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Comparison of the effect of stellate ganglion block and paroxetine on hot flashes and sleep disturbances in breast cancer survivors

Protocol summary

Summary
Objectives: The aim of this study is finding of new modalities in treatment of symptoms of drug induced early menopause in breast cancer survivors instead of hormone replacement therapy. Design and Participants: The study is randomized, double blind, without control of placebo, as a first trial. The sampling is made from 21 to 45 y/o breast cancer survivors, who are suffering from hot flashes and their consequences, including sleep disturbances for a minimum period of 1 month, with life expectancy greater than 6 months. Patients under treatment with chemotherapy drugs, hormones, or other known treatments of menopausal symptoms, patients with coagulation abnormalities, acute infections, cardiac diseases and ASA class ≥3 are excluded. Sample size calculated based of previous studies is 40 patients who are randomized in two groups. Intervention: In the study group stellate ganglion block was done under sonographic guidance, and in the socond group, the patients received oral paroxetine for 6 weeks. Main outcomes: Times and severity of hot flashes and sleep quality in patients, were estimated before intervention, and then 2, 4 and 6 weeks after that.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100710599N13
Registration date: 2016-11-18, 1395/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of medical sciences
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of stellate ganglion block and paroxetine on hot flashes and sleep disturbances in breast cancer survivors
Public title
New therapeutic methods for drug induced early menopause in breast cancer patients instead of hormone replacement therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: symptoms suffering for a minimum period of one month, age 21 to 45 y/o, and life expectancy greater than 6 month. Exclusion criteria: patients under treatment with chemotherapy drugs, androgens, estrogens, progesterone analogs, or other known treatments of menopausal symptoms for example vitamin E, antidepressants and gabapentin, coagulation abnormalities, aspirin users, acute infections, cardiac diseases and ASA class ≥3.
Age
From 21 years old to 45 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Sciences
Street address
Tehran - Shahid Hemmat Highway
City
Tehran
Postal code
Approval date
2016-09-18, 1395/06/28
Ethics committee reference number
IR.IUMS.REC.1395.28823

Health conditions studied

1

Description of health condition studied
drug induced early menopause in breast cancer
ICD-10 code
N95 - 3
ICD-10 code description
Post-artificial-menopause syndrome

Primary outcomes

1

Description
hot flashes
Timepoint
before intervention and 2, 4 and 6 weeks after interventin
Method of measurement
Sloan and coworkers raing scale

2

Description
sleep quality
Timepoint
before intervention and 2, 4 and 6 weeks after interventin
Method of measurement
The Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

empty

Intervention groups

1

Description
Advising of oral paroxetine 7.5 mg daily for 6 weeks in control group
Category
Treatment - Drugs

2

Description
Stellate ganglion block under sonographic guidance with 10 ml of 0.5% bupivacaine in study group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat-e Rasool Hospital
Full name of responsible person
Behzad Ebrahimi MD
Street address
Sattar khan - Niayesh St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Research- Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Musavi
Street address
Shahid Hemmat Expway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research- Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behzad Ebrahimi MD
Position
Anesthesiologist - Assistant fellowship of pain
Other areas of specialty/work
Street address
Hazrat-e Rasool Hospital - Pain operating room
City
Tehran
Postal code
Phone
+98 21 6435 2107
Fax
Email
behzade49@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzade MD
Position
Anesthesilogist and Pain Fellowship - Assistant professor of Anesthesiology and Pain department
Other areas of specialty/work
Street address
Hazrat-e Rassol Hospital
City
Tehran
Postal code
Phone
+98 21 6435 2107
Fax
Email
poupak_rah@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behzad Ebrahimi MD
Position
Anesthesiologist - Assistant fellowship of Pain
Other areas of specialty/work
Street address
Hazrat-e Rasool Hospital - Pain operating room
City
Tehran
Postal code
Phone
+98 21 6435 2107
Fax
Email
behzade49@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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