Comparative study of vitamin D vaginal suppository and oral administration on vaginal symptoms in women with breast cancer
| ISRCTN | ISRCTN33082642 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33082642 |
| Secondary identifying numbers | 0707 |
- Submission date
- 17/01/2024
- Registration date
- 18/01/2024
- Last edited
- 06/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
A breast cancer survivor treated with aromatase inhibitor or antiestrogen to prevent recurrent disease often has a higher likelihood of experiencing genitourinary symptoms than the normal population. Current treatment options include the use of low-dose vaginal estrogen, which has data suggesting minimal systemic absorption. However, there is an effort to explore non-hormonal treatments. It has been observed that vitamin D, which has receptors in the vaginal canal, plays a role in epithelial proliferation and can reduce symptoms of genitourinary syndrome of menopause (GSM) by enhancing superficial cell growth. This study compares the effectiveness of oral administration of vitamin D versus vaginal suppositories as a treatment option in a group of breast cancer survivors with GSM symptoms.
Who can participate?
Female breast cancer survivors aged between 20 and 80 years old who are menopausal and have bothersome vaginal symptoms
What does the study involve?
To compare the effectiveness of oral administration of vitamin D versus vaginal suppositories as a treatment option in a group of breast cancer survivors with GSM symptoms, a study was conducted on breast cancer survivors receiving care at Srinagarind Hospital, Thailand. Participants will be monitored for 12 weeks by the primary researcher.
What are the possible benefits and risks of participating?
The benefits that participants will receive include receiving the treatment option of a vitamin D suppository for treating GSM symptoms and benefiting from the per-vaginal examinations of VMI, VHI, and vaginal pH, which can screen for gynecologic disease and cervical cancer simultaneously. The potential risks of treatment include vitamin D and calcium intoxication and vitamin D allergy. The researcher has a protocol for monitoring these conditions through interviews and side effect assessments one week after taking the medication, approved by the ethics committee.
Where is the study run from?
Khon Kaen University (Thailand)
When is the study starting and how long is it expected to run for?
May 2023 to April 2024
Who is funding the study?
1. Investigator initiated and funded
2. Khon Kaen University (Thailand)
Who is the main contact?
Miss. Suppakan Preetikul, MD, suppakanpreetikul@gmail.com.
Contact information
Public, Scientific, Principal Investigator
Faculty of Medicine Khon Kaen University
Khon Kaen
40000
Thailand
| Phone | +66 0897160707 |
|---|---|
| suppakanpreetikul@gmail.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Telephone |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effects of vaginal VS oral administration of Vitamin D on vulvovaginal symptoms in breast cancer survivors: a randomized clinical trial |
| Study hypothesis | There is no significant difference in the effectiveness of Vitamin D vaginal suppositories compared to oral administration in addressing vaginal symptoms among postmenopausal women with breast cancer undergoing treatment with aromatase inhibitors or GnRH agonists. |
| Ethics approval(s) |
Approved 30/05/2023, Center for Ethics in Human Research, Khon Kaen University, Faculty of Medicine (17th floor, Sor Vor 1 building, Mittraphap road, Nai Muang Subdistrict, Muang District, Khon Kaen, 40002, Thailand; +66 043-366621-3; eckku@kku.ac.th), ref: HE661059 |
| Condition | Vitamin D treatment for genitourinary syndrome of menopause (GSM) symptoms in postmenopausal women with breast cancer |
| Intervention | Postmenopausal women, aged 20-80 years old, diagnosed with breast cancer and treated with aromatase inhibitors or GnRH agonists for more than 12 weeks, who present with bothersome vaginal symptoms (defined as the Visual Analog Scores >= 4 scores by interview) and vitamin D insufficiency (defined as the serum total vitamin D < 30 ng/ml) will be recruited. Eligible participants are randomized into two groups. Randomly generated treatment allocations are placed within sealed opaque envelopes. Once a patient has consented to enter a trial an envelope is opened and the patient is then offered the allocated treatment regimen. The control group will receive vaginal vitamin D suppositories while the intervention group are administrated vitamin D orally. Each group are given vitamin D 0.25 mcg daily for 12 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Bioequivalence |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Calcitriol |
| Primary outcome measure | Bothersome vaginal symptoms of GSM measured using a visual analog scale (VAS) at baseline, 6, and 12 weeks |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline and 12 weeks: 1. Vaginal health index (VHI) measured using a vaginal health index (VHI) score 2. Vaginal Maturation Index measured using a vaginal maturation index (VMI) score 3. Vaginal pH measured using pH paper 4. Serum vitamin D level measured using blood specimen analyzed by electrochemiluminescence binding assay |
| Overall study start date | 01/05/2023 |
| Overall study end date | 20/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 80 Years |
| Sex | Female |
| Target number of participants | 76 |
| Total final enrolment | 76 |
| Participant inclusion criteria | 1. Breast cancer 2. Treated with aromatase inhibitors or GnRH agonists for longer than 12 weeks 3. Aged 20-80 years old 4. Menopause (defined as no menstruation in the past 12 months) 5. Presented with most bothersome vaginal symptoms (defined as the visual analog scores >= 4 scores by interview) 6. Serum total vitamin D < 30 ng/ml 7. Willing to participate with signed informed consent |
| Participant exclusion criteria | 1. History of hormonal use or vitamin D supplement within 12 weeks 2. Recurrent breast cancer 3. History of procedure or vaginal product use within 12 weeks 4. History of vulvovaginal infection within 12 weeks 5. History of abnormal PAP smear 6. History of vitamin D allergy 7. History of intestinal disease 8. Active hepatic disease 9. Impair renal function (GFR < 60 ml/min/1.73m2) 10. Refused to participate |
| Recruitment start date | 01/06/2023 |
| Recruitment end date | 30/01/2024 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Mittraphap road, Nai Muang Subdistrict, Muang District
Khon Kaen
40000
Thailand
Sponsor information
University/education
Mittraphap Road, Nai Muang Subdistrict, Muang District
Khon Kaen
40000
Thailand
| Phone | +66-43-009700,+66-43-002539 |
|---|---|
| info@kku.ac.th | |
| Website | https://kku.ac.th/ |
"ROR" |
https://ror.org/03cq4gr50 |
Funders
Funder type
Other
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- Khon Kaen University in Thailand, มหาวิทยาลัยขอนแก่น, KKU
- Location
- Thailand
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in high-impact peer-review journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Ms Suppakan Preetikul at suppakanpreetikul@gmail.com. Clinical data related to baseline characteristics and primary/secondary outcomes will be shared from around August 2024. Informed consent documents were obtained from participants who requested interviews, blood draws, and per-vaginal examinations, approved by the ethics committee. The information provided cannot disclose the identity of the patients. Privacy protection is in place, and patient identity cannot be disclosed. |
Editorial Notes
06/06/2025: The intention to publish date was changed from 31/07/2024 to 31/07/2025.
20/05/2024: The scientific title was changed from 'Comparative study of vitamin D vaginal suppository and oral administration on vaginal symptoms in woman with breast cancer; a randomized clinical trial' to 'Effects of vaginal VS oral administration of Vitamin D on vulvovaginal symptoms in breast cancer survivors: a randomized clinical trial'.
10/05/2024: The recruitment start date was changed from 20/01/2024 to 01/06/2023.
10/05/2024: Total final enrolment added. The intention to publish date was changed from 31/05/2024 to 31/07/2024.
07/03/2024: The Sponsor's email address and telephone number were corrected.
18/01/2024: Study's existence confirmed by the Center for Ethics in Human Research, Khon Kaen University (Thailand).
