Breast Cancer FemaleSEXCHECKNCT06458764
Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study
An observational study of Breast Cancer Female and Sexual Dysfunction, run by Candiolo Cancer Institute - IRCCS at 1 site in Italy.
Trial summary
Primary objectives: To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy. To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Breast Cancer Female, Sexual Dysfunction, Premenopausal Breast Cancer
- What is being tested?
- Questionnaire
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 1 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged ≥18 and ≤ 55 who underwent surgery for early stage breast cancer, taking endocrine therapy for at least 3 months
Who may be able to join
- women aged ≥18 and ≤ 55
- who underwent surgery for early stage breast cancer
- taking endocrine therapy for at least 3 months
- providing an informed consent and completing the study questionnaires.
Who cannot join
- withdrawal of the informed consent, at any time
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Candiolo Cancer Center
Torino, TO, 10060
Giada Pozzi, MD, +390119933017, giada.pozzi@ircc.it
About this study
Official title: SEXCHECK - Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study
Primary objectives:
- To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
- To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.
Secondary objectives:
- To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
- Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.
- Being tested
- Questionnaire
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
none, it's a incidence-prevalence study
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Questionnaire | |
| Controls | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Dysfunction (SD) incidence
To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
Measured: 6 months
SD-related distress
To detect the presence of SD-related distress (physiological parameter) in the population, as a determining factor in the maintenance of a good quality of life.
Measured: 6 months
Secondary outcomes (2)
SD characteristics
To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
Measured: 6 months
Collect baseline data
Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 May 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Candiolo Cancer Institute - IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giada Pozzi, Candiolo Cancer Institute - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458764
- Sponsor's protocol ID
- 71/2023
- Acronym
- SEXCHECK
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carmen A, Anne O, Monika S, Daniel E, Johannes G, Verena M, Michael H, Christine B. Does the toxicity of endocrine therapy persist into long-term survivorship?: Patient-reported outcome results from a follow-up study beyond a 10-year-survival. Breast Cancer Res Treat. 2023 Apr;198(3):475-485. doi: 10.1007/s10549-022-06808-9. Epub 2022 Nov 23.
PubMed 36418518Qi A, Li Y, Sun H, Jiao H, Liu Y, Chen Y. Incidence and risk factors of sexual dysfunction in young breast cancer survivors. Ann Palliat Med. 2021 Apr;10(4):4428-4434. doi: 10.21037/apm-21-352.
PubMed 33966393McCool ME, Zuelke A, Theurich MA, Knuettel H, Ricci C, Apfelbacher C. Prevalence of Female Sexual Dysfunction Among Premenopausal Women: A Systematic Review and Meta-Analysis of Observational Studies. Sex Med Rev. 2016 Jul;4(3):197-212. doi: 10.1016/j.sxmr.2016.03.002. Epub 2016 Apr 19.
PubMed 27871953Jing L, Zhang C, Li W, Jin F, Wang A. Incidence and severity of sexual dysfunction among women with breast cancer: a meta-analysis based on female sexual function index. Support Care Cancer. 2019 Apr;27(4):1171-1180. doi: 10.1007/s00520-019-04667-7. Epub 2019 Feb 2.
PubMed 30712099Seav SM, Dominick SA, Stepanyuk B, Gorman JR, Chingos DT, Ehren JL, Krychman ML, Su HI. Management of sexual dysfunction in breast cancer survivors: a systematic review. Womens Midlife Health. 2015 Nov 2;1:9. doi: 10.1186/s40695-015-0009-4. eCollection 2015.
PubMed 30766696Du H, Chen C, Yuan F, Hu A, Han J. Correlation analysis of body image level and female sexual dysfunction in young patients with postoperative breast cancer. J Cancer Res Ther. 2022 Sep;18(5):1360-1371. doi: 10.4103/jcrt.jcrt_629_21.
PubMed 36204884Sousa Rodrigues Guedes T, Barbosa Otoni Goncalves Guedes M, de Castro Santana R, Costa da Silva JF, Almeida Gomes Dantas A, Ochandorena-Acha M, Terradas-Monllor M, Jerez-Roig J, Bezerra de Souza DL. Sexual Dysfunction in Women with Cancer: A Systematic Review of Longitudinal Studies. Int J Environ Res Public Health. 2022 Sep 21;19(19):11921. doi: 10.3390/ijerph191911921.
