The proposed study will evaluate a Ginkgo biloba intervention (compared to placebo) on female sexual function. In this double-blind, randomized, placebo-controlled trial, 60 women, with hormone-receptor-negative breast cancer who had undergone breast cancer surgery will be enrolled. Any participant who consume anticoagulant agents, psychopharmacological drugs or have any serious medical conditions, and not having sex at least twice during the study period will be excluded. Women will randomly, using a computer-generated code, assign to receive Ginkgo biloba or placebo for 8-weeks. The intervention group will receive a pill of Ginkgo biloba (40 mg), three times a day for 2 weeks. Participants who tolerate the pills will receive them at a dose of 80 mg three times a day for the remainder of the study. The control group will receive pills of placebo, following the same regimen as the Ginkgo biloba group. The score of Female Sexual Function Index (FSFI) would be the primary outcome measure that will be assessed before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012414477N3
Registration date:2016-03-09, 1394/12/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Zhila Taherzadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
taherzadehzh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-10-14, 1395/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of Ginkgo biloba on sexual dysfunction in women with breast cancer compared with placebo
Public title
The Effect of Ginkgo biloba on sexual dysfunction in patients with breast cancer;
A randomized double blind placebo – controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being married;18 years of age or older; At least 2 month after the end of treatment; Signed and dated written informed consent prior to admission to the study;The ability to speak; understand the Persian; Patients who had undergone breast cancer surgery
Exclusion criteria:
not having sex at least twice during the study period; Having any other medical; conditions such as:
cardiovascular diseases ( i.e. uncontrolled hypertension, history of infarction, deep-vein thrombosis), Pulmonary diseases (i.e. asthma, shortness of breath), Neurological diseases ( i.e. convulsions, epilepsy, migraine, cerebrovascular disorder), History of bleeding disorder, kidney diseases, liver diseases, endocrine disorders (i.e. diabetes), mental disorders, coagulation disorders; Other malignancies other than breast cancer; Infertility; Stressful event (other than cancer) during the last 6 months (e.g. traumatic and stressful event, changes in living conditions such as relocation, financial ruin, marital problems, losing a close family member); Failing to follow the treatment plan; A history of psychiatric disorder; Patients taking SSRI 2 weeks prior to study; Anticoagulant therapy (Heparin, enoxaparin, warfarin, clopidogrel, ticlopidine) 2 weeks prior to study; Patients with hormone-receptor (HR)-positive breast cancer.
Age
From 18 years old to 80 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Committee for Research Ethics, Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.MUMS.REC.1394.577
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
c50
ICD-10 code description
Family history of malignant neoplasm of breast
Primary outcomes
1
Description
Female Sexual Function Index score
Timepoint
Before and after intervention
Method of measurement
Female Sexual Function Index scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive a pill of Ginkgo biloba (40 mg), three times a day for 2 weeks. Participants who tolerate the pills will receive them at a dose of 80 mg three times a day for the remainder of the study
Category
Treatment - Drugs
2
Description
The control group will receive pills of placebo that look like Ginkgo biloba tablet, following the same regimen as the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Fatemeh Homaee Shandiz
Street address
Emam Reza Square, Ebne Sina Avenue
City
Mashhad
2
Recruitment center
Name of recruitment center
Ghaem Educational, Research and Treatment Center
Full name of responsible person
Fatemeh Homaee Shandiz
Street address
Dr. Shariati Square, beginning of Ahmadabad Avenue
City
Mashhad
3
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Azar Fani Pakdel
Street address
Alandasht Square, Koohsangi Avenue
City
Mashhad
4
Recruitment center
Name of recruitment center
Reza Radiotherapy Oncology Center (RROC)
Full name of responsible person
Azar Fani Pakdel
Street address
Fallahi 2, Ghasemabad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr. Mohsen Tafaghodi (Research Deputy of Mashhad University of Medical Sciences)
Street address
University St., Ghoraishy Building
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice chancellor for research
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
Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Fatemeh Homaee Shandiz
Position
Associate Professor
Other areas of specialty/work
Street address
Omid Hospital, Alandash Square, Koohsangi Avenue
City
Mashhad
Postal code
Phone
+98 51 3842 6082
Fax
Email
HomaeeF@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cancer Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Azar Fani Pakdel
Position
Assistant Professor
Other areas of specialty/work
Street address
Omid Hospital, Alandash Square, Koohsangi Avenue
City
Mashhad
Postal code
Phone
+98 51 3842 6082
Fax
Email
FaniPA@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Azar Fani Pakdel
Position
Assistant Professor
Other areas of specialty/work
Street address
Omid Hospital, Alandash Square, Koohsangi Avenue
City
Mashhad
Postal code
Phone
+98 51 3842 6082
Fax
Email
FaniPA@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)