Effects of Aromatherapy with Lavender and Peppermint Essential Oils on the symptoms of chemotherapy-induced peripheral neuropathy in patients with breast cancer
Investigating the effect of aromatherapy with lavender and peppermint essential oil on the symptoms of peripheral neuropathy caused by chemotherapy in patients with breast cancer
Design
Clinical trial with control group, with single group, non-blinded, randomized, phase 3 on 34 patients. To randomize from Excel software
Settings and conduct
Radio-oncology department of Shahada Tajrish Hospital
Patients with breast cancer who have received chemotherapy with taxanes and have neuropathy complications will receive the drug, and the extent of their complications will be re-evaluated after the period of taking the drug
Participants/Inclusion and exclusion criteria
Breast cancer patients with a history of chemotherapy with "Taxanes" who ; have symptoms of peripheral neuropathy based on specialized neurological examination and diagnosis and meet the inclusion criteria
Intervention groups
The intervention group will receive lavender and peppermint essential oil and the control group will receive a placebo (base oil) should use it to the tip of the toes) and on the hands (from the wrist to the tips of the fingers) for a period of 4 weeks
Main outcome variables
The initial level of pain, numbness, movement disorder, symptoms of peripheral neuropathy, type of chemotherapy drug, dose of chemotherapy drug, dose of lavender and peppermint essence/placebo dose, rate of neuropathy complications after using the drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230407057835N1
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Omid Khaleghpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 750 5303
Email address
omidkh21@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Aromatherapy with Lavender and Peppermint Essential Oils on the symptoms of chemotherapy-induced peripheral neuropathy in patients with breast cancer
Public title
Effects of Aromatherapy with Lavender and Peppermint Essential Oils on symptoms of chemotherapy-induced peripheral neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patient is undergoing chemotherapy or has a history of chemotherapy with" Taxanes" at most in the last 2 months
Based on the expert's diagnosis, patient has grade B peripheral neuropathy caused by ;chemotherapy based on the PNQ questionnaire;
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization by statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Behesti University of medical sciences
Street address
Simaye Iran Ave, South Falamak and Zarafshan Blv, Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.SBMU.MSP.REC.1401.458
Health conditions studied
1
Description of health condition studied
Peripheral neuropathy caused by chemotherapy with" Taxane" drugs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Peripheral neuropathy symptoms based on PNQ questionnaire
Timepoint
Measurement of peripheral neuropathy symptoms based on PNQ questionnaire 1 month after drug use
Method of measurement
PNQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Breast cancer patients with a history of chemotherapy with "Taxanes", who have symptoms of peripheral neuropathy based on neurological examination and diagnosis and meet the inclusion criteria, will receive lavender and peppermint essential oils. To the participants It is explained that the oil should be applied 2.5 cc in the morning and 2.5 cc at night before going to bed on the legs (from the ankles to the tips of the toes) and on the hands (from the wrists to the tips of the fingers) for a period of 4 weeks
Category
Rehabilitation
2
Description
Control group: Patients with breast cancer with a history of chemotherapy with "Taxanes", who have symptoms of peripheral neuropathy based on neurological examination and diagnosis and meet the criteria for entering the study, will receive the placebo. The participants will be explained. who should apply 2.5 cc of oil in the morning and 2.5 cc at night before going to bed on the legs (from the ankles to the tips of the toes) and on the hands (from the wrists to the tips of the fingers) for a period of 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
radio-oncology department of Shohada Tajrish Hospital
Full name of responsible person
Mona Malekzadeh
Street address
Shahrdari Ave, Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8081
Email
omidkh21@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Babak Shokri
Street address
next to Taleghani hospital, Tabnak Ave, Evin, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9783
Email
omidkh21@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
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
Omid Khaleghpanah
Position
radio-oncology assistant
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No 24, Alizadeh Tabrizi Ave , north Zanjan street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1455687464
Phone
+98 913 750 5303
Email
omidkh21@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mona Malekzade
Position
radio-oncologist
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Shahrdari Ave, Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8081
Email
m.malekzadeh20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Omid Khaleghpanah
Position
radio-oncology assistant
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No 24, Alizadeh Tabrizi Ave, Zanjan Shomali street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1455687464
Phone
+98 913 750 5303
Email
omidkh21@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Difficulty in accessing patients due to their general condition and their low willingness
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It will be mentioned in the text of the final thesis
When the data will become available and for how long
It will be mentioned in the text of the final thesis
To whom data/document is available
It will be mentioned in the text of the final thesis
Under which criteria data/document could be used
It will be mentioned in the text of the final thesis
From where data/document is obtainable
It will be mentioned in the text of the final thesis
What processes are involved for a request to access data/document
It will be mentioned in the text of the final thesis