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Investigation the effect of oral Rosemary hydro-alchohlic extract on chemotherapy induced peripheral neuropathy in the patients with metastatic gastrointestinal malignancy: A randomized clinical trial

Protocol summary

Study aim
Determining the effect of oral Rosemary hydro-alcoholic extract on chemotherapy induced peripheral neuropathy in patients with metastatic gastrointestinal cancer
Design
This study is a double-blind randomized controlled clinical trial in which 52 patients are randomly assigned to one of two intervention and control (placebo) groups. In order to equalize the distribution of the important confounders of gender, age and type of cancer, classes based on these variables are classified, and then they are placed in 2 study groups in a balanced way by block randomization.
Settings and conduct
Patients referring Shahid Rahimi Hospital for chemotherapy are included in the study after giving written informed consent. Considering that the contents of the capsules are known only to the main researcher and other people are unaware of its contents. Therefore, both investigators, patients, medical staffs and data analysts are blinded in this study.
Participants/Inclusion and exclusion criteria
Patients with metastatic gastrointestinal cancer, age over 25 years, consent to participate in the study and receive chemotherapy containing oxaliplatin Non-entry Criteria: patients with significant kidney and liver function impairment
Intervention groups
In this study, patients will be randomly assigned to one of two intervention or control groups. In the intervention group, patients are given 500 mg capsules containing rosemary extract and the patient is asked to consume three capsules a day for two months. In the control group, placebo will be given.
Main outcome variables
The main outcomes including degree of peripheral neuropathy, intensity of neuropathic pain, tendon reflex, feeling of tremors, murmuring, numbness, quality of life, sensory-motor function of the patient and cognitive impairment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200331046902N1
Registration date: 2023-02-07, 1401/11/18
Registration timing: registered_while_recruiting

Last update: 2023-02-07, 1401/11/18
Update count: 0
Registration date
2023-02-07, 1401/11/18
Registrant information
Name
Shahram Ahmadi Somaghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3331 4711
Email address
shahrama20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-05, 1401/11/16
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of oral Rosemary hydro-alchohlic extract on chemotherapy induced peripheral neuropathy in the patients with metastatic gastrointestinal malignancy: A randomized clinical trial
Public title
Investigation the effect of oral Rosemary extract on chemotherapy induced peripheral neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with metastatic gastrointestinal cancers aged 25 to 80 years undergoing chemotherapy with oxaliplatin-containing chemotherapy regimens.
Exclusion criteria:
Patients who have previously received a chemotherapy regimen containing neurotoxic drugs and now have peripheral neuropathy. Patients receiving other neurotoxic drugs (such as some HIV drugs) at the same time as chemotherapy. Patients with a history of diabetes mellitus and peripheral neuropathy caused by nerve compression (such as carpal tunnel or tarsal syndrome, radiculopathy, spinal stenosis, brachial plexopathy) Patients who, at the same time as chemotherapy, start taking drugs that reduce neuropathy symptoms (such as SNRI drugs) and pain relievers such as acetaminophen, pregabalin, and NSIDs, or change their amount during treatment. Patients with psychological disorders such as: severe depression, patients with suicidal thoughts, bipolar diseases Patients who consume alcohol. Patients with significant impairment of liver and kidney tests Patients who do not agree to consume rosemary extract or do not agree to participate in the study in any way. The patient is unable to tolerate rosemary extract during the study.
Age
From 25 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study is a non-probability sequential method based on including and excluding criteria and until the completion of the sample volume. Allocation of samples in study groups is done by random block method. Random allocation: in order to equalize the distribution of the important confounders of gender, age and type of cancer, classes based on these variables are as follows: male class/female class, age less than 60 years/over 60 years and cancer of the esophagus, cardia, stomach, pancreas, gall bladder , small intestine, large intestine, sigmoid, rectal and anal are created and then they are placed in 2 study groups in a balanced way by block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, after meeting the including criteria's and completing the informed consent form, the patients will be randomly assigned to one of two groups A or B, and based on this grouping, the patient will be given either A or B can. Can A contains 500 mg capsules of medicine (rosemary extract) and can B contains 500 mg placebo capsules (starch). Only the main researcher is aware of the contents of cans A and B, and the nurses taking the sample and assessing the outcomes, the patients, the medical staffs and the person analyzing the data are not aware of the contents of cans A and B. In case of serious complications and questions of the attending physician, the contents of the cans will be explained to them. It is explained to the patient that he may randomly receive placebo or rosemary extract, in both cases the patient will not be deprived of his usual treatments.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Lorestan University of Medical Sciences
Street address
Shahid Rahimi hospital, Azadi square, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6813816314
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.LUMS.REC.1400.001

