Atrophy;VaginalLEDCANCT03833726
Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment
A study testing Experimental: LED group in people with Atrophy;Vaginal and Breast Cancer, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
Trial summary
Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Atrophy;Vaginal, Breast Cancer
- What is being tested?
- Experimental: LED group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2019to 30 Sep 2023
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 anos
- Pathological proven Breast Cancer diagnosis
- Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition
- Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa)
- Vaginal pH >5,0
Who cannot join
- Hormone replacement less than 6 months
- Diagnosis of vaginal infection
- Difficulty in understanding the proposed instruments
- Patients with chronic neurological degenerative diseases that preclude to be on position
- Metastatic disease
- Any vaginal photodynamic treatment less than 3 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, 40.290-000
About this study
Official title: Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial
Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.
Read the detailed description
The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones and induce functional changes in the vagina cutting in quality of life and impacting sexual function.
This is a randomized, double blind trial in a sample of 74 individuals that will be performed at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH <5.0 and vaginal cytology with predominance of superficial cells).
Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases.
Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them compared with sham procedure, and both groups will perform five sessions of kinesiotherapy sessions.
Maturation vaginal index will be checked before and after all treatment and self- administered questionnaires will be performed before each session with Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7), International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B).
At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction
- Conditions
- Atrophy;Vaginal, Breast Cancer
- Being tested
- Experimental: LED group, Sham Comparator: Control
- Keywords
- Vaginal Atrophy, Breast Cancer, Hormonal Therapy, Photodynamic Therapy, Light Emitting Diode
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: LED groupProcedure or surgery
5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.
Sham Comparator: ControlProcedure or surgery
5 Sessions of 8 minute with device off and heated gel, 7 days apart.
| Study group | Role | What they receive |
|---|---|---|
| LED group | Experimental | Participants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy. Receives: Procedure: Experimental: LED group |
| Control group | Sham comparator | Participants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy. Receives: Procedure: Sham Comparator: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal maturation index
Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Measured: Change from baseline at 3 months
Female Sexual Function Index (FSFI) - Female Version (QS-F)
Measure of quality of sex life. Full Scale Score Range 2-36
Measured: Change from baseline at 3 months
Secondary outcomes (8)
Vaginal pH
pH indicator tape
Measured: Change from baseline at 3 months
Quality of life by FACT B
Functional Assessment of Chronic Therapy- Breast (FACT B) Questionary validated to Portuguese to measure quality of life in breast cancer patients (Total score and Subscale). Graduated 0-128 (lower values means worse quality of life). Physical Wellbeing (PWB) 0-28; Social/Family Wellbeing (SWB) 0-28; Emotional Wellbeing (EWB) 0-24; Funtional Wellbeing (FWB) 0-28; Breast Cancer Subscale (BCS) 0-40. Total Score do not include Arm Subscale (ARM) 0-20
Measured: Change from baseline at 3 months
Urinary symptoms
International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life)
Measured: Change from baseline at 3 months
Visual analog scale
Stratification between 0 and 10 (few symptoms to severe symptoms)
Measured: Change from baseline at 3 months
Female Genital Self-Image Scale - 7 (FGSIS-7)
Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image)
Measured: Change from baseline at 3 months
Likert scale
Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment)
Measured: Change from finished treatment and 3 months after
Sexual Quotients Female Version (QS-F)
Female sex life domain. Scores between 0-100 (higher scores indicate better sex life) Scores between 82-100 score: excellent, 62-80 score: regular, 42-60 score: unfavorable, 22-40 score: regular, 0-20 score: bad
Measured: Change from baseline at 3 months
SF-36
Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start30 Jan 2019
- Primary completion20 Apr 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrophy;VaginalStudies 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
- Parallel groups
- Model description
- The study will be conducted women diagnosed with Genitourinary Syndrome of Menopause treated with kinesiotherapy, divided in two groups: LED treatment or LED Sham.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patríca V Lordelo, PhD, Study chair, Centro de Atenção Pélvica- CAAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833726
- Sponsor's protocol ID
- CAAP CA
- Acronym
- LEDCA
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050.
PubMed 25815692Kyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014 Jun;17(3):252-9. doi: 10.3109/13697137.2013.819327. Epub 2013 Aug 25.
PubMed 23805799Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Maturitas. 2014 Nov;79(3):349-54. doi: 10.1016/j.maturitas.2014.07.013. Epub 2014 Aug 19.
PubMed 25179577Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3.
