- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153631
Female Sexual Dysfunction in Breast Cancer Patients
Evaluating Female Sexual Dysfunction in Breast Cancer Patients After Mastectomy
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessment of female sexual dysfunction in breast cancer patients after mastectomy using questionaire
Time Frame: one month
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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. doi: 10.1002/pon.991.
- 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.
- 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.
- Chapman RM. Effect of cytotoxic therapy on sexuality and gonadal function. Semin Oncol. 1982 Mar;9(1):84-94.
- 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. doi: 10.1001/jama.249.6.751.
- 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. doi: 10.1080/00926239908404006.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fsdbc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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