Breast CancerCUPIDONNCT04539587
Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment 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 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer, Quality of Life
- What is being tested?
- Quality of life
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2018to 30 Oct 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients were minimum 18 years old, had hormone receptor-positive early BC, had all completed surgery as well as chemotherapy and/or radiotherapy, if indicated, and had begun their hormonal therapy for less than 6 months.
Who may be able to join
- Female age ≥ 18 years old
- Patient with non-metastatic early breast cancer,
- Patient undergoing adjuvant hormonal therapy
- 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: Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer: a Prospective Longitudinal Study
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
Breast cancer (BC) is the most common cancer in women worldwide, affecting approximately one in eight women during her lifetime in Western countries. (chiffres Globocan). Approximately two thirds of BC are hormone receptor-positive and the multimodal treatment will therefore include hormone therapy during 5 years or even longer (Burstein et al. 2019).
Many studies have described a wide range of disruptions in day to day living after breast cancer diagnosis and treatment. These physical, psychological and social concerns for the patients, related to the disease and its treatment, are now recognized as important outcomes in clinical trials and are evaluated in standardized Health-related quality of life (HRQL) questionnaires like the general EORTC QLQ-C30 dedicated to all cancer patients (Aaronson et al. 1993) or the EORTC QLQ-BR23 dedicated to breast cancer patients (Sprangers et al. 1996).
Sexual dysfunction is frequent during and after treatment for breast cancer (Ananth et al. 2003; Krychman et al. 2006; Pup et al. 2019) and is not specifically evaluated in these general HRQL questionnaires. Recently, the EORTC SHQ-C22 has been developed as a standardized instrument to evaluate sexual quality of life (QoL) in cancer patients to address and evaluate in more detail the sexual dysfunction related to the disease and the treatment(Oberguggenberger et al. 2018).
A prospective longitudinal assessment is conduted of the sexual functioning of women during the first year of adjuvant hormonal therapy using global HRQL questionnaires as well as the new SHQ-C22 questionnaire specifically dedicated to sexual QoL for cancer patients.
- 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
| Study group | Role | What they receive |
|---|---|---|
| adjuvant hormonal therapy for breast cancer | Women more than 18 years old, with hormone receptor-positive early BC, with completed surgery as well as chemotherapy and/or radiotherapy, if indicated, and had begun their hormonal therapy for less than 6 months. 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 day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start2 May 2018
- Primary completion30 Nov 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 106 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
- NCT04539587
- Sponsor's protocol ID
- PROICM 2018-05 BCU
- Acronym
- CUPIDON
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cavalheiro JA, Bittelbrunn A, Menke CH, Biazus JV, Xavier NL, Cericatto R, Schuh F, Pinheiro CV, Passos EP. Sexual function and chemotherapy in postmenopausal women with breast cancer. BMC Womens Health. 2012 Sep 11;12:28. doi: 10.1186/1472-6874-12-28.
PubMed 22963155Dow J, Kennedy Sheldon L. Breast Cancer Survivors and Sexuality: A Review of the Literature Concerning Sexual Functioning, Assessment Tools, and Evidence-Based Interventions. Clin J Oncol Nurs. 2015 Aug;19(4):456-61. doi: 10.1188/15.CJON.456-461.
PubMed 26207711Frechette D, Paquet L, Verma S, Clemons M, Wheatley-Price P, Gertler SZ, Song X, Graham N, Dent S. The impact of endocrine therapy on sexual dysfunction in postmenopausal women with early stage breast cancer: encouraging results from a prospective study. Breast Cancer Res Treat. 2013 Aug;141(1):111-7. doi: 10.1007/s10549-013-2659-y. Epub 2013 Aug 14.
PubMed 23942873Hummel SB, van Lankveld JJDM, Oldenburg HSA, Hahn DEE, Kieffer JM, Gerritsma MA, Kuenen MA, Bijker N, Borgstein PJ, Heuff G, Lopes Cardozo AMF, Plaisier PW, Rijna H, van der Meij S, van Dulken EJ, Vrouenraets BC, Broomans E, Aaronson NK. Efficacy of Internet-Based Cognitive Behavioral Therapy in Improving Sexual Functioning of Breast Cancer Survivors: Results of a Randomized Controlled Trial. J Clin Oncol. 2017 Apr 20;35(12):1328-1340. doi: 10.1200/JCO.2016.69.6021. Epub 2017 Feb 27.
