Breast CancerNCT01506466
Weight Variation During Chemotherapy in Breast Cancer Patients
A study testing blood test/ additional measurement in people with Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- blood test/ additional measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Jan 2014
- 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 Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- menopausal women
- breast cancer
- patients requiring chemotherapy treatment
- WHO performance status 0-2
Who cannot join
- diabetics
- patients with metastases
- other cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.
Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.
- Conditions
- Breast Cancer
- Being tested
- blood test/ additional measurement
- Keywords
- chemotherapy, metabolism, weight, body composition
- Medical subject headings
- Breast Neoplasms, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood test/ additional measurementOther
blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation
| Study group | Role | What they receive |
|---|---|---|
| additional examinations/measurements | Other | Not described Receives: Other: blood test/ additional measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body composition
Measured: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Secondary outcomes (3)
Change from baseline in energy balance
resting energy expenditure, physical activity, food records.
Measured: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Change from baseline in muscle strength
Measured: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors)
Measured: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT01506466
- Sponsor's protocol ID
- 2011-A00206-35
- Status last verified
- Jul 2015
- First submitted
- 3 Jan 2012
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01506466
- Acronym / sponsor ID
- 2011-A00206-35
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, metabolism, weight, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Jan 2012 (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.
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.
Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| additional examinations/measurements | Other | Other: blood test/ additional measurement |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- menopausal women
- breast cancer
- patients requiring chemotherapy treatment
- WHO performance status 0-2
Key exclusion criteria (3 listed)
- diabetics
- patients with metastases
- other cancer
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 |
|---|---|---|
| blood test/ additional measurementblood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation | Other | additional examinations/measurements |
Primary outcome
Change from baseline in body composition
Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
3 secondary outcomes
Change from baseline in energy balance
Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Change from baseline in muscle strength
Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors)
Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
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 24 Jul 2015.
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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 blood test/ additional measurement in people with 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 4 inclusion and 3 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 24 Jul 2015. 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?
Change from baseline in body composition (time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.). 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 24 Jul 2015.