Proof-of-concept study on treating cognitive side-effects of Tamoxifen with guanfacine in postmenopausal women with E2/Pg receptor-positive breast cancer.

Proof-of-concept study on treating cognitive side-effects of Tamoxifen with guanfacine in postmenopausal women with E2/Pg receptor-positive breast cancer. - A study on the effect of guanfacine of the side effects of Tamoxifen

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43176

Enrollment

Registered

2016-03-22

Start date

2016-03-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

attentional deficit Memory loss

Interventions

Guanfacine, 0.03-047. mg/kg (2 or 3 mg) once daily, for four consecutive weeks, and placebo during four weeks. Note that all participants are on stable 20 mg daily Tamoxifen treatment, on inclusion,

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • treated with adjuvant tamoxifen therapy for ER receptor-positive Breast Cancer • on tamoxifen treatment for 3-18 months, 20 mg stable dosing for at least a month • postmenopausal • subjective complaints of cognitive side effects • weight between 50 and 90 kg • 20

Exclusion criteria

Exclusion criteria: • prior exposure to chemotherapy • diagnosis of prior or existing cardiovascular, neurological or psychiatric disorder that may influence sensitivity to guanfacine or study endpoint(s) • contraindications for guanfacine (hypotension, bradycardia, syncope, extended QT interval) • (prior) diagnosis of ADHD • use of clonidine or other anti-hypertensive agents • use of drugs with a strong influence on CYP2D6, CYP3A4/5 (e.g., ketoconazole, carbamazepine) • use of SSRIs and other antidepressants

Design outcomes

Primary

Measure	Time frame
Change in cognitive functions from placebo to guanfacine condition. Cognitive functions are assessed by standardized neuropsychological tasks and include executive functions, attention, memory, and processing speed.	—

Secondary

Measure	Time frame
Change in depression / anxiety and physical side-effects from placebo to guanfacine condition. Affect is measured by a standardized questionnaire (POMS). Physical side-effects recorded include those reported for tamoxifen and guanfacine. The most commonly reported side effects for tamoxifen (hot flushes, vaginal bleeding and secretions, pruritus vulvae) and guanfacine (sedation, headache, abdominal pains, signs and symptoms related to changes in blood pressure) are explicitly asked about during a weekly structured telephone interview.	—

Measure

Time frame

Change in depression / anxiety and physical side-effects from placebo to guanfacine condition. Affect is measured by a standardized questionnaire (POMS). Physical side-effects recorded include those reported for tamoxifen and guanfacine. The most commonly reported side effects for tamoxifen (hot flushes, vaginal bleeding and secretions, pruritus vulvae) and guanfacine (sedation, headache, abdominal pains, signs and symptoms related to changes in blood pressure) are explicitly asked about during a weekly structured telephone interview.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)