Patients in adjuvant aromatase inhibitor treatment for breast cancer having serious side effects conserning hot flashes affecting daily life.
Conditions
Interventions
Trade Name: Gabapentin
Product Name: Gabapentin
Pharmaceutical Form: Capsule, hard
Trade Name: Efexor
Product Name: Efexor
Pharmaceutical Form: Capsule, hard
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - At sammenligne eventuelle bivirkninger hos hhv Gabapentin og Venlafaxin . | — |
Countries
Denmark
Outcome results
None listed