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| Name | Class |
|---|---|
| Regione Emilia-Romagna | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | 10 acupuncture sessions |
|
| self care | Active Comparator | psychological support, phisical exercice, diet, self care groups |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | 10 sessions of acupuncture |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Greene climacteric scale | Greene's score as measure for severity of menopausal symptoms. Change in the number of hot flashes. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| grazia lesi, MD | Bologna Local Health District - Azienda Usl di Bologna | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unità operativa (U.O.) salute donna infanzia e adolescenza e Unità operativa Consultori | Bologna | Bologna | 40100 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16428125 | Background | 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. | |
| 27022113 | Derived | Lesi 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. |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D008516 | Medicine, Chinese Traditional |
| D012648 | Self Care |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
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| self care | Other | physical exercice, diet, self help groups, psychological support |
|
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| Oncologic Medicine, Carpi Hospital |
| Carpi |
| Modena |
| Italy |
| Dipartimento Anestesia, rianimazione, terapia del dolore e comparto operatorio, | Piacenza | Italy |
| U.O. Medicina Oncologica - Ospedale Santa Maria Nuova Reggio Emilia | Reggio Emilia | Italy |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |