Protocol summary

Study aim
Determining the effect of a vaginal product containing Cucurbita pepo L. subsp. pepo fruit (green zucchini morphotype) on subjective symptoms of vulvovaginal atrophy in women with breast cancer
Design
Clinical trial with control group; Parallel groups; Double-blind; Randomized; Phase 3 on 60 patients; Block Randomization will be used for random allocation.
Settings and conduct
Place of study: Radiotherapy Oncology Clinic of Shohadaye Tajrish Hospital, Tehran; Study population: Women with breast cancer complaining of subjective symptoms of vulvovaginal atrophy; Type of blinding: double blind; How to blind: Using the same packaging and the same color for both products.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with breast cancer in the age range of 18 to 50 years; History of chemotherapy, radiotherapy or hormonal treatment due to breast cancer; Complaining of subjective symptoms of vulvovaginal atrophy; Positive estrogen and/or progesterone receptor; Exclusion criteria: Menstruation during the last 6 months; History of other cancers and subsequent chemotherapy and radiotherapy; Presence of metastasis
Intervention groups
Intervention group: treatment with Cucurbita pepo L. subsp. pepo fruit vaginal cream, The medication should be used one applicator (equivalent to 5 grams) every other night in the first two weeks of intervention and then two nights a week in the following two weeks. Control group: treatment with Vagisoft cream, The medication should be used one applicator (equivalent to 5 grams) every other night in the first two weeks of intervention and then two nights a week in the following two weeks.
Main outcome variables
Subjective symptoms of vulvovaginal atrophy; vaginal itching, burning and dryness; dyspareunia; sexual function; treatment satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230923059496N1
Registration date: 2024-04-15, 1403/01/27
Registration timing: prospective

Last update: 2024-04-15, 1403/01/27
Update count: 0
Registration date
2024-04-15, 1403/01/27
Registrant information
Name
Zahra Ahmadi Basir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 1456
Email address
z.a.basir@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of a vaginal product containing Cucurbita pepo L. subsp. pepo fruit (green zucchini morphotype) compared to Vagisoft cream on subjective symptoms of vulvovaginal atrophy in women with breast cancer
Public title
Effect of a vaginal product containing Cucurbita pepo L. subsp. pepo fruit (green zucchini morphotype) on subjective symptoms of vulvovaginal atrophy in women with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women Being at the age of 18 to 50 years With a history of estrogen receptor (ER) positive and/or progesterone receptor (PR) positive breast cancer History of chemotherapy, radiotherapy or hormonal treatment due to breast cancer At least 6 months have passed since menopause following chemotherapy, radiotherapy or hormonal treatment The participant must be in the first two years of follow-up after the completion of adjuvant treatment and at the same time, at least 6 months have passed since the completion of chemotherapy Complaining about subjective symptoms of vulvovaginal atrophy (itching, burning, dryness, dyspareunia) with a total score of at least 3 Having a negative pap smear in the last year The patient's consent to participate in the project The ability to fill out the forms and questionnaires alone or with the help of the researcher
Exclusion criteria:
Having an acute mental illness and using antidepressants in the last 4 weeks Having a history of other cancers followed by chemotherapy and radiotherapy Metastatic breast cancer An increase in vaginal secretions and having a genitourinary infection
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
It is clear that random block permutations of four can be generated in the following ways: (0, 0, 1., 1). (0, 1, 0., 1). (0., 1., 1., 0). (1., 1., 0., 0). (1, 0., 1., 0). (1, 0., 0., 1) In order to obtain a random permutation in each block, two numbers were selected by a simple random method from the numbers one to four by the software and were considered as group Zero and two unselected numbers were considered as group One. In this way, the allocation status of the participants to the intervention and control groups was determined in the order of entry into the study. Another 15 blocks of size 4 were produced in the same way. Selected codes were numbered from 1 to 60. Using a random number table for each row, a three-digit number was assigned as a drug code. Finally, the generated list was provided to the pharmacist so that the drugs and placebos could be coded accordingly. To blind the third phase, assigning code 1 to the drug or placebos was left to the pharmacist, to be decoded after data analysis is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double Blind. In this study, the vaginal product containing Cucurbita pepo L. subsp. pepo fruit is prepared in the form of cream and is packed in a tube and coded after putting a label. Vagisoft cream is also prepared with the same color and in the same packaging and coded. Therefore, until the encoding, it is not possible for the participants, principle investigator, healthcare providers, data collectors, outcome assessors, manuscript writers to distinguish the medication of the intervention group from the control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.643

