Female Sexual Dysfunction in Breast Cancer Patients

Female Breast Cancer Clinical Trial

Official title:

Evaluating Female Sexual Dysfunction in Breast Cancer Patients After Mastectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03153631
• Other study ID #: fsdbc
• Status: Not yet recruiting
• Phase: N/A
• First received: May 12, 2017
• Last updated: May 13, 2017
• Start date: July 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Dalia Abd El-Aziz Ahmed, MD
• Phone: 00201005677229
• Email: daliaattallah[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females world wide. breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females.

Description:

In Egypt, cancer breast is one of the commonest cancers among females representing 38.8%.cancer breast among females ranked the top with a high frequency in lower, middle, upper Egypt (33.8%,26.8%,38.7% resp.).

Women who developed breast cancer were more amenable than women who remained free of breast carcinoma to experience reduced physical function, vitality, social function.

Difficulties related to sexuality and sexual functioning were common and occurred soon after surgical and adjuvant treatment. addressing these problems is essential to improve the quality of life of young women with breast cancer.

Sexuality is a basic and important domain of human experience that can be damaged during and following cancer treatment. The risk of sexual dysfunction is even of greater importance among young cancer patients and survivors, with young breast cancer patients at particularly high risk.

In cancer breast patients, various factors can induce sexual dysfunction. Some of these factors; hormonal alterations induced by chemotherapy and radiotherapy, or physiological and functional disturbances are related to the deterioration of physical condition. These factors are strictly clinical.

Other factors which induce disturbances in sexual behavior, such as anxious\ depressive reactions in adapting to illness and treatment and cancerophobic reactions and loss of self esteem that accompany any illness are more psychological\ psychiatric in nature.

Having sexual problems (or dysfunction) includes experiencing disturbances in sexual desire and physiological changes associated with loss of sexual desire and arousal, reduction in sexual pleasure, difficulty achieving orgasm, anxiety about sexual performance and pain during intercourse.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age: 18-40 years old.

• Social status: Married.

• (Performance status): Who 0-1

• 0-Asymptomatic (fully active, able to carry on all predisease activities without restriction)

• 1-Symptomatic but completely ambulatory (restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature. For example, light housework, office work)

Exclusion Criteria:

• Pregnant women.

• Comorbidities (Diabetes mellitus., Hypertension).

• Female genital tract disease.

Related Conditions & MeSH terms

• Breast Neoplasms
• Female Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Bober SL, Varela VS. Sexuality in adult cancer survivors: challenges and intervention. J Clin Oncol. 2012 Oct 20;30(30):3712-9. doi: 10.1200/JCO.2012.41.7915. Epub 2012 Sep 24. Review. — View Citation

Chapman RM. Effect of cytotoxic therapy on sexuality and gonadal function. Semin Oncol. 1982 Mar;9(1):84-94. — View Citation

Derogatis LR, Morrow GR, Fetting J, Penman D, Piasetsky S, Schmale AM, Henrichs M, Carnicke CL Jr. The prevalence of psychiatric disorders among cancer patients. JAMA. 1983 Feb 11;249(6):751-7. — View Citation

Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. — View Citation

Fobair P, Stewart SL, Chang S, D'Onofrio C, Banks PJ, Bloom JR. Body image and sexual problems in young women with breast cancer. Psychooncology. 2006 Jul;15(7):579-94. — View Citation

Katz RC, Jardine D. The relationship between worry, sexual aversion, and low sexual desire. J Sex Marital Ther. 1999 Oct-Dec;25(4):293-6. — View Citation

Sadovsky R, Basson R, Krychman M, Morales AM, Schover L, Wang R, Incrocci L. Cancer and sexual problems. J Sex Med. 2010 Jan;7(1 Pt 2):349-73. doi: 10.1111/j.1743-6109.2009.01620.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of female sexual dysfunction in breast cancer patients after mastectomy using questionaire	description of manner of female sexual dysfunction after mastectomy using Arabic Female Sexual Function Index and FEMALE SEXUAL FUNCTION INDEX DOMAIN SCORES AND FULL SCALE SCORE	one month