Comparison of the Efficacy and Tolerability of Femal Versus Placebo

Breast Cancer Clinical Trial

Official title:

Comparison of the Efficacy and Tolerability of Femal Versus Placebo in the Treatment of Hot Flashes in Patients With Previous Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762042
• Other study ID #: FEMAL
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2023
• Source: Azienda Ospedaliera Ordine Mauriziano di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms.

Patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included.

Patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry.

Patients on SSRI or SNRI antidepressant therapy are excluded. Eligible patients will be randomly assigned to either Femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with a history of breast cancer, in spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flushes per week).

Patients who are on tamoxifen or aromatase anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry

Exclusion Criteria:

• Patients on SSRI or SNRI antidepressant therapy are excluded

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Menopause

Intervention

Other:
• dietary supplement
Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms. The mechanism of action of Femal has not yet been fully clarified: Femal inhibits the absorption of serotonin in a dose-dependent manner and has strong antioxidant properties. The lack of estrogenic effects would make this preparation of particular interest for women with a previous hormone-dependent neoplasia who undergo an early iatrogenic menopause. Femal tablets contain a standardized formulation containing: GC Fem pollen extract 40 mg, PI82 pollen / pistil extract 120 mg, vitamin E 5 mg, amino acids 14 mg per tablet. The dosage is 2 tablets a day orally.

Locations

Country	Name	City	State
Italy	Istituto Europeo di Oncologia	Milano
Italy	Policlinico Gemelli di Roma	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Ordine Mauriziano di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).	verify efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).	3 months