Protocol summary

Study aim
To determine the effectiveness of henna in preventing neuropathy caused by chemotherapy with taxane drugs in patients with cancer treated with chemotherapy regimens.
Design
A randomized, non-blinded, controlled and parallel group clinical trial was conducted on 50 patients using a randomized permutation block design.
Settings and conduct
Cancer patients who are candidates for taxane therapy and who refer to Arak Khansari Hospital will be included in the study if they are eligible. They will be randomly assigned to the intervention and control groups using a randomized block design. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cancer patients treated with taxane-containing chemotherapy regimens receiving their first course of chemotherapy, Patients with no previous proven neuropathy. Exclusion criteria: Patients' lack of cooperation, Presence of sensitivity or allergic reaction to henna.
Intervention groups
Intervention group: Patients who receive Taxane every 3 weeks for 6 chemotherapy courses. After each chemotherapy course, they apply a 50-gram package of henna from Atabak Yazd Company on the palms of their hands and feet and leave it on for 8 hours. Control group: Patients who receive Taxane every 3 weeks for 6 chemotherapy courses and do not use any alternative treatment to prevent peripheral neuropathy.
Main outcome variables
Score of NCI-CTCAE, EORTC QLQ-CIPN20 and NPSI questionnaires, Nerve conduction velocity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250607066102N1
Registration date: 2025-07-07, 1404/04/16
Registration timing: registered_while_recruiting

Last update: 2025-07-07, 1404/04/16
Update count: 0
Registration date
2025-07-07, 1404/04/16
Registrant information
Name
Sahar Rahzani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3328 7413
Email address
saharrahzani79@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-12, 1404/03/22
Expected recruitment end date
2026-06-12, 1405/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of henna in preventing neuropathy caused by chemotherapy with taxane drugs in cancer patients treated with chemotherapy regimens
Public title
Studying the effect of henna on preventing chemotherapy-induced neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with cancer who receive taxane chemotherapy drugs. All patients receiving taxanes who are receiving their first course of chemotherapy. Patients should not have previous proven neuropathy. Patients should not have proven diabetes. Patients should not have neurological damage such as Parkinson's, stroke, seizures, etc. They should not have swelling in their hands or feet. Do not have open wounds on your hands or feet.
Exclusion criteria:
Having an allergy or allergic reaction to henna Lack of cooperation from patients
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the random permutation block method will be used for randomization. For this purpose, a block of 6 will be used. In each block, three cards will be written with the letter I (Intervention) and three cards with the letter P (Placebo). To hide the cards, they will be placed in an envelope and turned over several times so that their order is not clear. As each participant enters, a card will be selected for him and the selected card will be set aside. This will be done for the next five patients until 6 people are identified. Then, randomization will be done in the same way for the other groups of 6 people to achieve the desired sample size. Some of the selected random blocks of 6 are as follows: PIPIIP, PPIPII, IPPIIP, PIPIPI, IPPIIP, IPIIPP, PIIIPP, IPPIIP, PIIPPI, PPIPII, LPLLPP, LLPLPP, IPPIIP (For example, the random assignment in the 6-patient block PIPIIP is as follows: the first patient is randomly assigned to treatment P, the second patient is randomly assigned to treatment I, the third patient is randomly assigned to treatment P, the fourth patient is randomly assigned to treatment I, the fifth patient is randomly assigned to treatment I, and the sixth patient is randomly assigned to treatment P.)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
University of Medical Sciences, Basij Square, Sardasht neighborhood, arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2025-05-18, 1404/02/28
Ethics committee reference number
IR.ARAKMU.REC.1404.072

Health conditions studied

1

Description of health condition studied
Chemotherapy-induced peripheral neuropathy
ICD-10 code
G13.0
ICD-10 code description
Paraneoplastic neuromyopathy and neuropathy

Primary outcomes

1

Description
Chemotherapy-induced peripheral neuropathy score of European organization for research and treatment of cancer Quality of Live questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) questionnaire
Timepoint
3 weeks after intervention
Method of measurement
EORTC QLQ-CIPN20 questionnaire

2

Description
Chemotherapy-induced peripheral neuropathy score from the Neuropathic Pain Symptom Inventory (NPSI) questionnaire
Timepoint
3 weeks after intervention
Method of measurement
NPSI questionnaire

3

Description
Chemotherapy-induced peripheral neuropathy score on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) questionnaire
Timepoint
3 weeks after intervention
Method of measurement
NCI-CTCAE questionnaire

4

Description
Nerve conduction velocity (NCV)
Timepoint
Before the intervention and 3 weeks after the last intervention
Method of measurement
NCV device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Henna purchased from Atabak Company, Yazd, Iran, is made into 50-gram packets and given to patients, which is mixed with lukewarm water and applied to their hands and feet for 8 hours after each chemotherapy course, which is done every 3 weeks, and 6 chemotherapy courses are done. (Henna is used once every 3 weeks.)
Category
Prevention

2

Description
Control group: Do not receive any intervention to reduce chemotherapy-induced peripheral neuropathy.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khansari Hospital
Full name of responsible person
Sahar rahzani
Street address
Ayatollah Khansari Hospital, End of Daneshgah Street
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
info_khansari@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Behzad Khansari Nejad
Street address
University of Medical Sciences, Basij Square, Sardasht neighborhood, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3383 8319
Email
behzad.khansarinejad@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Sahar Rahzani
Position
General medicine student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
34,Sedaghat Alley, Kishani Alley, Ayatollah Ghaffari ave
City
Arak
Province
Markazi
Postal code
3817718734
Phone
+98 86 3328 7413
Email
saharrahzani79@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Homa Razavi Dehkordi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
34,Sedaghat Alley, Kishani Alley, Ayatollah Ghaffari ave
City
Arak
Province
Markazi
Postal code
3817718734
Phone
+98 86 3328 7413
Email
homa.razavi84@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sahar Rahzani
Position
General medicine student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
34,Sedaghat Alley, Kishani Alley, Ayatollah Ghaffari ave
City
Arak
Province
Markazi
Postal code
3817718734
Phone
+98 86 3328 7413
Email
saharrahzani79@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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