lymphedema. Breast, unspecified
Conditions
Interventions
Treatment - Drugs
Placebo
Sponsors
Vice chancellor of research, Iran University of Medical Science
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: women with unilateral breast cancer related lymphedema ; breast cancer lymphedema in stage 2; Age range between 18 to 60 years ; BMI between 25 to 35 Kg/m2 ; At least one month has passed since the last treatment such as radiotherapy; Willingness to participate in the study ; Non-inclusion criteria: Use of multivitamin minerals and omega 3 supplements up to 1 month before the study began; Inflammatory diseases such as heart failure, pulmonary, kidney and diabetes; autoimmune diseases such as rheumatoid arthritis; Acute and chronic infection; taking Probiotics supplementation from 6 months before study; having a weight loss diet in Length 6 months before the study ; Smoking and Alcohol consumption; Lymphedema due to other cancers; Exclusion criteria: Cancer recurrence during the study; Metastasis; Diseases leading to edema such as renal, cardiopulmonary and pulmonary failure during the study; Infectious diseases during the study; Consumption of food and supplements containing probiotics during the study; Failure to follow the weight loss diet; Consumption less than 56 capsules; Unwillingness to continue cooperation
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor necrosis factor alpha. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin 1. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA.;Interleukin 6. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA.;Leptin. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA.;HsCRP. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: immunoturbidimetry.;Volume of lymphedema. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: water tank technique.;BMI. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: Weight ratio (kg) to squared height (m).;Waist circumference. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: meter.;Waist to hip ratio. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: Calculate.;Skinfold thickness. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: caliper.;Nutritional status. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer.;Physical Activity. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: IPAQ questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mitra Zarrati
Iran University of Medical Science
Outcome results
None listed