Clinical trial NCT04818996: Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients
Official title: Evaluation of the Effect of Mediterranean Diet on Body Composition, Oxidant Stress and Proinflammatory Markers in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Diet therapy
Mediterranean diet
Oxidant Stress markers
Proinflammatory markers
Body Composition
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this study, it was aimed to evaluate the effect of the Mediterranean diet on body composition, oxidant stress and proinflammatory markers in overweight and obese breast cancer women.

Detailed description: Breast cancer is the most common type of cancer among women in both developed and developing countries and is the leading cause of cancer death among women worldwide. Breast cancer is a disease that can develop and progress for various reasons. In addition to unchangeable factors such as increasing age and genotype, modifiable factors such as smoking, alcohol consumption, lack of physical activity, malnutrition, and obesity play a role in the pathogenesis of the disease.

Breast cancer risk increases with increasing body mass index (BMI) in postmenopausal women. Chronic inflammation in obesity is associated with an increase in the release of proinflammatory factors (such as TNF-α, IL-1, IL-6). This situation; It is a risk factor for many types of cancer such as colon, stomach, breast and prostate carcinomas and supports a cause-effect relationship between obesity and cancer. These proinflammatory factors act as signal converters for tumor growth and progression. Obese women have elevated levels of TNF-α and IL-6 in the circulation, and this is associated with the development and progression of breast tumors.

The Mediterranean Diet, which consists of high amounts of monounsaturated fatty acids, fruits, vegetables and whole grains, has been widely evaluated and indicated as an important factor in preventing tumor formation from inflammatory pathways.

Weight loss improves the antitumor immune system, lowers estrogen levels, reduces the risk of breast cancer and has been associated with better outcomes in obese patients. Lifestyle intervention studies strongly suggest that weight loss is possible and observational studies can actually improve breast cancer survival.In this regard, a healthy lifestyle and diet are the first steps to prevent breast cancer.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old,
* BMI value to be ≥25 kg/m2,
* To be diagnosed with breast cancer stage I, II or III,
* Being a positive hormone receptor status, one of the biological subtypes of breast cancer,
* Having completed chemotherapy and / or radiotherapy treatment at least 6 months before starting the study,
* Not applying any treatment for body weight loss,
* Accepting to participate in the study,
* Perceiving disorder and not having communication problems.

Exclusion Criteria:

* Being under the age of 18 and over the age of 65,
* BMI value to be 40 kg/m2,
* Having advanced stage breast cancer (IV and V),
* Being diagnosed with cancer or metastasis in other organs,
* Being one of the biological subtypes of breast cancer, hormone receptor status being negative,
* Using antioxidant vitamin-mineral supplements,
* Using herbal supplements,
* Being pregnant or planning a pregnancy,
* To stop working after starting diet therapy.

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, 8 weeks
measure: Change in body mass indexs
timeFrame: Baseline, 8 weeks
measure: Change in fat mass measured by bioelectrical impedance analyzer
timeFrame: Baseline, 8 weeks
measure: Change in fat-free mass measured by bioelectrical impedance analyzer
timeFrame: Baseline, 8 weeks
measure: Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer
timeFrame: Baseline, 8 weeks
measure: Change in interleukin 6 (IL-6)
timeFrame: Baseline, 8 weeks
measure: Change in tumor necrosis factor alpha (TNF-α)
timeFrame: Baseline, 8 weeks
measure: Change in malondialdehyde (MDA)
timeFrame: Baseline, 8 weeks
measure: Change in total antioxidant status (TAS)
timeFrame: Baseline, 8 weeks
measure: Change in total oxidant status (TOS)
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Baseline, 8 weeks
measure: Change in hip circumference
timeFrame: Baseline, 8 weeks
measure: Change in dietary inflammatory index (DII)
timeFrame: Baseline, 8 weeks
measure: Change in oxidative stress index (OSI)
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University, Faculty of Health Sciences, Department of Nutrition and Dietetics
state: Efeler
Study officials:
affiliation: Aydın Adnan Menderes University, Faculty of Health Sciences, Department of Nutrition and Dietetics
name: Burcu Deniz Güneş
role: STUDY_CHAIR
References: