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IRCT20190312043024N1 IRCT 2019-09-15 Mmotamed cancrer inistitiut Effect of Chamomile oil in breast cancer related lymphedema Evaluation of the effect of Chamomile oil on lymphedema volume, range of motion and quality of life in breast cancer related lymphedema 2019-02-04 anticipated 51 Complete https://irct.ir/trial/39166 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After registration of patients in the study according to the inclusion and exclusion criteria, they will be randomized to one af the treatment groups: group A: CDT, group B: CDT plus herbal oil and group C: CDT plus placebo. The simple randomization method was used for randomization in this study. The statistician will randomly start with a number of the random number table. According to the three groups of treatment in this study, if the random number was 1, 2 or 3 they will be assigned to the treatment group A and if: the random number was 4, 5 or 6 they will receive treatment of group B. Random numbers of 7, 8 or 9 will assign patients to the group C. This randomization will continue to the last patient, Blinding description: Despite the statistician, patients and the lymphotherapist will be blinded to the treatment in groups B and C. for the blinding purpose, a placebo will be used which is similar with the herbal oil in the case of color, appearance, and smell. Iymphotherapist, will have a list and when a patient comes to the clinic its name will be signed up on the list. Then the statistician will be informed by a phone call of the new patient and will randomize the patient to one of the treatment groups. The statistician will bring the oil/placebo container (which is same for bothherbal oil and placebo) and will write the name of the patient on it so the lymph therapist will be blind to the treatment group. 3 Lymphedema. Intervention 1: Intervention group: CDT by Chamomile oil base of olive. CDT is the conventional management for lymphedema which includes maneuvers, bandaging, skincare and education of patient on these procedures. Before the bandaging, the lymphedematous limb should be washed with children lotion (firooz) but at this intervention herbal oil will be used. 75 ccs for each lymphedematous limb. Bandages are Germany products (AtaTeb Novin). The herbal oil was produced by pharmacists in the Department of Traditional Medicine, School of Traditional Medicine, University of Shahid Beheshti. The intervention period is 21 sessions and will be performed continuously except on Thursdays and Fridays. Intervention 2: Intervention: CDT plus placebo (base oil of olive) Same as the previous intervention, except in this group only olive oil will be used before the bandaging. Intervention 3: Control group: rutin CDT(MLD+ Bandaging+Skin care). Yes - There is a plan to make this available What will be shared: Publishing resultin from of PhD thesis an article indexing ISI When: after PhD thesis defence To whom: ‌Publitic Conditions: For Researchers Where to obtain: Dr zahra sheikhi,Motamed Cancer Center How to obtain: Approving by responsible officer Comments:
public Zahra SheikhiMobarakeh
No.8Shams Alley_Vali-e-Asr Street
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 dr.shaikhi88@gmail.com Shahid Beheshti University of Medical Sciences scientific Zahra SheikhiMobarakhe
146, South Gandi Ave.,Vanak Sq
Tehran Iran (Islamic Republic of) ۱۴۱۵۵۶۶۱۵ +98 21 8888 6869 dr.shaikhi88@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) Lymphedema with overvolume of 200 mililiter between two uper limbs history of breast cancer At least one month after last chemotherapy/radiotherpy and surgery Informed consent 35 years 75 years Female acute/ chronic infection CHF RF Lymphedema post other cancer smoker or alchohol consumer DVT Metastatics patient I97.2 Postmastectomy lymphedema syndrome Treatment - Drugs Treatment - Drugs Treatment - Other Intervention group: CDT by Chamomile oil base of olive. CDT is the conventional management for lymphedema which includes maneuvers, bandaging, skincare and education of patient on these procedures. Before the bandaging, the lymphedematous limb should be washed with children lotion (firooz) but at this intervention herbal oil will be used. 75 ccs for each lymphedematous limb. Bandages are Germany products (AtaTeb Novin). The herbal oil was produced by pharmacists in the Department of Traditional Medicine, School of Traditional Medicine, University of Shahid Beheshti. The intervention period is 21 sessions and will be performed continuously except on Thursdays and Fridays. Intervention: CDT plus placebo (base oil of olive) Same as the previous intervention, except in this group only olive oil will be used before the bandaging. Control group: rutin CDT(MLD+ Bandaging+Skin care) Lymphedema volume-RoM( renge of motion). Timepoint: setion 0(befor treatment)-7-14-21 and 1month after treatment. Method of measurement: measuring using water displacement by cylinder and Goniometr. Qouality of life. Timepoint: setion 0(befor treatment)- setion21(aftet treatment) and 1month after treatment. Method of measurement: Short form health survey(SF 36) Quesionary. Mmotamed cancrer inistitiut Approved 2019-02-03 National Research Ethics Committee. Simay-e Iran Ave Tehran Tehran Iran (Islamic Republic of)