PubMed 36231221Taylor CE, Meisel JL. Management of Breast Cancer Therapy-Related Sexual Dysfunction. Oncology (Williston Park). 2017 Oct 15;31(10):726-9.
PubMed 29083465Gorman JR, Lyons KS, Harvey SM, Acquati C, Salsman JM, Kashy DA, Drizin JH, Smith E, Flexner LM, Hayes-Lattin B, Reese JB. Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples. Trials. 2022 Sep 2;23(1):730. doi: 10.1186/s13063-022-06665-3.
PubMed 36056413Advani P, Brewster AM, Baum GP, Schover LR. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy. J Cancer Surviv. 2017 Aug;11(4):477-485. doi: 10.1007/s11764-017-0606-3. Epub 2017 Feb 22.
PubMed 28229275Ljungman L, Ahlgren J, Petersson LM, Flynn KE, Weinfurt K, Gorman JR, Wettergren L, Lampic C. Sexual dysfunction and reproductive concerns in young women with breast cancer: Type, prevalence, and predictors of problems. Psychooncology. 2018 Dec;27(12):2770-2777. doi: 10.1002/pon.4886. Epub 2018 Sep 27.
PubMed 30203884Maiorino MI, Chiodini P, Bellastella G, Giugliano D, Esposito K. Sexual dysfunction in women with cancer: a systematic review with meta-analysis of studies using the Female Sexual Function Index. Endocrine. 2016 Nov;54(2):329-341. doi: 10.1007/s12020-015-0812-6. Epub 2015 Dec 7.
PubMed 26643312Fogh M, Hojgaard A, Rotbol CB, Jensen AB. The majority of Danish breast cancer survivors on adjuvant endocrine therapy have clinically relevant sexual dysfunction: a cross-sectional study. Acta Oncol. 2021 Jan;60(1):61-68. doi: 10.1080/0284186X.2020.1813326. Epub 2020 Sep 1.
PubMed 32869712Gandhi C, Butler E, Pesek S, Kwait R, Edmonson D, Raker C, Clark MA, Stuckey A, Gass J. Sexual Dysfunction in Breast Cancer Survivors: Is it Surgical Modality or Adjuvant Therapy? Am J Clin Oncol. 2019 Jun;42(6):500-506. doi: 10.1097/COC.0000000000000552.
PubMed 31094713Cobo-Cuenca AI, Martin-Espinosa NM, Sampietro-Crespo A, Rodriguez-Borrego MA, Carmona-Torres JM. Sexual dysfunction in Spanish women with breast cancer. PLoS One. 2018 Aug 31;13(8):e0203151. doi: 10.1371/journal.pone.0203151. eCollection 2018.
PubMed 30169506
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEXCHECK - Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06458764
- Acronym / sponsor ID
- SEXCHECK / 71/2023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Candiolo Cancer Institute - IRCCSUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Jun 2024 (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.
Primary objectives:
- To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
- To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.
Secondary objectives:
- To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
- Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Questionnaire |
| Controls | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged ≥18 and ≤ 55 who underwent surgery for early stage breast cancer, taking endocrine therapy for at least 3 months
Key inclusion criteria (4 listed)
- women aged ≥18 and ≤ 55
- who underwent surgery for early stage breast cancer
- taking endocrine therapy for at least 3 months
- providing an informed consent and completing the study questionnaires.
Key exclusion criteria (1 listed)
- withdrawal of the informed consent, at any time
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 |
|---|---|---|
| Questionnairenone, it's a incidence-prevalence study | Other | Controls, Patients |
Primary outcome
Sexual Dysfunction (SD) incidence
Time frame: 6 months
To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
SD-related distress
Time frame: 6 months
To detect the presence of SD-related distress (physiological parameter) in the population, as a determining factor in the maintenance of a good quality of life.
2 secondary outcomes
SD characteristics
Time frame: 6 months
Collect baseline data
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 36418518Carmen A, Anne O, Monika S, Daniel E, Johannes G, Verena M, Michael H, Christine B. Does the toxicity of endocrine therapy persist into long-term survivorship?: Patient-reported outcome results from a follow-up study beyond a 10-year-survival. Breast Cancer Res Treat. 2023 Apr;198(3):475-485. doi: 10.1007/s10549-022-06808-9. Epub 2022 Nov 23.
