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Impact of topical garlic oil on chemotherapy-induced peripheral neuropathy

Protocol summary

Study aim
To evaluate and compare the effect of topical garlic oil on chemotherapy-induced peripheral neuropathy
Design
A double-blind, parallel-group randomized clinical trial of 66 patients, using block randomization.
Settings and conduct
This clinical trial will be conducted on 66 cancer patients experiencing neuropathy symptoms following chemotherapy, in the Radiation Therapy Department of Vasei Hospital, Sabzevar University of Medical Sciences. Participants will be randomly divided into two groups: the intervention group, receiving topical garlic oil, and the control group, receiving a placebo (paraffin). To ensure blinding of the participants, healthcare personnel and researcher, the garlic oil and placebo will be delivered in identical, coded packages. Pain intensity and patient performance will be assessed using the BPI-SF questionnaire, while neuropathy severity will be evaluated using the EORTC QLQ-CIPN20 standard questionnaire at baseline, at the end of each week and after 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cancer patients with neuropathy, following chemotherapy, approved by the oncologist, and a pain score greater than 1 based on the McGill Pain Questionnaire-2 and the use of one of the chemotherapy regimens that cause neuropathy Exclusion criteria: Neuropathy with other causes; allergy to garlic oil or a placebo
Intervention groups
In the intervention group, 1 cc of garlic oil is applied to the soles of the feet and the backs of the hands and feet, from the wrist to the fingertips, twice daily for 6 weeks. The placebo group receives an identical treatment using the placebo.
Main outcome variables
Pain intensity and functional performance; neuropathy severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240713062420N1
Registration date: 2024-09-26, 1403/07/05
Registration timing: prospective

Last update: 2024-09-26, 1403/07/05
Update count: 0
Registration date
2024-09-26, 1403/07/05
Registrant information
Name
Shamim Shahrestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 1144
Email address
shahrestani.s14@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2024-10-31, 1403/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of topical garlic oil on chemotherapy-induced peripheral neuropathy
Public title
Impact of garlic oil on chemotherapy-induced peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer patients with neuropathy, following chemotherapy, approved by the oncologist, and a pain score greater than 1 based on the McGill Pain Questionnaire-2 (SF-MPQ-2). The use of one of the following chemotherapy regimens that cause neuropathy, including taxane group drugs in weekly, 2-week, or 3-week regimens, such as the AC-Taxol, TCH, TC, or TAC regimens.
Exclusion criteria:
Diagnosis of depression, peripheral vascular disease Use of other drugs effective in treating neuropathy, such as gabapentin, pregabalin, or duloxetine diabetes or alcohol abuse Pregnancy or breastfeeding Severe underlying condition Allergy to garlic oil or a placebo
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the specified inclusion criteria, we will perform sampling, followed by random assignment to control and intervention groups using block randomization(AABB, ABAB, ABBA, BABA, BAAB, BBAA) determined by rolling a die. To align the blocks with the numbers on the die, we assign codes 1 to 6 to each of these quaternary blocks. Code 1 corresponds to the AABB block, code 2 to the ABAB block, code 3 to the ABBA block, code 4 to the BABA block, code 5 to the BBAA block, and code 6 to the BAAB block. Since our research requires a sample size of 66 individuals, we will roll the die 17 times (4 * 17 = 68) to ensure that at least 66 samples are included. When matching the die’s outcome to the code associated with the blocks, the letter ‘A’ designates samples placed in the intervention group, while the letter ‘B’ designates samples placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, healthcare personnel and researcher are blinded to the garlic oil and placebo (paraffin). To maintain blinding, both the garlic oil and placebo (paraffin) will be provided in identical, coded packaging. It is important to note that the garlic oil closely resembles the paraffin placebo in terms of consistency, appearance, and even odor, as well as the packaging used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohidshahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618637548
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.MEDSAB.REC.1403.009

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C80.1
ICD-10 code description
Malignant (primary) neoplasm, unspecified

2

Description of health condition studied
Chemotherapy induced peripheral neuropathy (CIPN)
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy

Primary outcomes

1

Description
Pain intensity
Timepoint
At baseline, at the end of each week and at the end of the sixth week
Method of measurement
Brief Pain Inventory - Short form (BPI-SF) questionnaire

2

Description
functional performance
Timepoint
At baseline, at the end of each week and at the end of the sixth week
Method of measurement
Brief Pain Inventory - Short form (BPI-SF) questionnaire

3

Description
neuropathy severity
Timepoint
At baseline, at the end of each week and at the end of the sixth week
Method of measurement
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire—Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, 1 cc of garlic oil is applied twice daily for 6 weeks to the soles of the feet and the backs of the hands and feet, from the wrists to the fingertips. The garlic oil is sourced from Toba Tala Sabz Pharmaceutical Company.
Category
Treatment - Drugs

2

Description
Control group: In the intervention group, 1 cc of garlic oil is applied twice daily for 6 weeks to the soles of the feet and the backs of the hands and feet, from the wrists to the fingertips.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Dr. Fereshteh Ghorat
Street address
Vasei hospital., Tohid Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Fax
+98 51 4465 3861
Email
waseehospital@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Kazem Hassanpor
Street address
Sabzevar university of medical sciences, Asadabadi St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8101
Fax
+98 51 4401 8102
Email
vc.Research@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Shamim Shahrestani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 6, Besat St, Motaharri St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618637548
Phone
+98 51 4464 1144
Fax
Email
shahrestani.s14@medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sabzevar University of medical sciences, TohidShahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8363
Email
drghorat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Shamim Shahrestani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Motahari St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618637548
Phone
+98 51 4464 1144
Fax
Email
shahrestani.s14@medsab.ac.ir

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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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