Breast CancerNCT05762042
Comparison of the Efficacy and Tolerability of Femal Versus Placebo
A study testing dietary supplement in people with Breast Cancer and Menopause, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 2 sites in Italy.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Menopause
- What is being tested?
- dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesItaly
- Study dates
- 10 May 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients on SSRI or SNRI antidepressant therapy are excluded
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto Europeo di Oncologia
Milan, 20141
Policlinico Gemelli di Roma
Roma, 00042
About this study
Official title: Comparison of the Efficacy and Tolerability of Femal Versus Placebo in the Treatment of Hot Flashes in Patients With Previous Breast Cancer
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.
Read more
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).
- Conditions
- Breast Cancer, Menopause
- Being tested
- dietary supplement
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Femal | Experimental | Patients in this arm will receive FEMAL (2 cp/die) for three months long Receives: Other: dietary supplement |
| Placebo | Placebo comparator | Patients in this arm will receive PLACEBO (2 cp/die) for three months long Receives: Other: dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start10 May 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762042
- Sponsor's protocol ID
- FEMAL
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Tolerability of Femal Versus Placebo in the Treatment of Hot Flashes in Patients With Previous Breast Cancer
- ClinicalTrials.gov ID
- NCT05762042
- Acronym / sponsor ID
- FEMAL
- Conditions
- Breast Cancer, Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di TorinoUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femal | Experimental | Other: dietary supplementPatients in this arm will receive FEMAL (2 cp/die) for three months long |
| Placebo | Placebo comparator | Other: dietary supplementPatients in this arm will receive PLACEBO (2 cp/die) for three months long |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients on SSRI or SNRI antidepressant therapy are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplementFemal, 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. | Other | Femal, Placebo |
Primary outcome
efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).
Time frame: 3 months
verify efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement in people with Breast Cancer and Menopause, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.