Overweight or Obese Breast Cancer PatientsMEDEANCT04304924
Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer
A study testing The personalized telephone based intervention in people with Overweight or Obese Breast Cancer Patients, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The primary objective of MEDEA is to compare the effect of a personalised telephone-based health education weight loss program based on motivational coaching, exercise and diet versus a standard health educational program control on fatigue of overweight or obese BC patients (as measured by the EORTC QLQ C30 (Aaronson… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overweight or Obese Breast Cancer Patients
- What is being tested?
- The personalized telephone based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2020to 22 May 2025
- 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
- This study will be focused on an overweight/obese (BMI ≥25 kg/m2) population of patients with early BC. Particularly, patients will be eligible if they have:
- Documentation of Disease:
- Subjects must have histologically confirmed invasive BC and registration must occur within 12 months after the end of active treatment,
- Bilateral breast carcinoma is allowed,
- Patients must have Stage I toIII BC and no evidence of distant metastatic or locally recurrent disease,
- No history of invasive BC in 5 years prior to study registration other than the current diagnosis (prior Ductal Carcinoma in situ (DCIS) at any time does not make a patient ineligible).
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- Documentation of overweight/obesity: Subjects must have a BMI ≥25 kg/m2 objectively assessed at the time of eligibility evaluation or reported in the medical records within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is <25 then the patient is not eligible to enroll.
- Prior Treatment :
- All adjuvant or neoadjuvant CT, radiation, and surgery completed at least 21 days prior to registration to a maximum of 365 days after the end of treatment,
- Patients may have breast reconstruction during protocol participation, but definitive BC surgery must be completed at least 21 days prior to registration,
- Biologic therapy, hormonal therapy, and bisphosphonates are acceptable.
- Other:
- Age ≥ 18 years,
- ECOG Performance Status 0 or 1,
- Self-reported ability to walk at least 400 metres (at any pace),
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol,
- Patients must be affiliated to a social security system or beneficiary of the same.
Who cannot join
- Participation in another clinical study with an investigational product that has Fatigue as a known frequent adverse effects during the last 3 months and while on study treatment,
- Participating in another weight loss, physical activity or dietary intervention clinical trial. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial,
- Comorbid conditions, such as other malignancy, diabetes, inflammatory bowel disease, history of severe cardiovascular, respiratory or musculoskeletal disease that would preclude adherence to the study diet or physical activity program or significantly affect the physical status, or the ability to give an informed consent,
- Secondary overweight or obesity documented or suspected,
- Chronic consumption of corticosteroids,
- Self reported pregnancy or intent to become pregnant in the year after enrollement,
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of MEDEA is to compare the effect of a personalised telephone-based health education weight loss program based on motivational coaching, exercise and diet versus a standard health educational program control on fatigue of overweight or obese BC patients (as measured by the EORTC QLQ C30 (Aaronson et al. 1993; Sprangers et al. 1996))
- Being tested
- The personalized telephone based intervention
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The personalized telephone based interventionOther
The personalized telephone based intervention:
- Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989);
- Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises.
| Study group | Role | What they receive |
|---|---|---|
| Personalised telephone-based health education | Experimental | The personalized telephone based intervention:
1. Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989);
2. Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises. Receives: Other: The personalized telephone based intervention |
| Standard health educational program | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
will be assessed using the EORTC QLQ-C30 questionnaire
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 posted12 Mar 2020
- Study start17 Jun 2020
- Primary completion21 Jun 2023
- Study completion22 May 2025
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 Overweight or Obese Breast Cancer PatientsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial that compares two weight loss programs (control health education program vs. personalized telephone-based health education program) for overweight patients with early breast cancer
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304924
- Sponsor's protocol ID
- 2019-A02374-53
- Other IDs
- 2019/2986
- Acronym
- MEDEA
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2020
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Di Meglio A, Martin E, Crane TE, Charles C, Barbier A, Raynard B, Mangin A, Tredan O, Bouleuc C, Cottu PH, Vanlemmens L, Segura-Djezzar C, Lesur A, Pistilli B, Joly F, Ginsbourger T, Coquet B, Pauporte I, Jacob G, Sirven A, Bonastre J, Ligibel JA, Michiels S, Vaz-Luis I. A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design. Trials. 2022 Mar 4;23(1):193. doi: 10.1186/s13063-022-06090-6.
PubMed 35246219
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer
- ClinicalTrials.gov ID
- NCT04304924
- Acronym / sponsor ID
- MEDEA / 2019-A02374-53
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 12 Mar 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.
The primary objective of MEDEA is to compare the effect of a personalised telephone-based health education weight loss program based on motivational coaching, exercise and diet versus a standard health educational program control on fatigue of overweight or obese BC patients (as measured by the EORTC QLQ C30 (Aaronson et al. 1993; Sprangers et al. 1996))
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial that compares two weight loss programs (control health education program vs. personalized telephone-based health education program) for overweight patients with early breast cancer
| Arm | Type | Receives |
|---|---|---|
| Personalised telephone-based health education | Experimental | Other: The personalized telephone based interventionThe personalized telephone based intervention: 1. Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989); 2. Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises. |
| Standard health educational program | 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 (17 listed)
- This study will be focused on an overweight/obese (BMI ≥25 kg/m2) population of patients with early BC. Particularly, patients will be eligible if they have:
- Documentation of Disease:
- Documentation of overweight/obesity: Subjects must have a BMI ≥25 kg/m2 objectively assessed at the time of eligibility evaluation or reported in the medical records within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is <25 then the patient is not eligible to enroll.
- Prior Treatment :
- Other:
Key exclusion criteria (7 listed)
- Participation in another clinical study with an investigational product that has Fatigue as a known frequent adverse effects during the last 3 months and while on study treatment,
- Participating in another weight loss, physical activity or dietary intervention clinical trial. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial,
- Comorbid conditions, such as other malignancy, diabetes, inflammatory bowel disease, history of severe cardiovascular, respiratory or musculoskeletal disease that would preclude adherence to the study diet or physical activity program or significantly affect the physical status, or the ability to give an informed consent,
- Secondary overweight or obesity documented or suspected,
- Chronic consumption of corticosteroids,
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 |
|---|---|---|
| The personalized telephone based interventionThe personalized telephone based intervention: 1. Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989); 2. Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises. | Other | Personalised telephone-based health education |
Primary outcome
Fatigue
Time frame: up to 12 months
will be assessed using the EORTC QLQ-C30 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 Apr 2026.
- Derived from this study: PubMed 35246219Di Meglio A, Martin E, Crane TE, Charles C, Barbier A, Raynard B, Mangin A, Tredan O, Bouleuc C, Cottu PH, Vanlemmens L, Segura-Djezzar C, Lesur A, Pistilli B, Joly F, Ginsbourger T, Coquet B, Pauporte I, Jacob G, Sirven A, Bonastre J, Ligibel JA, Michiels S, Vaz-Luis I. A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design. Trials. 2022 Mar 4;23(1):193. doi: 10.1186/s13063-022-06090-6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The personalized telephone based intervention in people with Overweight or Obese Breast Cancer Patients, 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 17 inclusion and 7 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 Apr 2026. 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?
Fatigue (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 NCT04304924, 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 1 Apr 2026.