New hope for breast cancer survivors: radiofrequency may ease menopause symptoms without hormones
NCT ID NCT07034976
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitario Ramón y Cajal
RECRUITINGMadrid, Madrid, 28034, Spain
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