PubMed 7731384Moreno AC, Sikka SK, Thacker HL. Genitourinary syndrome of menopause in breast cancer survivors:Treatments are available. Cleve Clin J Med. 2018 Oct;85(10):760-766. doi: 10.3949/ccjm.85a.17108.
PubMed 30289755Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2.
PubMed 28154914Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas. 2016 Feb;84:75-80. doi: 10.1016/j.maturitas.2015.11.005. Epub 2015 Nov 12.
PubMed 26617271
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03833726
- Acronym / sponsor ID
- LEDCA / CAAP CA
- Conditions
- Atrophy;Vaginal, Breast Cancer
- Keywords
- Vaginal Atrophy, Breast Cancer, Hormonal Therapy, Photodynamic Therapy, Light Emitting Diode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 7 Feb 2019 (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.
Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.
Detailed description
The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones and induce functional changes in the vagina cutting in quality of life and impacting sexual function.
This is a randomized, double blind trial in a sample of 74 individuals that will be performed at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH <5.0 and vaginal cytology with predominance of superficial cells).
Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases.
Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them compared with sham procedure, and both groups will perform five sessions of kinesiotherapy sessions.
Maturation vaginal index will be checked before and after all treatment and self- administered questionnaires will be performed before each session with Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7), International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B).
At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study will be conducted women diagnosed with Genitourinary Syndrome of Menopause treated with kinesiotherapy, divided in two groups: LED treatment or LED Sham.
| Arm | Type | Receives |
|---|---|---|
| LED group | Experimental | Procedure: Experimental: LED groupParticipants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy. |
| Control group | Sham comparator | Procedure: Sham Comparator: ControlParticipants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 anos
- Pathological proven Breast Cancer diagnosis
- Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition
- Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa)
- Vaginal pH >5,0
Key exclusion criteria (6 listed)
- Hormone replacement less than 6 months
- Diagnosis of vaginal infection
- Difficulty in understanding the proposed instruments
- Patients with chronic neurological degenerative diseases that preclude to be on position
- Metastatic disease
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 |
|---|---|---|
| Experimental: LED group5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart. | Procedure or surgery | LED group |
| Sham Comparator: Control5 Sessions of 8 minute with device off and heated gel, 7 days apart. | Procedure or surgery | Control group |
Primary outcome
Vaginal maturation index
Time frame: Change from baseline at 3 months
Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Female Sexual Function Index (FSFI) - Female Version (QS-F)
Time frame: Change from baseline at 3 months
Measure of quality of sex life. Full Scale Score Range 2-36
8 secondary outcomes
Vaginal pH
Time frame: Change from baseline at 3 months
Quality of life by FACT B
Time frame: Change from baseline at 3 months
Urinary symptoms
Time frame: Change from baseline at 3 months
Visual analog scale
Time frame: Change from baseline at 3 months
Female Genital Self-Image Scale - 7 (FGSIS-7)
Time frame: Change from baseline at 3 months
Likert scale
Time frame: Change from finished treatment and 3 months after
Sexual Quotients Female Version (QS-F)
Time frame: Change from baseline at 3 months
SF-36
Time frame: Change from baseline at 3 months
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 5 Dec 2023.
- Background: PubMed 25815692Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050.
- Background: PubMed 23805799Kyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014 Jun;17(3):252-9. doi: 10.3109/13697137.2013.819327. Epub 2013 Aug 25.
- Background: PubMed 25179577Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Maturitas. 2014 Nov;79(3):349-54. doi: 10.1016/j.maturitas.2014.07.013. Epub 2014 Aug 19.
- Background: PubMed 7731384Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3.
- Background: PubMed 30289755Moreno AC, Sikka SK, Thacker HL. Genitourinary syndrome of menopause in breast cancer survivors:Treatments are available. Cleve Clin J Med. 2018 Oct;85(10):760-766. doi: 10.3949/ccjm.85a.17108.
- Background: PubMed 28154914Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2.
- Background: PubMed 26617271Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas. 2016 Feb;84:75-80. doi: 10.1016/j.maturitas.2015.11.005. Epub 2015 Nov 12.
- NCI Toxicity ScaleLink provided by the sponsor.
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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.
Patríca V Lordelo, PhD study chair
Centro de Atenção Pélvica- CAAP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: LED group in people with Atrophy;Vaginal and Breast Cancer, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
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 5 inclusion and 6 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Vaginal maturation index (time frame: Change from baseline at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833726, which also lists 7 linked publications.
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 5 Dec 2023.