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New hope for breast cancer survivors: radiofrequency may ease menopause symptoms without hormones

NCT ID NCT07034976

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a non-surgical radiofrequency device, combined with pelvic floor exercises, can reduce vaginal dryness and other menopause-related symptoms in breast cancer survivors. Fifty women will receive either active or sham radiofrequency once a week for six weeks, plus guided exercises. Researchers will measure symptom changes at the end of treatment and three months later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
non-ablative radiofrequency (Capenergy C500 device) plus pelvic floor muscle training
What this could lead to
If it works, this could offer a non-hormonal option to ease vaginal dryness and discomfort in breast cancer survivors who cannot use estrogen therapy.
What could go wrong
This is a small early trial with only 50 participants, so results may not apply to everyone. The sham group also gets exercise, so the added benefit of radiofrequency may be small or unclear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician. * Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition. * Negative urine culture at baseline. * Moderate to severe vaginal dryness, defined as a score \> 4 on the Numeric Rating Scale (NRS 0-10) Exclusion Criteria: * Age over 75 years. * Current or past diagnosis of any cancer other than breast cancer. * Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months. * Use of local estrogen therapy within the past month. * Active genital infections. * Diagnosis of HIV infection or severe immunosuppression. * Presence of pacemakers, metallic implants, or electromagnetic devices. * Coagulation disorders or current use of anticoagulants. * Pelvic organ prolapse stage \> III (POP-Q classification). * Unexplained abnormal vaginal bleeding. * History of pelvic anti-incontinence surgery, with or without mesh. * Inflammatory dermatoses of the vulva. * Pelvic-floor muscle strength score of 0/5 on the Modified Oxford Scale. * Nickel allergy. * Previous treatment with radiofrequency in the pelvic or genital area.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

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