Hormone Receptor-positive Breast CancerNCT05651087
Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient
A study testing LACUDY in people with Hormone Receptor-positive Breast Cancer, run by Gun Oh Chong.
Trial summary
Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Hormone Receptor-positive Breast Cancer
- What is being tested?
- LACUDY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Aged 20 to 60 years diagnosed with breast cancer
- Receiving anti-hormonal therapy
- Patients who subjectively complain of vaginal dryness
- Patients without current psychiatric problems
- Patients who can understand and respond to the contents of the questionnaire
- Ability to provide informed consent
Who cannot join
- Women under 19 and over 61
- Pregnant woman
- In case of recurrence or disease progression
- Patients without sexual experience
- Unable to provide informed consent
About this study
Official title: A Randomized Prospective Clinical Trial to Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment Among Breast Cancer Survivals Who Receive Anti-estrogen Therapy
Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.
Read the detailed description
- Registered subjects are 1:1 randomized using a random sequencing generator (www.random.org). Experimental group with 30 patients and Control group with 30 patinets.
- In the case of the experimental group, LACUDY 2mL is inserted twice a week for a month before going to bed for 4 weeks.
- Unpack the product and take it out.
- Remove the cap by turning it.
- Fit the nozzle to the end of the syringe and turn it to combine.
- Hold the syringe with the nozzle facing the vulva, insert it about 5-6 cm into the vagina, and then slowly press the tip of the push rod with patient's thumb to inject all the liquid in the syringe into the vagina.
- Slowly remove the syringe as the nozzle opens.
- It is recommended to wear a pad as the injected solution may flow out.
- In the case of the control group, they go about their daily lives without any treatment.
- Both the experimental group and the control group are instructed not to administer intravaginal suppositories or other drugs related to vaginal atrophy and sexual function improvement.
- A total of 2 questionnaires were conducted before and after treatment.
- Conditions
- Hormone Receptor-positive Breast Cancer
- Being tested
- LACUDY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACUDYDrug
Also called IC-LC02S2Q2
LACUDY:Insert 2mL twice a week for 4 weeks before going to bed
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Breast cancer patient who treated with LACUD Receives: Drug: LACUDY |
| Observation | No intervention | Breast cancer patient who does not treated with LACUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Vaginal health index
Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B)
Measured: Prior to administration, 1 month after LacuD treatment(2 times in total)
Secondary outcomes (1)
Vaginal microbiome
Take one cervicovaginal swab sample each
Measured: Prior to administration, 1 month after LacuD treatment(2 times in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gun Oh Chong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gun Oh Chong, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651087
- Sponsor's protocol ID
- LACUDY
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Clinical Trial to Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment Among Breast Cancer Survivals Who Receive Anti-estrogen Therapy
- ClinicalTrials.gov ID
- NCT05651087
- Acronym / sponsor ID
- LACUDY
- Conditions
- Hormone Receptor-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gun Oh ChongUniversity, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.
Detailed description
- Registered subjects are 1:1 randomized using a random sequencing generator (www.random.org). Experimental group with 30 patients and Control group with 30 patinets.
- In the case of the experimental group, LACUDY 2mL is inserted twice a week for a month before going to bed for 4 weeks.
- Unpack the product and take it out.
- Remove the cap by turning it.
- Fit the nozzle to the end of the syringe and turn it to combine.
- Hold the syringe with the nozzle facing the vulva, insert it about 5-6 cm into the vagina, and then slowly press the tip of the push rod with patient's thumb to inject all the liquid in the syringe into the vagina.
- Slowly remove the syringe as the nozzle opens.
- It is recommended to wear a pad as the injected solution may flow out.
- In the case of the control group, they go about their daily lives without any treatment.
- Both the experimental group and the control group are instructed not to administer intravaginal suppositories or other drugs related to vaginal atrophy and sexual function improvement.
- A total of 2 questionnaires were conducted before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: LACUDYBreast cancer patient who treated with LACUD |
| Observation | No intervention | –Breast cancer patient who does not treated with LACUD |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- Aged 20 to 60 years diagnosed with breast cancer
- Receiving anti-hormonal therapy
- Patients who subjectively complain of vaginal dryness
- Patients without current psychiatric problems
Key exclusion criteria (5 listed)
- Women under 19 and over 61
- Pregnant woman
- In case of recurrence or disease progression
- Patients without sexual experience
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LACUDYAlso: IC-LC02S2Q2LACUDY:Insert 2mL twice a week for 4 weeks before going to bed | Drug | Experimental |
Primary outcome
Change of Vaginal health index
Time frame: Prior to administration, 1 month after LacuD treatment(2 times in total)
Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B)
1 secondary outcome
Vaginal microbiome
Time frame: Prior to administration, 1 month after LacuD treatment(2 times in total)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LACUDY in people with Hormone Receptor-positive Breast Cancer, run by Gun Oh Chong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Vaginal health index (time frame: Prior to administration, 1 month after LacuD treatment(2 times in total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.