PubMed 28240966
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer: a Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT04539587
- Acronym / sponsor ID
- CUPIDON / PROICM 2018-05 BCU
- Conditions
- Breast Cancer, Cancer, Quality of Life
- Keywords
- breast cancer, hormonotherapy, women, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 7 Sep 2020 (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
Breast cancer (BC) is the most common cancer in women worldwide, affecting approximately one in eight women during her lifetime in Western countries. (chiffres Globocan). Approximately two thirds of BC are hormone receptor-positive and the multimodal treatment will therefore include hormone therapy during 5 years or even longer (Burstein et al. 2019).
Many studies have described a wide range of disruptions in day to day living after breast cancer diagnosis and treatment. These physical, psychological and social concerns for the patients, related to the disease and its treatment, are now recognized as important outcomes in clinical trials and are evaluated in standardized Health-related quality of life (HRQL) questionnaires like the general EORTC QLQ-C30 dedicated to all cancer patients (Aaronson et al. 1993) or the EORTC QLQ-BR23 dedicated to breast cancer patients (Sprangers et al. 1996).
Sexual dysfunction is frequent during and after treatment for breast cancer (Ananth et al. 2003; Krychman et al. 2006; Pup et al. 2019) and is not specifically evaluated in these general HRQL questionnaires. Recently, the EORTC SHQ-C22 has been developed as a standardized instrument to evaluate sexual quality of life (QoL) in cancer patients to address and evaluate in more detail the sexual dysfunction related to the disease and the treatment(Oberguggenberger et al. 2018).
A prospective longitudinal assessment is conduted of the sexual functioning of women during the first year of adjuvant hormonal therapy using global HRQL questionnaires as well as the new SHQ-C22 questionnaire specifically dedicated to sexual QoL for cancer patients.
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 more than 18 years old, with hormone receptor-positive early BC, with completed surgery as well as chemotherapy and/or radiotherapy, if indicated, and had begun their hormonal therapy for less than 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients were minimum 18 years old, had hormone receptor-positive early BC, had all completed surgery as well as chemotherapy and/or radiotherapy, if indicated, and had begun their hormonal therapy for less than 6 months.
Key inclusion criteria (6 listed)
- Female age ≥ 18 years old
- Patient with non-metastatic early breast cancer,
- Patient undergoing adjuvant hormonal therapy
- 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 | Other | adjuvant hormonal therapy for breast cancer |
Primary outcome
Sexual quality of life: EORTC SHQ-C22 questionnaire
Time frame: At the inclusion, at day 1
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 13 Feb 2025.
- Background: PubMed 22963155Cavalheiro JA, Bittelbrunn A, Menke CH, Biazus JV, Xavier NL, Cericatto R, Schuh F, Pinheiro CV, Passos EP. Sexual function and chemotherapy in postmenopausal women with breast cancer. BMC Womens Health. 2012 Sep 11;12:28. doi: 10.1186/1472-6874-12-28.
- Background: PubMed 26207711Dow J, Kennedy Sheldon L. Breast Cancer Survivors and Sexuality: A Review of the Literature Concerning Sexual Functioning, Assessment Tools, and Evidence-Based Interventions. Clin J Oncol Nurs. 2015 Aug;19(4):456-61. doi: 10.1188/15.CJON.456-461.
- Background: PubMed 23942873Frechette D, Paquet L, Verma S, Clemons M, Wheatley-Price P, Gertler SZ, Song X, Graham N, Dent S. The impact of endocrine therapy on sexual dysfunction in postmenopausal women with early stage breast cancer: encouraging results from a prospective study. Breast Cancer Res Treat. 2013 Aug;141(1):111-7. doi: 10.1007/s10549-013-2659-y. Epub 2013 Aug 14.
- Background: PubMed 28240966Hummel SB, van Lankveld JJDM, Oldenburg HSA, Hahn DEE, Kieffer JM, Gerritsma MA, Kuenen MA, Bijker N, Borgstein PJ, Heuff G, Lopes Cardozo AMF, Plaisier PW, Rijna H, van der Meij S, van Dulken EJ, Vrouenraets BC, Broomans E, Aaronson NK. Efficacy of Internet-Based Cognitive Behavioral Therapy in Improving Sexual Functioning of Breast Cancer Survivors: Results of a Randomized Controlled Trial. J Clin Oncol. 2017 Apr 20;35(12):1328-1340. doi: 10.1200/JCO.2016.69.6021. Epub 2017 Feb 27.
- 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 13 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 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 day 1). 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 NCT04539587, which also lists 4 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 13 Feb 2025.