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

Breast Cancer Female Clinical Trial

— SEXCHECK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458764
• Other study ID #: 71/2023
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Candiolo Cancer Institute - IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 informed consent and completing the study questionnaires.

Exclusion Criteria:

• withdrawal of the informed consent, at any time

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Premenopausal Breast Cancer
• Sexual Dysfunction

Intervention

Other:
• Questionnaire
none, it's a incidence-prevalence study

Locations

Country	Name	City	State
Italy	IRCCS Candiolo Cancer Center	Torino	TO

Sponsors (1)

Lead Sponsor	Collaborator
Candiolo Cancer Institute - IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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/s11764-017-06 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.2020.18133 — View Citation

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. — View Citation

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 se — View Citation

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 — View Citation

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):277 — View Citation

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- — View Citation

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.sxm — View Citation

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. — View Citation

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 20 — View Citation

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 Re — View Citation

Taylor CE, Meisel JL. Management of Breast Cancer Therapy-Related Sexual Dysfunction. Oncology (Williston Park). 2017 Oct 15;31(10):726-9. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Dysfunction (SD) incidence	To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.	6 months
Primary	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.	6 months
Secondary	SD characteristics	To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.	6 months
Secondary	Collect baseline data	Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.	6 months