Breast CancerPhase 3BEAUTYNCT01459003
Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer
A Phase 3 study testing beauty care in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- beauty care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Apr 2014
- Phase
- Phase 3
- 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
- breast cancer with no metastasis receiving adjuvant chemotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer
- Conditions
- Breast Cancer
- Being tested
- beauty care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beauty careOther
beauty care performed before each chemo cycle
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Other: beauty care |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life questionnaire
body image
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahasti Saghatchian, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459003
- Sponsor's protocol ID
- 2011-A00811-40
- Other IDs
- 2010/1632
- Acronym
- BEAUTY
- Status last verified
- May 2014
- First submitted
- 24 Oct 2011
- Last updated
- 6 May 2014
- Results posted
- No
Publications
Saghatchian M, Lacas B, Charles C, Ghouadni A, Clain GT, Boinon D, Delaloge S, Vaz-Luis I, Dauchy S, Amiel P. BEAUTY and the breast: is adjuvant chemotherapy the right time for a beauty boost? Lessons learned from a large randomized controlled trial. Qual Life Res. 2022 Mar;31(3):723-732. doi: 10.1007/s11136-021-02947-6. Epub 2021 Jul 29.
PubMed 34324138
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01459003
- Acronym / sponsor ID
- BEAUTY / 2011-A00811-40
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Oct 2011 (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.
Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: beauty care |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- breast cancer with no metastasis receiving adjuvant chemotherapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| beauty carebeauty care performed before each chemo cycle | Other | experimental |
Primary outcome
quality of life questionnaire
Time frame: up to 12 months
body image
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 6 May 2014.
- Derived from this study: PubMed 34324138Saghatchian M, Lacas B, Charles C, Ghouadni A, Clain GT, Boinon D, Delaloge S, Vaz-Luis I, Dauchy S, Amiel P. BEAUTY and the breast: is adjuvant chemotherapy the right time for a beauty boost? Lessons learned from a large randomized controlled trial. Qual Life Res. 2022 Mar;31(3):723-732. doi: 10.1007/s11136-021-02947-6. Epub 2021 Jul 29.
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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.
Mahasti Saghatchian, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing beauty care in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris 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 1 inclusion and 0 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 6 May 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
quality of life questionnaire (time frame: up to 12 months). 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 NCT01459003, 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 6 May 2014.