Health conditions studied

1

Description of health condition studied
vulvovaginal atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis

Primary outcomes

1

Description
Subjective Symptom Score of Vulvovaginal Atrophy Based on Vulvovaginal Subjective Symptom Score Form
Timepoint
Evaluation of subjective symptoms of vulvovaginal atrophy at baseline (before intervention), 2 and 4 weeks after the intervention beginning
Method of measurement
Vulvovaginal Subjective Symptom Score Form

2

Description
Vulvovaginal Dryness Score Based on Vulvovaginal Subjective Symptom Score Form
Timepoint
Evaluation of vulvovaginal dryness at baseline (before intervention), 2 and 4 weeks after the intervention beginning
Method of measurement
Vulvovaginal Subjective Symptom Score Form

3

Description
Vulvovaginal Itching Score Based on Vulvovaginal Subjective Symptom Score Form
Timepoint
Evaluation of vulvovaginal Itching at baseline (before intervention), 2 and 4 weeks after the intervention beginning
Method of measurement
Vulvovaginal Subjective Symptom Score Form

4

Description
Vulvovaginal burning Score Based on Vulvovaginal Subjective Symptom Score Form
Timepoint
Evaluation of vulvovaginal burning at baseline (before intervention), 2 and 4 weeks after the intervention beginning
Method of measurement
Vulvovaginal Subjective Symptom Score Form

5

Description
Dyspareunia Score Based on Vulvovaginal Subjective Symptom Score Form
Timepoint
Evaluation of dyspareunia at baseline (before intervention), 2 and 4 weeks after the intervention beginning
Method of measurement
Vulvovaginal Subjective Symptom Score Form

Secondary outcomes

1

Description
Female Sexual Function Index Score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

2

Description
Sexual desire score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

3

Description
Sexual arousal score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

4

Description
Vaginal lubrication score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

5

Description
Orgasm score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

6

Description
Sexual satisfaction score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

7

Description
Sexual pain score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

8

Description
Satisfaction of treatment
Timepoint
After the Intervention completion
Method of measurement
Asking the patient

Intervention groups

1

Description
Intervention group: Use a vaginal product containing Cucurbita pepo L. subsp. pepo fruit (green zucchini morphotype), One applicator every other night for 2 weeks followed by one applicator two nights a week for 2 weeks.
Category
Treatment - Drugs

2

Description
Control group: Use Vagisoft vaginal cream, One applicator every other night for 2 weeks followed by one applicator two nights a week for 2 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Oncology Radiotherapy Clinic of Shohadaye Tajrish hospital
Full name of responsible person
Zahra Ahmadi Basir
Street address
No. 8, Shams Alley (in front of Tavanir avenue), Vali-e- Asr street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
Email
z.a.basir@sbmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
5th Floor, Building No.2 of Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Basir
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley (in front of Tavanir avenue), Vali-e- Asr street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
z.a.basir@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Basir
Position
MD,PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley (in front of Tavanir avenue), Vali-e- Asr street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
z.a.basir@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Basir
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley (in front of Tavanir avenue), Vali-e- Asr street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
0098 88773521
Email
z.a.basir@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The study has not yet started, after the study is completed a decision will be made about sharing the participants' non-identifiable personal data.
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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