Et prospektivt randomiseret fase II studie til evaluering af Gabapentin og Venlafaxin´s virkning mod hedestigninger hos kvinder opereret for brystkræft og iantihormonbehandling i form af aromatasehæmmer
Phase 1
- Conditions
- Patients in adjuvant aromatase inhibitor treatment for breast cancer having serious side effects conserning hot flashes affecting daily life.
- Registration Number
- EUCTR2007-004791-39-DK
- Lead Sponsor
- Vejle Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 68
Inclusion Criteria
-Kvinder i adjuverende antihormonbehandling med arometasehæmmer igennem minimum 4 uger.
-Minimum 4 stk. grad 3 hedestigninger om ugen og mindst 14 hedestigninger uanset grad om ugen
-Informeret samtykke.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Hypertension, hypotension
-I behandling med antihypertensiva
-Kardiel lidelse
-I behandling med antidepressiva
-I behandling med anden non-hormonel behandling for hedestigninger incl. akupunktur
-Neurologiske symptomer
-Gravide eller ammende
-Nyreinsuifficiens
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare effect of Gabapentin to Efexor in the treatment of hot Flashes.;Secondary Objective: To compare side effect of the two treatment modalities;Primary end point(s): -Undersøgelsen har til formål at sammenligne Gabapentin versus Venlafaxin´s virkning mod hedestigninger hos kvinder opereret for brystkræft og i aromatasehæmmerbehandling. <br><br>-At sammenligne eventuelle bivirkninger hos hhv Gabapentin og Venlafaxin .<br><br><br>
- Secondary Outcome Measures
Name Time Method