- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00209001
Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.
Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably.
Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the "change of life"). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University Winship Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Female
- 18 years of age or older
- History of breast cancer who have received hormonal therapy
- Personal history of hot flashes
- Patients will be accepted if receiving therapy with traditional allopathic medicines if their hot flashes have persisted after two months
Exclusion Criteria:
- Receiving therapy with traditional allopathic medicines for hot flashes
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Observation
|
|
Aktiv komparator: Akupunktur
|
Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
|
Sham-komparator: Sham acupuncture therapy
|
Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Define efficacy of acupuncture to points of the enhanced Ming Men technique for relief of hot flashes after hormonal therapy for breast cancer.
Tidsramme: weekly evaluation up to 9 weeks
|
weekly evaluation up to 9 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Peter Johnstone, MD, Emory University Winship Cancer Institute
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0533-2003
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