ClinicalTrials.gg
RecruitingNCT06458764SEXCHECKUpdated Jun 24, 2025

Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study

An observational study in Breast Cancer Female, Sexual Dysfunction and Premenopausal Breast Cancer, sponsored by Candiolo Cancer Institute - IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Candiolo Cancer Institute - IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

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.
02

Conditions studied

  • Breast Cancer Female
  • Sexual Dysfunction
  • Premenopausal Breast Cancer
03

In context

Sexual Dysfunction, Physiological

385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.

This study's planned enrollment of 150 is below the median of 176 across 113 observational studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Candiolo Cancer Institute - IRCCS is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women aged ≥18 and ≤ 55 who underwent surgery for early stage breast cancer, taking endocrine therapy for at least 3 months

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women aged ≥18 and ≤ 55
  • who underwent surgery for early stage breast cancer
  • taking endocrine therapy for at least 3 months
  • providing an and completing the study questionnaires.

Exclusion criteria

Exclusion Criteria:

  • withdrawal of the , at any time
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Patients

    Other: Questionnaire

  • Controls

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    none, it's a incidence-prevalence study

06

What researchers measure

Primary outcomes

  1. Sexual Dysfunction (SD) incidence

    To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. SD characteristics

    To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.

    Time frame: 6 months

  2. Collect baseline data

    Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • McCool 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 27871953 ↗
  • Jing 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 30712099 ↗
  • Seav 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 30766696 ↗
  • Du 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 36204884 ↗
  • 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 36418518 ↗
  • Sousa 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 36231221 ↗
  • Qi 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 33966393 ↗
  • Taylor CE, Meisel JL. Management of Breast Cancer Therapy-Related Sexual Dysfunction. Oncology (Williston Park). 2017 Oct 15;31(10):726-9. PubMed 29083465 ↗
  • Gorman 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 36056413 ↗
  • Advani 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 28229275 ↗
  • Ljungman 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 30203884 ↗
  • Maiorino 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 26643312 ↗
  • Fogh 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 32869712 ↗
  • Gandhi 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 31094713 ↗
  • Cobo-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 ↗
  • Carpenter JS, Reed SD, Guthrie KA, Larson JC, Newton KM, Lau RJ, Learman LA, Shifren JL. Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis. Sex Med. 2015 Mar;3(1):7-13. doi: 10.1002/sm2.53. PubMed 25844170 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Dec 2025, 31 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2024
First posted
Jun 14, 2024
StartActual
May 1, 2023
Primary completionEst.
Dec 1, 2025
CompletionEst.
Dec 1, 2025
Last update
Jun 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06458764
Lead sponsor
Candiolo Cancer Institute - IRCCS
Responsible party
Giada Pozzi (MD, Candiolo Cancer Institute - IRCCS) — Principal investigator
First posted
Jun 14, 2024
Start date
May 1, 2023
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jun 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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