Breast CancerCUPIDON2NCT04200001
Evaluation of Sexual Quality of Life for Breast Cancer
An observational study of Breast Cancer and Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Breast Cancer, Cancer, Quality of Life
- What is being tested?
- Quality of life
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 31 Jul 2020
- 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 51 years
- Women only
- No healthy volunteers
- Adult
Study population: Women less than 51 years old, during adjuvant hormonal therapy for breast cancer.
Who may be able to join
- Female age ≥ 18 years old and less than 51 years old.
- Patient with non-metastatic early breast cancer,
- Patient undergoing adjuvant hormonal therapy for at least 2 years,
- Patient who has been treated by surgery, with or without chemotherapy and/or radiotherapy.
- Patient being currently sexually active.
- Patient who agreed, after receiving information, to participate to the study.
Who cannot join
- Patient who refused to participate to this study or is unable to fulfill a questionnaire,
- Patient not affiliated to the French social security system,
- Subject under tutelage, curatorship or safeguard of justice,
- Patient in an emergency situation,
- Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
- Pregnant and / or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sexual Quality of Life in Women Less Than 51 Years Old, During Adjuvant Hormonal Therapy for Breast Cancer
Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects.
According to the third "Plan Cancer" (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered.
Read more
In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods.
This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care.
Read the detailed description
In 2006, the World Health Organization provided a definition of sexual health stating that "for sexual health to be reached and maintained, the sexual rights of all persons must be respected and fulfilled". Sexual quality of life is now an admitted and relevant parameter of global health and global quality of life.
The VICAN 2 (Vie après le CANcer 2 years after diagnosis) survey showed that 2/3 of the sexually active French breast cancer survivors reported impaired sexual health, persisting 2 years after cancer diagnosis.
The deterioration of sexual health is multifactorial: (1) psychological: body image, sexual identity; (2) physiological: sexual functionality, steps of the feminine sexual response; (3) familial, social and professional. The alteration of sexuality is mainly due to cancer treatments: surgery, radiotherapy, chemotherapy and endocrine therapy.
Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects.
According to the third "Plan Cancer" (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered.
In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods.
This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care.
- Conditions
- Breast Cancer, Cancer, Quality of Life
- Being tested
- Quality of life
- Keywords
- breast cancer, hormonotherapy, women, quality of life
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeOther
The patient will receive the following questionnaires to be completed :
- EORTC QLQ-C30
- EORTC QLQ-BR23
- EORTC SHQ-C22
- CUPIDON 2 specific questionnaire
| Study group | Role | What they receive |
|---|---|---|
| adjuvant hormonal therapy for breast cancer | women less than 51 years old, during adjuvant hormonal therapy for breast cancer Receives: Other: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual quality of life: EORTC SHQ-C22 questionnaire
Sexual quality of life assessed by the EORTC SHQ-C22 questionnaire
Measured: At the inclusion, at one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start10 Feb 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique D'HONDT, MD, Study chair, Institut Régional du Cancer de Montpellier (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200001
- Sponsor's protocol ID
- PROICM 2019-16-BCU
- Acronym
- CUPIDON2
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pouget JP, Lozza C, Deshayes E, Boudousq V, Navarro-Teulon I. Introduction to radiobiology of targeted radionuclide therapy. Front Med (Lausanne). 2015 Mar 17;2:12. doi: 10.3389/fmed.2015.00012. eCollection 2015.
PubMed 25853132Kumar C, Shetake N, Desai S, Kumar A, Samuel G, Pandey BN. Relevance of radiobiological concepts in radionuclide therapy of cancer. Int J Radiat Biol. 2016;92(4):173-86. doi: 10.3109/09553002.2016.1144944. Epub 2016 Feb 26.
PubMed 26917443
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sexual Quality of Life in Women Less Than 51 Years Old, During Adjuvant Hormonal Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT04200001
- Acronym / sponsor ID
- CUPIDON2 / PROICM 2019-16-BCU
- Conditions
- Breast Cancer, Cancer, Quality of Life
- Keywords
- breast cancer, hormonotherapy, women, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 16 Dec 2019 (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 common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects.
According to the third "Plan Cancer" (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered.
In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods.
This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care.
Detailed description
In 2006, the World Health Organization provided a definition of sexual health stating that "for sexual health to be reached and maintained, the sexual rights of all persons must be respected and fulfilled". Sexual quality of life is now an admitted and relevant parameter of global health and global quality of life.
The VICAN 2 (Vie après le CANcer 2 years after diagnosis) survey showed that 2/3 of the sexually active French breast cancer survivors reported impaired sexual health, persisting 2 years after cancer diagnosis.
The deterioration of sexual health is multifactorial: (1) psychological: body image, sexual identity; (2) physiological: sexual functionality, steps of the feminine sexual response; (3) familial, social and professional. The alteration of sexuality is mainly due to cancer treatments: surgery, radiotherapy, chemotherapy and endocrine therapy.
Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects.
According to the third "Plan Cancer" (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered.
In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods.
This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adjuvant hormonal therapy for breast cancer | – | Other: Quality of lifewomen less than 51 years old, during adjuvant hormonal therapy for breast cancer |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women less than 51 years old, during adjuvant hormonal therapy for breast cancer.
Key inclusion criteria (6 listed)
- Female age ≥ 18 years old and less than 51 years old.
- Patient with non-metastatic early breast cancer,
- Patient undergoing adjuvant hormonal therapy for at least 2 years,
- Patient who has been treated by surgery, with or without chemotherapy and/or radiotherapy.
- Patient being currently sexually active.
Key exclusion criteria (6 listed)
- Patient who refused to participate to this study or is unable to fulfill a questionnaire,
- Patient not affiliated to the French social security system,
- Subject under tutelage, curatorship or safeguard of justice,
- Patient in an emergency situation,
- Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
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 |
|---|---|---|
| Quality of lifeThe patient will receive the following questionnaires to be completed : * EORTC QLQ-C30 * EORTC QLQ-BR23 * EORTC SHQ-C22 * CUPIDON 2 specific questionnaire | Other | adjuvant hormonal therapy for breast cancer |
Primary outcome
Sexual quality of life: EORTC SHQ-C22 questionnaire
Time frame: At the inclusion, at one time
Sexual quality of life assessed by the EORTC SHQ-C22 questionnaire
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 1 Mar 2021.
- Background: PubMed 25853132Pouget JP, Lozza C, Deshayes E, Boudousq V, Navarro-Teulon I. Introduction to radiobiology of targeted radionuclide therapy. Front Med (Lausanne). 2015 Mar 17;2:12. doi: 10.3389/fmed.2015.00012. eCollection 2015.
- Background: PubMed 26917443Kumar C, Shetake N, Desai S, Kumar A, Samuel G, Pandey BN. Relevance of radiobiological concepts in radionuclide therapy of cancer. Int J Radiat Biol. 2016;92(4):173-86. doi: 10.3109/09553002.2016.1144944. Epub 2016 Feb 26.
- 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.
Véronique D'HONDT, MD study chair
Institut Régional du Cancer de Montpellier (ICM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 6 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 1 Mar 2021. 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 France. 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?
Sexual quality of life: EORTC SHQ-C22 questionnaire (time frame: At the inclusion, at one time). 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 NCT04200001, which also lists 2 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 1 Mar 2021.