1. Home
  2. Approved trials
  3. » فارسی

Evaluation of employing hypothermia for prevention of chemotherapy-induced peripheral neuropathy (CIPN)

Protocol summary

Study aim
Determining the effect of hypothermia on the frequency and severity of peripheral neuropathy caused by chemotherapy drugs
Design
A controlled, parallel-group, unblinded, randomized, phase 2 clinical trial of 60 patients. A table of random numbers will be used for randomization.
Settings and conduct
This study will be conducted in the Chemotherapy Center of Vasei Hospital in Sabzevar. Due to the nature of the study, it was not possible to blind the patients, the treating physician and the person investigating the evaluated outcomes to the group that the patient will be included in.
Participants/Inclusion and exclusion criteria
The study population includes breast cancer patients. Entry criteria included Consenting to use the cooling device and completing the consent form, using one of the chemotherapy regimens containing drugs associated with peripheral neuropathy, appropriate performance level, age greater than 18 years and less than 75 years, and exclusion criteria including a history of melanoma. He had a history of cryoglobulinemia, systemic lupus erythematosus, and poorly controlled diabetes. Also, patients will be excluded from the study if they do not tolerate hypothermia and withdraw their consent.
Intervention groups
In the intervention group, patients will use cold gloves and slippers during chemotherapy.
Main outcome variables
Using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) chemotherapy induced peripheral neuropathy (CIPN) 20, the severity of neuropathy was measured at the beginning of the study (before the start of the intervention) and session 6 and 12 chemotherapy and 3 months after completion of treatment will be done.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231108059991N1
Registration date: 2023-12-28, 1402/10/07
Registration timing: prospective

Last update: 2023-12-28, 1402/10/07
Update count: 0
Registration date
2023-12-28, 1402/10/07
Registrant information
Name
Fateme Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 786 8871
Email address
fatemeasadi495@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of employing hypothermia for prevention of chemotherapy-induced peripheral neuropathy (CIPN)
Public title
Determining the effect of hypothermia in improving peripheral neuropathy caused by chemotherapy drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to use the cooling device and complete the consent form The use of one of the chemotherapy regimens with the occurrence of neuropathy including drugs from the taxanes Performance more than 70% Age less than 75 years
Exclusion criteria:
History of melanoma History of systemic lupus erythematosus Poor controlled diabetes Dissatisfaction with using the device History of cryoglobulinemia
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
According to the sample size of the present study, the random allocation of the intervention in two groups will be done with the permutation block method.
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 Sabzevar University of Medical Sciences
Street address
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2023-11-07, 1402/08/16
Ethics committee reference number
IR.MEDSAB.REC.1402.074

Health conditions studied

1

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

Primary outcomes

1

Description
Severity of neuropathy
Timepoint
Measuring the severity of neuropathy at the beginning of the study (before the start of the intervention) and the 6th and 12th sessions of chemotherapy and 3 months after the end of the treatment.
Method of measurement
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20

2

Description
Quality of Life
Timepoint
Measuring the severity of neuropathy at the beginning of the study (before the start of the intervention) and 3 months after the end of the treatment.
Method of measurement
World Health Organization Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group from the time of commencing chemotherapy (or simultaneously with premedication), during the time of receiving the chemotherapy and 15 minutes after it will use the foot wrap and hand wrap connected to the cooling unit for both hands and/or feet. The device continuously maintains the surface temperature of hands and feet in the range of 3 to 5 degrees Celsius.
Category
Treatment - Devices

2

Description
Control group: Patients in this group will not use any foot wrap and hand wrap during chemotherapy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Educational and Medical Center
Full name of responsible person
Seyed Alireza Javadinia
Street address
Vasei hospital , Shohadaye Hasteii Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
javadinia.alireza@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kaze Hasanpour
Street address
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8319
Email
drhassanpour@yahoo.com
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
Seyed Alireza Javadinia
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Vasei hospital , Shohadaye Hasteii Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
javadinia.alireza@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Alireza Javadinia
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Vasei hospital , Shohadaye Hasteii Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
javadinia.alireza@mail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Alireza Javadinia
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Vasei hospital , Shohadaye Hasteii Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
javadinia.alireza@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
Not applicable
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
Loading...