- Background: PubMed 33966393Qi A, Li Y, Sun H, Jiao H, Liu Y, Chen Y. Incidence and risk factors of sexual dysfunction in young breast cancer survivors. Ann Palliat Med. 2021 Apr;10(4):4428-4434. doi: 10.21037/apm-21-352.
- Results publication: PubMed 27871953McCool ME, Zuelke A, Theurich MA, Knuettel H, Ricci C, Apfelbacher C. Prevalence of Female Sexual Dysfunction Among Premenopausal Women: A Systematic Review and Meta-Analysis of Observational Studies. Sex Med Rev. 2016 Jul;4(3):197-212. doi: 10.1016/j.sxmr.2016.03.002. Epub 2016 Apr 19.
- Results publication: PubMed 30712099Jing L, Zhang C, Li W, Jin F, Wang A. Incidence and severity of sexual dysfunction among women with breast cancer: a meta-analysis based on female sexual function index. Support Care Cancer. 2019 Apr;27(4):1171-1180. doi: 10.1007/s00520-019-04667-7. Epub 2019 Feb 2.
- Results publication: PubMed 30766696Seav SM, Dominick SA, Stepanyuk B, Gorman JR, Chingos DT, Ehren JL, Krychman ML, Su HI. Management of sexual dysfunction in breast cancer survivors: a systematic review. Womens Midlife Health. 2015 Nov 2;1:9. doi: 10.1186/s40695-015-0009-4. eCollection 2015.
- Results publication: PubMed 36204884Du H, Chen C, Yuan F, Hu A, Han J. Correlation analysis of body image level and female sexual dysfunction in young patients with postoperative breast cancer. J Cancer Res Ther. 2022 Sep;18(5):1360-1371. doi: 10.4103/jcrt.jcrt_629_21.
- Results publication: PubMed 36231221Sousa Rodrigues Guedes T, Barbosa Otoni Goncalves Guedes M, de Castro Santana R, Costa da Silva JF, Almeida Gomes Dantas A, Ochandorena-Acha M, Terradas-Monllor M, Jerez-Roig J, Bezerra de Souza DL. Sexual Dysfunction in Women with Cancer: A Systematic Review of Longitudinal Studies. Int J Environ Res Public Health. 2022 Sep 21;19(19):11921. doi: 10.3390/ijerph191911921.
- Results publication: PubMed 29083465Taylor CE, Meisel JL. Management of Breast Cancer Therapy-Related Sexual Dysfunction. Oncology (Williston Park). 2017 Oct 15;31(10):726-9.
- Results publication: PubMed 36056413Gorman JR, Lyons KS, Harvey SM, Acquati C, Salsman JM, Kashy DA, Drizin JH, Smith E, Flexner LM, Hayes-Lattin B, Reese JB. Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples. Trials. 2022 Sep 2;23(1):730. doi: 10.1186/s13063-022-06665-3.
- Results publication: PubMed 28229275Advani P, Brewster AM, Baum GP, Schover LR. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy. J Cancer Surviv. 2017 Aug;11(4):477-485. doi: 10.1007/s11764-017-0606-3. Epub 2017 Feb 22.
- Results publication: PubMed 30203884Ljungman L, Ahlgren J, Petersson LM, Flynn KE, Weinfurt K, Gorman JR, Wettergren L, Lampic C. Sexual dysfunction and reproductive concerns in young women with breast cancer: Type, prevalence, and predictors of problems. Psychooncology. 2018 Dec;27(12):2770-2777. doi: 10.1002/pon.4886. Epub 2018 Sep 27.
- Results publication: PubMed 26643312Maiorino MI, Chiodini P, Bellastella G, Giugliano D, Esposito K. Sexual dysfunction in women with cancer: a systematic review with meta-analysis of studies using the Female Sexual Function Index. Endocrine. 2016 Nov;54(2):329-341. doi: 10.1007/s12020-015-0812-6. Epub 2015 Dec 7.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Sexual Dysfunction, run by Candiolo Cancer Institute - IRCCS at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 24 Jun 2025. 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Dysfunction (SD) incidence (time frame: 6 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 NCT06458764, which also lists 16 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 24 Jun 2025.