Women's Health: Neoplasm of BreastNCT06307470
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors
A study testing EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) in people with Women's Health: Neoplasm of Breast and Menopause, Premature, run by University of Arkansas at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are: 1. What is the feasibility of this intervention in an online, private setting? 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Women's Health: Neoplasm of Breast, Menopause, Premature, Body Image
- What is being tested?
- EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 30 Nov 2025
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with breast cancer (stages I - III) between ages 18 - 50
- Completed active treatment (chemotherapy and/or radiation) within the last five years
- Can read/speak English
- Access to talk in quiet, safe environment for privacy
- On hormonal therapies (aromatase inhibitors, tamoxifen)
- Currently partnered (i.e., in a relationship)
Who cannot join
- Currently undergoing active treatment (chemotherapy and/or radiation)
- More than five years have passed since completing active treatment (chemotherapy and/or radiation)
- History of advanced breast cancer (stage IV) or a breast cancer recurrence
- Women without access to the internet
- Cannot read/speak in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women
The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:
- What is the feasibility of this intervention in an online, private setting?
- What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?
Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 16 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.
- Conditions
- Women's Health: Neoplasm of Breast, Menopause, Premature, Body Image, Sexual Dysfunction, Cancer, Breast
- Being tested
- EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)
- Keywords
- breast cancer, young women, cancer survivorship, sexual functioning, body image, premature menopause
- Medical subject headings
- Menopause, Premature, Sexual Dysfunction, Physiological, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)Behavioural
The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills.
The solution-focused tools will include vaginal rehydration and dilation products with vaginal lubrication. Tools will be distributed via mail by Session 2.
| Study group | Role | What they receive |
|---|---|---|
| EMBRACE Group | Experimental | Immediately following consent, participants randomized to the EMBRACE Group will begin with the EMBRACE intervention. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants.
Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150. Receives: Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) |
| Delayed EMBRACE Group | Active comparator | After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 16 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants.
Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150. Receives: Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vulvovaginal Symptoms Questionnaire (VSQ)
A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
Measured: Week 1, Week 16, Week 22
Body Image Scale
A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment.
Measured: Week 1, Week 16, Week 22
Female Sexual Functioning Index
A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.
Measured: Week 1, Week 16, Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Oct 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Women's Health: Neoplasm of BreastStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Intimate Pathways Center for Sexual Health
- Responsible party
- Sponsor
- Investigators
- Pearman D Parker, PhD, MPH, RN, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307470
- Sponsor's protocol ID
- 276879
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juraskova I, Jarvis S, Mok K, Peate M, Meiser B, Cheah BC, Mireskandari S, Friedlander M. The acceptability, feasibility, and efficacy (phase I/II study) of the OVERcome (Olive Oil, Vaginal Exercise, and MoisturizeR) intervention to improve dyspareunia and alleviate sexual problems in women with breast cancer. J Sex Med. 2013 Oct;10(10):2549-58. doi: 10.1111/jsm.12156. Epub 2013 May 1.
PubMed 23635341Wettergren L, Eriksson LE, Bergstrom C, Hedman C, Ahlgren J, Smedby KE, Hellman K, Henriksson R, Lampic C. Prevalence and risk factors for sexual dysfunction in young women following a cancer diagnosis - a population-based study. Acta Oncol. 2022 Oct;61(10):1165-1172. doi: 10.1080/0284186X.2022.2112283. Epub 2022 Sep 29.
PubMed 36176069Marsh S, Borges VF, Coons HL, Afghahi A. Sexual health after a breast cancer diagnosis in young women: clinical implications for patients and providers. Breast Cancer Res Treat. 2020 Dec;184(3):655-663. doi: 10.1007/s10549-020-05880-3. Epub 2020 Sep 23.
PubMed 32968951Rash JK, Seaborne LA, Peterson M, Kushner DM, Sobecki JN. Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. Support Care Cancer. 2023 Feb 16;31(3):171. doi: 10.1007/s00520-023-07635-4.
PubMed 36795172Esplen MJ, Wong J, Warner E, Toner B. Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial. J Clin Oncol. 2018 Mar 10;36(8):749-756. doi: 10.1200/JCO.2017.74.8244. Epub 2018 Jan 22.
