Breast CancerNCT04045392
Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients
A study testing Mediterranean diet in people with Breast Cancer and Obesity, run by Gangnam Severance Hospital.
Trial summary
The purpose of this randomized clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation and metabolic risk factors in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Obesity
- What is being tested?
- Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Aug 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer patients who are receiving adjuvant hormone therapy after diagnosed with breast cancer stage Ⅰ-Ⅲ and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy
- Postmenopausal women
- Body mass index (BMI) ≥23 kg/m2
- Able to speak and read Korean
- Able to comply with all required study procedures and schedule
- Willing and able to give written informed consent
Who cannot join
- Participants with cancer recurrence or metastasis
- Participants with weight change more than 5kg in the previous 3 months
- Participants with secondary causes of obesity, such as hypothyroidism
- Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL)
- Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
- Participants who are taking weight loss medications
Show all 9Show fewer
- Participants who are receiving systemic corticosteroid therapy
- Participants with alcohol abuse or dependence
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
About this study
Official title: Effects of Mediterranean Diet Based Intervention in Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: the Randomized Controlled Trial
The purpose of this randomized clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation and metabolic risk factors in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy.
- Conditions
- Breast Cancer, Obesity
- Being tested
- Mediterranean diet
- Medical subject headings
- Breast Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietBehavioural
Two meals (breakfast and dinner) a day, five times a week, are delivered to participants' homes without charge. The meals are prepared, under the supervision of an expert nutritionist, by a chef trained on the principles of the Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet group | Experimental | Mediterranean diet with calorie restriction below 1,500 kcal per day. Receives: Behavioral: Mediterranean diet |
| Conventional diet group | No intervention | Conventional diet with calorie restriction below 1,500 kcal per day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C-Reactive Protein (CRP) levels
Blood will be drawn from the participants for assessment of CRP levels (mg/L)
Measured: Baseline, 8 weeks
Change in fasting insulin levels
Blood will be drawn from the participants for assessment of fasting insulin levels (mcIU/mL) after fasting for at least 8 hours
Measured: Baseline, 8 weeks
Change in fasting glucose levels
Blood will be drawn from the participants for assessment of fasting glucose levels (mg/dL) after fasting for at least 8 hours
Measured: Baseline, 8 weeks
Change in lipid profile
Blood will be drawn from the participants for assessment of total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol (mg/dL) after fasting for at least 8 hours
Measured: Baseline, 8 weeks
Secondary outcomes (4)
Change in body weight
We will measure body weight (kg) of participants using the same scale
Measured: Baseline, 8 weeks
Change in fat mass measured by bioelectrical impedance analyzer
We will measure fat mass (kg) using bioelectrical impedance analyzer
Measured: Baseline, 8 weeks
Change in quality of life assessed by EORTC QLQ-C30 questionnaire
Quality of life will be assessed by questionnaire, named European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), score range 0~100, higher scores indicate better quality of life
Measured: Baseline, 8 weeks
Change in quality of life assessed by OP scale questionnaire
Quality of life will be assessed by questionnaire, named Obesity-related problems scale (OP scale), scale range 0~100, higher scores indicate more problems
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Won Lee, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045392
- Sponsor's protocol ID
- 3-2019-0140
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho AR, Hong KW, Kwon YJ, Choi JE, Lee HS, Kim HM, Bae SJ, Ahn SG, Jeong J, Lee JW. Effects of Single Nucleotide Polymorphisms and Mediterranean Diet in Overweight or Obese Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: A Pilot Randomized Controlled Trial. Front Nutr. 2022 Jul 1;9:882717. doi: 10.3389/fnut.2022.882717. eCollection 2022.
PubMed 35845810
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mediterranean Diet Based Intervention in Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: the Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04045392
- Acronym / sponsor ID
- 3-2019-0140
- Conditions
- Breast Cancer, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 5 Aug 2019 (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 purpose of this randomized clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation and metabolic risk factors in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet group | Experimental | Behavioral: Mediterranean dietMediterranean diet with calorie restriction below 1,500 kcal per day. |
| Conventional diet group | No intervention | –Conventional diet with calorie restriction below 1,500 kcal per day. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Breast cancer patients who are receiving adjuvant hormone therapy after diagnosed with breast cancer stage Ⅰ-Ⅲ and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy
- Postmenopausal women
- Body mass index (BMI) ≥23 kg/m2
- Able to speak and read Korean
- Able to comply with all required study procedures and schedule
Key exclusion criteria (9 listed)
- Participants with cancer recurrence or metastasis
- Participants with weight change more than 5kg in the previous 3 months
- Participants with secondary causes of obesity, such as hypothyroidism
- Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL)
- Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
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 |
|---|---|---|
| Mediterranean dietTwo meals (breakfast and dinner) a day, five times a week, are delivered to participants' homes without charge. The meals are prepared, under the supervision of an expert nutritionist, by a chef trained on the principles of the Mediterranean diet. | Behavioural | Mediterranean diet group |
Primary outcome
Change in C-Reactive Protein (CRP) levels
Time frame: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of CRP levels (mg/L)
Change in fasting insulin levels
Time frame: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of fasting insulin levels (mcIU/mL) after fasting for at least 8 hours
Change in fasting glucose levels
Time frame: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of fasting glucose levels (mg/dL) after fasting for at least 8 hours
Change in lipid profile
Time frame: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol (mg/dL) after fasting for at least 8 hours
4 secondary outcomes
Change in body weight
Time frame: Baseline, 8 weeks
Change in fat mass measured by bioelectrical impedance analyzer
Time frame: Baseline, 8 weeks
Change in quality of life assessed by EORTC QLQ-C30 questionnaire
Time frame: Baseline, 8 weeks
Change in quality of life assessed by OP scale questionnaire
Time frame: Baseline, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Derived from this study: PubMed 35845810Cho AR, Hong KW, Kwon YJ, Choi JE, Lee HS, Kim HM, Bae SJ, Ahn SG, Jeong J, Lee JW. Effects of Single Nucleotide Polymorphisms and Mediterranean Diet in Overweight or Obese Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: A Pilot Randomized Controlled Trial. Front Nutr. 2022 Jul 1;9:882717. doi: 10.3389/fnut.2022.882717. eCollection 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet in people with Breast Cancer and Obesity, run by Gangnam Severance Hospital.
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 9 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: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 in C-Reactive Protein (CRP) levels (time frame: Baseline, 8 weeks). The study lists 4 primary outcomes in all. 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 NCT04045392, 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 5 Aug 2019.