Health conditions studied

1

Description of health condition studied
chemotherapy induced peripheral neuropathy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Chemotherapy induced peripheral neuropathy
Timepoint
At the beginning of the study, and then before the start of each chemotherapy session for up to two months.
Method of measurement
Based on the EORTC-CIPN20 questionnaire and measuring symptoms by a research expert based on the Total Neuropathy Score (TNS) scale.

2

Description
Severity of neuropathic pain based on Numerical Rating Scale tool
Timepoint
At the beginning of the study, and then before the start of each chemotherapy session for up to two months.
Method of measurement
Measurement of symptoms by an investigator based on the Numerical Rating Scale tool

Secondary outcomes

1

Description
Quality of life score
Timepoint
At the beginning of the study, and then before the start of each chemotherapy session for up to two months.
Method of measurement
Based on the EORTC QLQ-C30 questionnaire

Intervention groups

1

Description
Intervention group: In this group, patients are given cans containing 500 mg capsules and the patient is asked to take one oral capsule containing 500 mg of dried rosemary extract every 8 hours for two months from the second session of chemotherapy. Rosemary plant extract was prepared by the standard method at Razi Medicinal Plants Research Center in Khorramabad.
Category
Prevention

2

Description
Control group: In this group (placebo), the patient is asked to take a can containing 500 mg capsules three times a day for two months. 500 mg capsules in this group contain 500 mg of starch as a placebo. In both the intervention and placebo groups, the patient will not be deprived of any conventional treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rahimi hospital
Full name of responsible person
Shahram Ahmadi Somaghian
Street address
Safavi Ave, between Azadi square and Gap bridge, Shahid Rahimi hospital
City
Khorramabad
Province
Lorestan
Postal code
6813816314
Phone
+98 66 3333 6144
Fax
+98 66 3333 6151
Email
ahmadi.sha@lums.ac.ir
Web page address
http://www.rahimi.lums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram Rasoulian
Street address
Lorestan University of Medical Sciences, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Email
international@lums.ac.ir
Web page address
http://www.lums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shahram Ahmadi Somaghian
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 66, Shahid Daraei Alley, Enghelab Ave, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6816938154
Phone
+98 66 3322 2156
Email
shahrama20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Yahya Baharvand Iran Nia
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
The end of Honar-e-Haftom, Faze Yek, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6817748787
Phone
+98 66 3333 6145
Email
shahrama20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Shahram Ahmadi Somaghian
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 66, Shahid Daraei Alley, Enghelab Ave, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6816938154
Phone
+98 66 3322 2156
Email
shahrama20@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
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
All the data of this research will be shared after de-identifying people.
When the data will become available and for how long
The start of the data access period will be 6 months after the results of the data are published.
To whom data/document is available
The data of this project will be made available to all researchers and even people working in the industry upon official request.
Under which criteria data/document could be used
If the rights of the main researchers and project implementers are respected, the data of this project can be used.
From where data/document is obtainable
By e-mail to the correspondent author of the article or project manager at the following addresses: Email: shahrama20@gmail.com Mobile phone: 0098 9168608836
What processes are involved for a request to access data/document
The applicant must first email his written request specifying the purpose of using the data to the project manager, then the agreement on how to use the information and respect the rights of the main project managers must be signed by the parties. After signing the contract, the data will be available to the requester in less than a month.
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