PubMed 29356610Mifsud A, Pehlivan MJ, Fam P, O'Grady M, van Steensel A, Elder E, Gilchrist J, Sherman KA. Feasibility and pilot study of a brief self-compassion intervention addressing body image distress in breast cancer survivors. Health Psychol Behav Med. 2021 May 21;9(1):498-526. doi: 10.1080/21642850.2021.1929236.
PubMed 34104572Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs. 2011 Mar-Apr;34(2):142-9. doi: 10.1097/NCC.0b013e3181f1ab7a.
PubMed 20885305Panjari M, Bell RJ, Davis SR. Sexual function after breast cancer. J Sex Med. 2011 Jan;8(1):294-302. doi: 10.1111/j.1743-6109.2010.02034.x. Epub 2010 Sep 23.
PubMed 21199377Rosenberg SM, Vaz-Luis I, Gong J, Rajagopal PS, Ruddy KJ, Tamimi RM, Schapira L, Come S, Borges V, de Moor JS, Partridge AH. Employment trends in young women following a breast cancer diagnosis. Breast Cancer Res Treat. 2019 Aug;177(1):207-214. doi: 10.1007/s10549-019-05293-x. Epub 2019 May 30.
PubMed 31147983Ruddy KJ, Greaney ML, Sprunck-Harrild K, Meyer ME, Emmons KM, Partridge AH. A qualitative exploration of supports and unmet needs of diverse young women with breast cancer. J Community Support Oncol. 2015 Sep;13(9):323-9. doi: 10.12788/jcso.0169.
PubMed 26859752Vegunta S, Kuhle CL, Vencill JA, Lucas PH, Mussallem DM. Sexual Health after a Breast Cancer Diagnosis: Addressing a Forgotten Aspect of Survivorship. J Clin Med. 2022 Nov 14;11(22):6723. doi: 10.3390/jcm11226723.
PubMed 36431200Gorman JR, Drizin JH, Smith E, Flores-Sanchez Y, Harvey SM. Patient-Centered Communication to Address Young Adult Breast Cancer Survivors' Reproductive and Sexual Health Concerns. Health Commun. 2021 Nov;36(13):1743-1758. doi: 10.1080/10410236.2020.1794550. Epub 2020 Jul 23.
PubMed 32703034
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women
- ClinicalTrials.gov ID
- NCT06307470
- Acronym / sponsor ID
- 276879
- Conditions
- Women's Health: Neoplasm of Breast, Menopause, Premature, Body Image, Sexual Dysfunction, Cancer, Breast
- Keywords
- breast cancer, young women, cancer survivorship, sexual functioning, body image, premature menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Intimate Pathways Center for Sexual Health
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Mar 2024 (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.
The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:
- What is the feasibility of this intervention in an online, private setting?
- What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?
Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 16 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMBRACE Group | Experimental | Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)Immediately following consent, participants randomized to the EMBRACE Group will begin with the EMBRACE intervention. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150. |
| Delayed EMBRACE Group | Active comparator | Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 16 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed with breast cancer (stages I - III) between ages 18 - 50
- Completed active treatment (chemotherapy and/or radiation) within the last five years
- Can read/speak English
- Access to talk in quiet, safe environment for privacy
- On hormonal therapies (aromatase inhibitors, tamoxifen)
Key exclusion criteria (5 listed)
- Currently undergoing active treatment (chemotherapy and/or radiation)
- More than five years have passed since completing active treatment (chemotherapy and/or radiation)
- History of advanced breast cancer (stage IV) or a breast cancer recurrence
- Women without access to the internet
- Cannot read/speak in English
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 |
|---|---|---|
| EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills. The solution-focused tools will include vaginal rehydration and dilation products with vaginal lubrication. Tools will be distributed via mail by Session 2. | Behavioural | Delayed EMBRACE Group, EMBRACE Group |
Primary outcome
Vulvovaginal Symptoms Questionnaire (VSQ)
Time frame: Week 1, Week 16, Week 22
A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
Body Image Scale
Time frame: Week 1, Week 16, Week 22
A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment.
