Hormonal TherapyMetaCa2NCT02509871
Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2)
A study testing Body composition measurement in people with Hormonal Therapy and Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormonal Therapy, Breast Cancer
- What is being tested?
- Body composition measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Nov 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal women
- patients requiring hormonal treatment
- WHO performance status 0-2
- patients initially included in MetaCa (AU882) protocol
- Affiliation to a social security scheme (or be the beneficiary of such a plan)
- patients who signed the informed consent form
Who cannot join
- patients witg relapse, with metastases or other cancer
- concurrent treatment with a drug test, or participation in a clinical trial within < 30 days
- patients carrying an electronic medical device (eg pacemaker)
- patients who refused to sign the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer
This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).
- Conditions
- Hormonal Therapy, Breast Cancer
- Being tested
- Body composition measurement
- Keywords
- Body composition
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body composition measurementOther
DXA, impedance
| Study group | Role | What they receive |
|---|---|---|
| Body composition measurement | Other | DXA, impedance Receives: Other: Body composition measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of body composition
To obtain additional data to those of Metaca study (AU882) to assess changes in body composition (fat mass, lean body mass in Kg) in women with breast cancer and treated with adjuvant hormonal therapy following chemotherapy
Measured: After more than a year of hormonal therapy
Secondary outcomes (5)
Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference
Measured: After more than a year of hormonal therapy
Assessment of anxiety and depression scores measured by Questionnaire HAD
Questionnaire HAD
Measured: After more than a year of hormonal therapy
Evaluation of quality of life measured by Questionnaire (QLQ-C30)
Questionnaire (QLQ-C30)
Measured: After more than a year of hormonal therapy
Evaluation of the time sitting measured by Questionnaire IPAQ
Questionnaire IPAQ
Measured: After more than a year of hormonal therapy
Evaluate the change in body composition longitudinally from the data of the study Metaca
Measured: Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormonal TherapyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DURANDO, MD, PhD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509871
- Sponsor's protocol ID
- 2015-A00633-46
- Acronym
- MetaCa2
- Status last verified
- Dec 2018
- First submitted
- 23 Jul 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ginzac A, Thivat E, Mouret-Reynier MA, Dubray-Longeras P, Van Praagh I, Passildas J, Abrial C, Kwiatkowski F, Boirie Y, Duclos M, Morio B, Gadea E, Durando X. Weight Evolution During Endocrine Therapy for Breast Cancer in Postmenopausal Patients: Effect of Initial Fat Mass Percentage and Previous Adjuvant Treatments. Clin Breast Cancer. 2018 Oct;18(5):e1093-e1102. doi: 10.1016/j.clbc.2018.06.010. Epub 2018 Jun 18.
PubMed 30417829
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02509871
- Acronym / sponsor ID
- MetaCa2 / 2015-A00633-46
- Conditions
- Hormonal Therapy, Breast Cancer
- Keywords
- Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Jul 2015 (estimated)
- 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.
This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body composition measurement | Other | Other: Body composition measurementDXA, impedance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- postmenopausal women
- patients requiring hormonal treatment
- WHO performance status 0-2
- patients initially included in MetaCa (AU882) protocol
- Affiliation to a social security scheme (or be the beneficiary of such a plan)
Key exclusion criteria (4 listed)
- patients witg relapse, with metastases or other cancer
- concurrent treatment with a drug test, or participation in a clinical trial within < 30 days
- patients carrying an electronic medical device (eg pacemaker)
- patients who refused to sign the consent form
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 |
|---|---|---|
| Body composition measurementDXA, impedance | Other | Body composition measurement |
Primary outcome
Measure of body composition
Time frame: After more than a year of hormonal therapy
To obtain additional data to those of Metaca study (AU882) to assess changes in body composition (fat mass, lean body mass in Kg) in women with breast cancer and treated with adjuvant hormonal therapy following chemotherapy
5 secondary outcomes
Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference
Time frame: After more than a year of hormonal therapy
Assessment of anxiety and depression scores measured by Questionnaire HAD
Time frame: After more than a year of hormonal therapy
Evaluation of quality of life measured by Questionnaire (QLQ-C30)
Time frame: After more than a year of hormonal therapy
Evaluation of the time sitting measured by Questionnaire IPAQ
Time frame: After more than a year of hormonal therapy
Evaluate the change in body composition longitudinally from the data of the study Metaca
Time frame: Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy
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 19 Dec 2018.
- Results publication: PubMed 30417829Ginzac A, Thivat E, Mouret-Reynier MA, Dubray-Longeras P, Van Praagh I, Passildas J, Abrial C, Kwiatkowski F, Boirie Y, Duclos M, Morio B, Gadea E, Durando X. Weight Evolution During Endocrine Therapy for Breast Cancer in Postmenopausal Patients: Effect of Initial Fat Mass Percentage and Previous Adjuvant Treatments. Clin Breast Cancer. 2018 Oct;18(5):e1093-e1102. doi: 10.1016/j.clbc.2018.06.010. Epub 2018 Jun 18.
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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.
Xavier DURANDO, MD, PhD principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body composition measurement in people with Hormonal Therapy and Breast Cancer, run by Centre Jean Perrin 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 4 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 19 Dec 2018. 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?
Measure of body composition (time frame: After more than a year of hormonal therapy). 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 NCT02509871, which also lists 1 linked publication.
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 19 Dec 2018.