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The effect of topical herbal oil based on lavender, Acorus calamus and Turmeric on Taxanes -induced peripheral neuropathy in cancer patients

Protocol summary

Study aim
The effect of topical herbal oil based on lavender, Acorus calamus and Turmeric on Taxanes - induced peripheral neuropathy in cancer patients and control group
Design
A controlled, double-blind, randomized, phase 2 clinical trial with parallel group, on 75 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The location is the Radio-Oncology department of Mahdieh Hospital The control group received 1 cc of placebo oil three times a day, and the intervention group received 6 cc of herbal oil on the surface of the feet and hands. Drug; glass containers with a dropper of one shape and the name of the product as a code Duration of the intervention is 4 weeks, drug test 24 hours before use
Participants/Inclusion and exclusion criteria
A 4-week double-blind randomized clinical trial of 74 volunteer patients, 18-80 years of age, patients with breast, gynecological and urological cancer inTehran Mahdieh Hospital, with peripheral neuropathy, response to treatment, assessment of improvement in the scores of the NPS, the FACT/GOG-Ntx, PNQ scale by a physician
Intervention groups
Entry criteria • Having cancer with a pathological answer • undergoing chemotherapy or completed chemotherapy within the last two months • Patients with neuropathy, as determined by a neurologist, due to Taxanes chemotherapy • Having peripheral neuropathy of lower or upper limbs or both • Having at least Grade B neuropathy based on the PNQ questionnaire • Not having Guillain-Barre, diabetes, multiple sclerosis and carpal tunnel syndrome • Age 18 - 80 • Willingness to collaborate on the project • Insensitivity to herbal medicines • Stage 1 to 3 patients • No amputations or no wounds on hands and feet • Not having skin cancer • no concurrent radiotherapy
Main outcome variables
Sensory and motor disorders of upper and lower limbs, neuropathic pain, symptoms of neuropathy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240306061184N1
Registration date: 2025-04-23, 1404/02/03
Registration timing: registered_while_recruiting

Last update: 2025-04-23, 1404/02/03
Update count: 0
Registration date
2025-04-23, 1404/02/03
Registrant information
Name
Mehri Sadeghi Khansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7782 4506
Email address
dr.msadeghi4431@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical herbal oil based on lavender, Acorus calamus and Turmeric on Taxanes -induced peripheral neuropathy in cancer patients
Public title
The effect of topical herbal oil based on lavender, Acorus calamus and Turmeric on Taxanes -induced peripheral neuropathy in cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast, gynecological and urology cancer in the age range of 18-80 years with complaints of peripheral neuropathy symptoms, according to the opinion of a neurologist; their neuropathy is due to chemotherapy with taxane drugs. Are undergoing chemotherapy or have a history of chemotherapy, provided that no more than two months have passed since the completion of their chemotherapy, regardless of the number of chemotherapy courses.
Exclusion criteria:
Having diabetes and other neuropathies such as Guillain-Barré, multiple sclerosis, and carpal tunnel syndrome Allergy to herbal medicines Stage 4 cancer patients Patients who perform radiotherapy at the same time as chemotherapy
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 74
More than 1 sample in each individual
Number of samples in each individual: 37
37 people in the intervention group (herbal oil based on lavender, Acorus calamus and Turmeric) and 37 people in the control group (baby oil)
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are placed in two groups of test and control by block randomization method According to the sample size, we will have 9 blocks of 8 people and 1 block of 2 people. In each block, half of the lottery papers will correspond to "I" or intervention and the rest will be "p" or placebo. The medicine and placebo containers will be identical and they will be identified only based on a code that identifies which medicine and which is placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor and the patient are not aware of the type of treatment (placebo or herbal product) assigned either before or after the treatment. In other words, the patient does not know which group he will be placed in and does not know whether the drug he received is the main drug under study or not. On the other hand, the doctor examining the effect of the drug should not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran university of Medical Sciences
Street address
Traditional and Complementary Medicine Research Center, Khazar Blvd, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2024-02-28, 1402/12/09
Ethics committee reference number
IR.MAZUMS.REC.1402.665

Health conditions studied

1

Description of health condition studied
Taxanes-induced peripheral neuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy

Primary outcomes

1

Description
Sensory and motor disorders and pain and symptoms of neuropathy in the lower and upper limbs
Timepoint
The beginning of the study (before the start of the intervention) and 28 days after the start of topical herbal oil consumption (the end of the intervention)
Method of measurement
To quantitatively evaluate peripheral neuropathy before and after intervention(Questionnaire FACT/GOG-Ntx Version 4)Functional Assessment of Cancer Therapy for patients with neurotoxicity questionnaire - version 4 (FACT-GOG-NTX), Qualitative symptoms of peripheral neuropathy based on the scalePNQ (Patient Neurotoxicity Questionnaire), Pain before and after the intervention; Neuropathic Pain Scale (NPS)

Secondary outcomes

1

Description
Registration of possible complications
Timepoint
While studying
Method of measurement
Side effects registration form

Intervention groups

1

Description
Intervention group: In the test group, the participants are asked to apply 1 cc of oil (vegetable) on the surface of the foot (from the ankle to the tip of the toes) and the surface of the hand (from the wrist to the tip of the fingers) three times a day. spread, a total of 6 cc daily.
Category
Treatment - Drugs

2

Description
Control group: In the control group, the participants are asked to apply 1 cc of oil (placebo) on the surface of the foot (from the ankle to the tip of the toes) and the surface of the hand (from the wrist to the tip of the fingers) three times a day. spread, a total of 6 cc daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Radiotherapy-Oncology, Mahdieh Hospital (Tehran)
Full name of responsible person
Masoumeh Keshvari
Street address
Department of Radiotherapy-Oncology, Mahdieh Hospital, Rajab Niya St, Shush Square, Tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
me.sadeghi@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Mazandaran University of Medical Sciences
Street address
Traditional and Complementary Medicine Research Center, Khazar Blvd, next to Baghban Medical Complex (Toubi), Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3324 4893
Email
tcmrcmazums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Yosofpoor
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Research Center,Khazar Blvd, next to Baghban Medical Complex (Toubi), Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3324 4893
Email
m.yousefpour@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad yosofpoor
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Research Center,Khazar Blvd, next to Baghban Medical Complex (Toubi), Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3324 4893
Email
m.yousefpour@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehri Sadeghi Khansari
Position
PhD student of Iranian Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
NO#8, Shams AVE, Valiasr St, Faculty of Traditional Medicine, Shahid Beheshti University
City
Tehran
Province
Tehran
Postal code
۱۵۱۶۷۴۵۸۱۱
Phone
+98 21 8877 3521
Fax
+98 21 8877 6027
Email
me.sadeghi@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcome and secondary outcome
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
dr.msadeghi4431@gmail.com Dr. Mehri Sadeghi Khansari
What processes are involved for a request to access data/document
A maximum time is one month
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