Female Sexual Functioning Index
Time frame: Week 1, Week 16, Week 22
A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 23635341Juraskova I, Jarvis S, Mok K, Peate M, Meiser B, Cheah BC, Mireskandari S, Friedlander M. The acceptability, feasibility, and efficacy (phase I/II study) of the OVERcome (Olive Oil, Vaginal Exercise, and MoisturizeR) intervention to improve dyspareunia and alleviate sexual problems in women with breast cancer. J Sex Med. 2013 Oct;10(10):2549-58. doi: 10.1111/jsm.12156. Epub 2013 May 1.
- Background: PubMed 36176069Wettergren L, Eriksson LE, Bergstrom C, Hedman C, Ahlgren J, Smedby KE, Hellman K, Henriksson R, Lampic C. Prevalence and risk factors for sexual dysfunction in young women following a cancer diagnosis - a population-based study. Acta Oncol. 2022 Oct;61(10):1165-1172. doi: 10.1080/0284186X.2022.2112283. Epub 2022 Sep 29.
- Background: PubMed 32968951Marsh S, Borges VF, Coons HL, Afghahi A. Sexual health after a breast cancer diagnosis in young women: clinical implications for patients and providers. Breast Cancer Res Treat. 2020 Dec;184(3):655-663. doi: 10.1007/s10549-020-05880-3. Epub 2020 Sep 23.
- Background: PubMed 36795172Rash JK, Seaborne LA, Peterson M, Kushner DM, Sobecki JN. Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. Support Care Cancer. 2023 Feb 16;31(3):171. doi: 10.1007/s00520-023-07635-4.
- Background: PubMed 29356610Esplen MJ, Wong J, Warner E, Toner B. Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial. J Clin Oncol. 2018 Mar 10;36(8):749-756. doi: 10.1200/JCO.2017.74.8244. Epub 2018 Jan 22.
- Background: PubMed 34104572Mifsud A, Pehlivan MJ, Fam P, O'Grady M, van Steensel A, Elder E, Gilchrist J, Sherman KA. Feasibility and pilot study of a brief self-compassion intervention addressing body image distress in breast cancer survivors. Health Psychol Behav Med. 2021 May 21;9(1):498-526. doi: 10.1080/21642850.2021.1929236.
- Background: PubMed 20885305Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs. 2011 Mar-Apr;34(2):142-9. doi: 10.1097/NCC.0b013e3181f1ab7a.
- Background: PubMed 21199377Panjari M, Bell RJ, Davis SR. Sexual function after breast cancer. J Sex Med. 2011 Jan;8(1):294-302. doi: 10.1111/j.1743-6109.2010.02034.x. Epub 2010 Sep 23.
- Background: PubMed 31147983Rosenberg SM, Vaz-Luis I, Gong J, Rajagopal PS, Ruddy KJ, Tamimi RM, Schapira L, Come S, Borges V, de Moor JS, Partridge AH. Employment trends in young women following a breast cancer diagnosis. Breast Cancer Res Treat. 2019 Aug;177(1):207-214. doi: 10.1007/s10549-019-05293-x. Epub 2019 May 30.
- Background: PubMed 26859752Ruddy KJ, Greaney ML, Sprunck-Harrild K, Meyer ME, Emmons KM, Partridge AH. A qualitative exploration of supports and unmet needs of diverse young women with breast cancer. J Community Support Oncol. 2015 Sep;13(9):323-9. doi: 10.12788/jcso.0169.
- Background: PubMed 36431200Vegunta S, Kuhle CL, Vencill JA, Lucas PH, Mussallem DM. Sexual Health after a Breast Cancer Diagnosis: Addressing a Forgotten Aspect of Survivorship. J Clin Med. 2022 Nov 14;11(22):6723. doi: 10.3390/jcm11226723.
- Background: PubMed 32703034Gorman JR, Drizin JH, Smith E, Flores-Sanchez Y, Harvey SM. Patient-Centered Communication to Address Young Adult Breast Cancer Survivors' Reproductive and Sexual Health Concerns. Health Commun. 2021 Nov;36(13):1743-1758. doi: 10.1080/10410236.2020.1794550. Epub 2020 Jul 23.
- Individual participant dataSharing planned: No
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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.
Pearman D Parker, PhD, MPH, RN principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) in people with Women's Health: Neoplasm of Breast and Menopause, Premature, run by University of Arkansas at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vulvovaginal Symptoms Questionnaire (VSQ) (time frame: Week 1, Week 16, Week 22). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307470, which also lists 12 linked publications.
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 26 Dec 2025.