Evaluation of the effect of Chamomile oil on lymphedema volume, range of motion and quality of life in breast cancer related lymphedema
Design
clinical trial-Randomized-Comparison between traditional medicine product and conventional intervention
Settings and conduct
Randomization trial for lymphedema after breast cancer by which lymphologist selected for tratment and then 3 group:1group Routinly CDT(MLD,Skin lotion,Bandajing) 2.CDT by chamomile oil(baise of olive oil) 3.CDT by olive oil
Plaise of intervention:Lymphedema clinic of Motamed Cacer instiute.Tehran,Iran
Participants/Inclusion and exclusion criteria
The inclusion criteria this trial:
-Age 35-75
-Lymphedema over volium betwin upper limb 200ml
-History Breast Cancer
-Minimum after other tretment(surgery, chemotheropy,radiotherapy)
Non entry criteres:
-Inflamaines
-CHF
-RF
-Others Cancer
-DVT
-Metastatic Cancer
Intervention groups
Coindide interventio group:
1.Rotinly CDT
2.CDT by chamomile oil(base of olive oil
3.CDT by olive oil
Main outcome variables
Volum edema upper limb, Renge of motion shoulder,Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190312043024N1
Registration date:2019-09-15, 1398/06/24
Registration timing:retrospective
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Zahra Sheikhi Mobarakeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 6001
Email address
zsheikhi@mrcjd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Chamomile oil on lymphedema volume, range of motion and quality of life in breast cancer related lymphedema
Public title
Effect of Chamomile oil in breast cancer related lymphedema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
acute/ chronic infection
CHF
RF
Lymphedema post other cancer
smoker or alchohol consumer
DVT
Metastatics patient
Age
From 35 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Research Ethics Committee.
Street address
Simay-e Iran Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1195
Health conditions studied
1
Description of health condition studied
Lymphedema
ICD-10 code
I97.2
ICD-10 code description
Postmastectomy lymphedema syndrome
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
Control group: rutin CDT(MLD+ Bandaging+Skin care)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motamed Cancer Institute
Full name of responsible person
Zahra sheikhiMobarakeh
Street address
146,South Gandi
City
Tehran
Province
Tehran
Postal code
۱۴۱۵۵۶۶۱۵
Phone
+98 21 8888 6869
Email
Zsheikhi@mrcjd.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mmotamed cancrer inistitiut
Full name of responsible person
dr ramin sarrami_foroshani
Street address
No. 146, South Gandi Ave., Vanak sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۵۵۶۶۱۵
Phone
+98 21 8888 6962
Email
dr.shaikhi88@gmil.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mmotamed cancrer inistitiut
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra SheikhiMobarakeh
Position
MD-PhD Condidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8Shams Alley_Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.shaikhi88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Zahra SheikhiMobarakhe
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
lymphology
Street address
146, South Gandi Ave.,Vanak Sq
City
Tehran
Province
Tehran
Postal code
۱۴۱۵۵۶۶۱۵
Phone
+98 21 8888 6869
Email
dr.shaikhi88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
dr zahra sheikhi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
lymphology
Street address
146, South Gandi Aven., Vanak.,
City
Tehran
Province
Tehran
Postal code
۱۴۱۵۵۶۶۱۵
Phone
+98 21 8888 6869
Email
dr.shaikhi88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publishing resultin from of PhD thesis an article indexing ISI
When the data will become available and for how long
after PhD thesis defence
To whom data/document is available
Publitic
Under which criteria data/document could be used
For Researchers
From where data/document is obtainable
Dr zahra sheikhi,Motamed Cancer Center
What processes are involved for a request to access data/document