CancerLHRHaNCT06840847
Sexual Coercion in Breast Cancer Patients Treated With Luteinizing Hormone-Releasing Hormone Agonists (LHRHa )
A study testing Sexual Coercion in people with Cancer, run by Canan Kas at 1 site in Turkey (Türkiye).
Trial summary
The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Sexual Coercion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 29 Oct 2024
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- being over 18 years of age
- willingness to participate in this study
- having received treatment for breast cancer
- having a history of breast cancer surgery
- having an active relationship with a spouse or partner.
Who cannot join
- having any neuropsychiatric disorder
- having any mental illness
- having a history of gynecological surgery
- currently receiving active chemotherapy or less than 3 months since completing chemotherapy
- receiving treatment for metastatic disease
- The use of selective serotonin reuptake inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. However, this approach can lead to more severe and prolonged menopausal symptoms, which can further impact intimate relationships and sexual function. Sexual coercion, encompassing both overt and subtle forms of pressure, is a significant global public health concern that threatens individual well-being.
Read the detailed description
Objective: The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. However, this approach can lead to more severe and prolonged menopausal symptoms, which can further impact intimate relationships and sexual function. Sexual coercion, encompassing both overt and subtle forms of pressure, is a significant global public health concern that threatens individual well-being.
Methods: This study is a randomized controlled study. In this study, the validated Turkish version of the Sexual Coercion in Intimate Relationship Scale was utilized to investigate whether patients receiving LHRHa therapy experienced higher rates of sexual sexual coercion compared to those taking tamoxifen. The study included 40 patients using LHRHa and 39 patients using tamoxifen. The instrument assessed partner sexual coercion across three subdomains: resource manipulation/sexual coercion, commitment manipulation, and defection threat.
- Conditions
- Cancer
- Being tested
- Sexual Coercion
- Keywords
- breast cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual CoercionBehavioural
This study aimed to investigate whether patients receiving LHRHa treatment experienced sexual coercion at a higher rate than those using tamoxifen. 40 patients using LHRHa and 39 patients using tamoxifen were included in the study.
| Study group | Role | What they receive |
|---|---|---|
| LHRHa | Active comparator | In this study, included 40 patients on LHRHa. The instrument assessed partner sexual coercion in three domains: resource manipulation/sexual coercion, commitment manipulation, and threat of separation. Receives: Behavioral: Sexual Coercion |
| Tamoxifen (Nolvadex) | Active comparator | In this study included 39 patients on tamoxifen. The instrument assessed partner sexual coercion in three domains: resource manipulation/sexual coercion, commitment manipulation, and threat of separation. Receives: Behavioral: Sexual Coercion |
What is being measured
The primary outcome is the main question the study is designed to answer.
LHRHa
It was examined whether patients receiving LHRHa treatment were exposed to sexual pressure.
Measured: for 10 months
Tamoxifen
It was examined whether patients receiving tamoxifen treatment were exposed to sexual pressure.
Measured: for 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jan 2024
- Primary completion1 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canan Kas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Canan Kas, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840847
- Sponsor's protocol ID
- 2023-KAEK-148
- Other IDs
- Kastamonu Universty 2023/148
- Acronym
- LHRHa
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Coercion in Breast Cancer Patients Treated With Luteinizing Hormone-Releasing Hormone Agonists (LHRHa )
- ClinicalTrials.gov ID
- NCT06840847
- Acronym / sponsor ID
- LHRHa / 2023-KAEK-148
- Conditions
- Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Canan KasUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 21 Feb 2025 (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.
The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. However, this approach can lead to more severe and prolonged menopausal symptoms, which can further impact intimate relationships and sexual function. Sexual coercion, encompassing both overt and subtle forms of pressure, is a significant global public health concern that threatens individual well-being.
Detailed description
Objective: The use of luteinizing hormone-releasing hormone agonists(LHRHa) to suppress ovarian function is a common strategy for treating premenopausal, hormone receptor-positive breast cancer. However, this approach can lead to more severe and prolonged menopausal symptoms, which can further impact intimate relationships and sexual function. Sexual coercion, encompassing both overt and subtle forms of pressure, is a significant global public health concern that threatens individual well-being.
Methods: This study is a randomized controlled study. In this study, the validated Turkish version of the Sexual Coercion in Intimate Relationship Scale was utilized to investigate whether patients receiving LHRHa therapy experienced higher rates of sexual sexual coercion compared to those taking tamoxifen. The study included 40 patients using LHRHa and 39 patients using tamoxifen. The instrument assessed partner sexual coercion across three subdomains: resource manipulation/sexual coercion, commitment manipulation, and defection threat.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LHRHa | Active comparator | Behavioral: Sexual CoercionIn this study, included 40 patients on LHRHa. The instrument assessed partner sexual coercion in three domains: resource manipulation/sexual coercion, commitment manipulation, and threat of separation. |
| Tamoxifen (Nolvadex) | Active comparator | Behavioral: Sexual CoercionIn this study included 39 patients on tamoxifen. The instrument assessed partner sexual coercion in three domains: resource manipulation/sexual coercion, commitment manipulation, and threat of separation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- being over 18 years of age
- willingness to participate in this study
- having received treatment for breast cancer
- having a history of breast cancer surgery
- having an active relationship with a spouse or partner.
Key exclusion criteria (6 listed)
- having any neuropsychiatric disorder
- having any mental illness
- having a history of gynecological surgery
- currently receiving active chemotherapy or less than 3 months since completing chemotherapy
- receiving treatment for metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual CoercionThis study aimed to investigate whether patients receiving LHRHa treatment experienced sexual coercion at a higher rate than those using tamoxifen. 40 patients using LHRHa and 39 patients using tamoxifen were included in the study. | Behavioural | LHRHa, Tamoxifen (Nolvadex) |
Primary outcome
LHRHa
Time frame: for 10 months
It was examined whether patients receiving LHRHa treatment were exposed to sexual pressure.
Tamoxifen
Time frame: for 10 months
It was examined whether patients receiving tamoxifen treatment were exposed to sexual pressure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Coercion in people with Cancer, run by Canan Kas at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LHRHa (time frame: for 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.