Female Breast CancerNCT03153631
Female Sexual Dysfunction in Breast Cancer Patients
An observational study of Female Breast Cancer, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Female Breast Cancer
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2018
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Seventy five female, with cancer breast who did mastectomy at child bearing period, will be recruited from the outpatient clinic of clinical oncology department in Assiut University hospital and South Egypt Cancer Institute.
Who may be able to join
- 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)
Who cannot join
- Pregnant women.
- Comorbidities (Diabetes mellitus., Hypertension).
- Female genital tract disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating Female Sexual Dysfunction in Breast Cancer Patients After Mastectomy
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.
Read the 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.
- Conditions
- Female Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa H Bery, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153631
- Sponsor's protocol ID
- fsdbc
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23008322Chapman RM. Effect of cytotoxic therapy on sexuality and gonadal function. Semin Oncol. 1982 Mar;9(1):84-94.
PubMed 6176028Derogatis 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.
PubMed 6823028Ferlay 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.
PubMed 25220842Katz 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.
PubMed 10546167Fobair 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.
PubMed 16287197Sadovsky 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.
PubMed 20092444
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Female Sexual Dysfunction in Breast Cancer Patients After Mastectomy
- ClinicalTrials.gov ID
- NCT03153631
- Acronym / sponsor ID
- fsdbc
- Conditions
- Female Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 May 2017 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Seventy five female, with cancer breast who did mastectomy at child bearing period, will be recruited from the outpatient clinic of clinical oncology department in Assiut University hospital and South Egypt Cancer Institute.
Key inclusion criteria (5 listed)
- Age: 18-40 years old.
- Social status: Married.
- (Performance status): Who 0-1
Key exclusion criteria (3 listed)
- Pregnant women.
- Comorbidities (Diabetes mellitus., Hypertension).
- Female genital tract disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 23008322Bober 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.
- Background: PubMed 6176028Chapman RM. Effect of cytotoxic therapy on sexuality and gonadal function. Semin Oncol. 1982 Mar;9(1):84-94.
- Background: PubMed 6823028Derogatis 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.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 10546167Katz 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.
- Background: PubMed 16287197Fobair 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.
- Background: PubMed 20092444Sadovsky 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Breast Cancer, run by Assiut University.
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 5 inclusion and 3 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dalia Abd El-Aziz Ahmed, MD (00201005677229, daliaattallah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of female sexual dysfunction in breast cancer patients after mastectomy using questionaire (time frame: one month). 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 NCT03153631, which also lists 7 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 16 May 2017.