli F, Mancuso P, Cardini F, Pandolfi P. Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). J Clin Oncol. 2016 May 20;34(15):1795-802. doi: 10.1200/JCO.2015.63.2893. Epub 2016 Mar 28.
PubMed 27022113
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as an Integrated Intervention for the Control of Symptoms of Climacteric Syndrome in Patients Affected by Breast Cancer
- ClinicalTrials.gov ID
- NCT01275807
- Acronym / sponsor ID
- AcCliMaT / DGR-2025/2008-Lesi
- Conditions
- Climacteric Syndrome
- Keywords
- climacteric, climacteric syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- Regione Emilia-Romagna
- Study start
- Mar 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Jan 2011 (estimated)
- 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.
The purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care).
Detailed description
The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: Greene climacteric scale score, quality of life (MenQol italian version), overall improvement in climacteric syndrome, adverse effects from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Device: acupuncture10 acupuncture sessions |
| self care | Active comparator | Other: self carepsychological support, phisical exercice, diet, self care groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- breast cancer
- thermoregulation symptoms from at least 6-8 weeks - at least 6 hot flushes a day
- climateric simptoms
- age from 18 to 65 years
- spontaneous or caused by chemotherapy amenorrea
Key exclusion criteria (4 listed)
- Hormone substitutive Therapy (TOS) during the last month
- other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy)
- chemotherapy or radiotherapy
- patients who refuses acupuncture
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 |
|---|---|---|
| acupunctureAlso: chinese traditional medicine10 sessions of acupuncture | Device | acupuncture |
| self careAlso: self helpphysical exercice, diet, self help groups, psychological support | Other | self care |
Primary outcome
Greene climacteric scale
Time frame: baseline ( 14 days before randomization) , between the 5th and 6th session af acupunture(only for experimental arm) at 14 weeks after randomization and at 3 and at 6 month after randomization for both arms.
Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes.
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 Sep 2015.
- Background: PubMed 16428125Gupta P, Sturdee DW, Palin SL, Majumder K, Fear R, Marshall T, Paterson I. Menopausal symptoms in women treated for breast cancer: the prevalence and severity of symptoms and their perceived effects on quality of life. Climacteric. 2006 Feb;9(1):49-58. doi: 10.1080/13697130500487224.
- Derived from this study: PubMed 27022113Lesi G, Razzini G, Musti MA, Stivanello E, Petrucci C, Benedetti B, Rondini E, Ligabue MB, Scaltriti L, Botti A, Artioli F, Mancuso P, Cardini F, Pandolfi P. Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). J Clin Oncol. 2016 May 20;34(15):1795-802. doi: 10.1200/JCO.2015.63.2893. Epub 2016 Mar 28.
Related trials for Climacteric Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
Coronary Artery Disease (CAD), Menopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Menopause Syndrome, Sleep Disturbance
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases
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.
grazia lesi, MD study director
Bologna Local Health District - Azienda Usl di Bologna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acupuncture and self care in people with Climacteric Syndrome, run by Azienda Usl di Bologna at 4 sites 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 10 inclusion and 4 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Greene climacteric scale (time frame: baseline ( 14 days before randomization) , between the 5th and 6th session af acupunture(only for experimental arm) at 14 weeks after randomization and at 3 and at 6 month after randomization for both arms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275807, which also lists 2 linked publications.
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 Sep 2015.