the aim if this study is evaluating efficacy of scalp cooling cap in prevention of alopecia secondary to cancer chemotherapy .
Design
The current study is a clinical trail including 60 patients under treatment with one of special chemotherapy regimes which have well known total alopecia.
Settings and conduct
in one arm 30 patients use cooling cap from 30 minute before to 2 hours after every course of chemotherapy . In another arm 30 patients undergo the same chemotherapy regimens without using cooling cap
Participants/Inclusion and exclusion criteria
Include Criteria: Consent for using the cap and filling on the questionnaire; using chemotherapy regimens resulting in total alopecia in patient with Breast cancer, gonadal malignancies and soft tissue sarcomas; performance higher than 70%; age between 18 to 75 years.
ٍExcluding Criteria: melanoma; blood malignancies; liver or kidney dysfunction; migraine ; history of cryoglobulinemia; systemic lupus erythematosus ; no consent for using the caps.
Intervention groups
using scalp cooling cap in patient with Breast cancer, gonadal malignancies and soft tissue sarcoma with chemotherapy regimens resulting in total alopecia.
Main outcome variables
Alopecia
General information
Reason for update
Acronym
Mashhad Scalp Cooling Caps
IRCT registration information
IRCT registration number:IRCT20141102019783N4
Registration date:2019-01-13, 1397/10/23
Registration timing:registered_while_recruiting
Last update:2019-01-13, 1397/10/23
Update count:0
Registration date
2019-01-13, 1397/10/23
Registrant information
Name
Mitra Fazl Ersi
Name of organization / entity
Mashhad University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 1516
Email address
fazlm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of using scalp cooling caps in prevention of chemotherapy-induced alopecia
Public title
Efficacy of using scalp cooling caps in prevention of chemotherapy-induced alopecia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
consent for using the cap and filling on the questionnaire
using chemotherapy regimens resulting in total alopecia including: 1. Doxorobicin plus cyclophosphamide followed by one of the Taxane drugs (in one, two or three-week regimens) 2. BEP regimen in gonadal malignanciy 3. FEC (5Fu-Epirubicin -cyclophosphamaid) regimen 4. VAC (vincristin-Doxorobicin -cyclophosphamaid) regimen in sarcomas
performance higher than 70%
age between 18 to 75 years
Exclusion criteria:
Melanoma
Blood malignancies
Liver or kidney dysfunction
Migraine
History of cryoglobulinemia
Systemic lupus erythematosus
No consent for using the caps
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
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
Regional Ethics Committee of Mashhad University of Medical Sciences
Street address
Goreishi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
345 91357
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.MUMS.fm.REC.1394.415
Health conditions studied
1
Description of health condition studied
Breast malignancy
ICD-10 code
CD50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
alopecia
Timepoint
prior to each chemotherapy cycle
Method of measurement
visual inspection and questionnaire based on WHO alopecia grading
Secondary outcomes
1
Description
headache
Timepoint
following every cycle of chemotherapy
Method of measurement
qestionnaire
Intervention groups
1
Description
Using Scalp Cooling Cap 30 minutes before, during and up to 2.5 hours after chemotherapy with "Adriamycin and Cyclophosphamide" in breast cancer.
Category
Other
2
Description
Using Scalp Cooling Cap 30 minutes before, during and up to 1.5 hours after chemotherapy with "Paclitaxel 175 mg/m2" in breast cancer.
Category
Treatment - Drugs
3
Description
Using Scalp Cooling Cap 30 minutes before, during and up to 1 hour after chemotherapy with "Paclitaxel 80 mg/m2" in breast cancer
Category
Treatment - Drugs
4
Description
Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Bleomycin - Etoposide - Cisplatin" in gonadal malignancy.
Category
Treatment - Drugs
5
Description
Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Epirubicin - Cyclophosphamide - Fluorouracil (5Fu)" in breast cancer.
Category
Treatment - Drugs
6
Description
Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Vincristine - Adriamycin - Cyclophosphamide" in soft tissue sarcoma.
Category
Treatment - Drugs
7
Description
Chemotherapy with "Adriamycin and Cyclophosphamide" in breast cancer without using scalp cooling cap.
Category
Treatment - Drugs
8
Description
Chemotherapy with "Paclitaxel 175 mg/m2" in breast cancer without using scalp cooling cap.
Category
Treatment - Drugs
9
Description
Chemotherapy with "Paclitaxel 80 mg/m2" in breast cancer without using scalp cooling cap.
Category
Treatment - Drugs
10
Description
Chemotherapy with "Bleomycin - Etoposide - Cisplatin" in gonadal malignancy without using scalp cooling cap.
Category
Treatment - Drugs
11
Description
Chemotherapy with "Epirubicin - Cyclophosphamide - Fluorouracil (5Fu)" in breast cancer without using scalp cooling cap
Category
Treatment - Drugs
12
Description
Chemotherapy with "Vincristine - Adriamycin - Cyclophosphamide" in soft tissue sarcoma without using scalp cooling cap.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Mitra Fazl Ersi
Street address
Alandasht Sq., Koohsangi St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
mitrafazlersi@gmail.com
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Mitra Fazl Ersi
Street address
Emam Reza Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
mitrafazlersi@gmail.com
3
Recruitment center
Name of recruitment center
Hasheminejad hospital
Full name of responsible person
Mitra Fazl Ersi
Street address
Abureyhan Street, Mofatteh Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9155788869
Phone
+98 51 3273 7011
Email
mitrafazlersi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Marjan Ardakanian
Street address
Daneshgah Street, Ghoreishi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3843 3363
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mitra Fazl Ersi
Position
Radiation Oncologist
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Alandasht Sq., Koohsangi St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Fax
Email
mitrafazlersi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roham Salek
Position
Professor (in Radiotherapy & Oncology)
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Alandasht Sq., Koohsangi St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Fax
Email
salekr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mitra Fazl Ersi
Position
Radiation Oncologist
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Alandasht Sq., Koohsangi St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Fax
Email
mitrafazlersi@gmail.com
Web page address
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