Breast CancerNCT07023822
WISH, Feasibility of a Factorial Design
A study testing Hyaluronic acid (HLA) Vaginal Moisturizer, Polycarbophil Vaginal Moisturizer and Hypnotic Relaxation in people with Breast Cancer and Vulvovaginal Signs and Symptoms, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, Vulvovaginal Signs and Symptoms, Sexual Desire Disorder
- What is being tested?
- Hyaluronic acid (HLA) Vaginal Moisturizer, Polycarbophil Vaginal Moisturizer and Hypnotic Relaxation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 19 Dec 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 female
- Ability to read and write English
- History of any stage of breast cancer
- Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. Participants may use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
- Able to engage in sexual activity including penetration or insertion into the vagina
- Currently has a sexual partner.
Show all 10Show fewer
- Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or discomfort/pain with sexual activity?"
- Responds "yes" to at least one of the following questions:
- "Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or
- "Have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?"
Who cannot join
- Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change.
- An active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, PTSD, schizophrenia or borderline personality disorder (Defined per medical history and/or patient self-report)
- Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
- Previous participant in WISH Study
- Currently receiving active treatment
- Use of oral, transdermal or vaginal estrogen
- Allergy or intolerance to Replens, Hyalo Gyn or any of their components.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee, College of Nursing
Knoxville, Tennessee, 37996
About this study
Official title: Women's Interventions for Sexual Health: WISH, Feasibility of a Factorial Design
The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.
Read the detailed description
This proposal builds upon a multi-component pilot study (WISH), where women with a history of breast cancer participated in a two-component intervention to improve vulvovaginal atrophy with a vaginal moisturizer and sexual desire and body image with Hypnotic Relaxation (HR), a mind-body intervention that includes suggestions for relaxation, improved sexual desire, and body image delivered via audio file. This study seeks to further test WISH by expanding vulvovaginal atrophy interventions to include either a polycarbophil-based vaginal moisturizer (Replens™) or a hyaluronic acid-based moisturizer (HYALO GYN ®); and hypnosis relaxation (HR) or progressive muscle relaxation (PMR) interventions for sexual desire and body image. The primary outcome is the feasibility of a multi-component intervention for sexual function using a factorial design.
- Being tested
- Hyaluronic acid (HLA) Vaginal Moisturizer, Polycarbophil Vaginal Moisturizer, Hypnotic Relaxation, Progressive Muscle Relaxation (PMR)
- Keywords
- vulvovaginal atrophy, libido, hypnosis, progressive muscle relaxation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid (HLA) Vaginal MoisturizerDevice
Use of vaginal moisturizer every 3 days for weeks 1-8.
Polycarbophil Vaginal MoisturizerDevice
Use of vaginal moisturizer every 3 days for weeks 1-8.
Hypnotic RelaxationBehavioural
Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
Progressive Muscle Relaxation (PMR)Behavioural
Listen to PMR audio file at least 3x/week for weeks 3-8.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis | Experimental | Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8.
Participants will listen to hypnotic relaxation audio files at least 3x/week, weeks 3-8. There are 3 audio files in total, each about 20 min in length. The files are listened to in order. Each file is used for 2 weeks. Receives: Device: Hyaluronic acid (HLA) Vaginal Moisturizer; Behavioral: Hypnotic Relaxation |
| Hyaluronic acid (HLA) Vaginal Moisturizer + PMR | Experimental | Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8.
Participants will listen to a progressive muscle relaxation (PMR) audio file at least 3x/week, weeks 3-8. There is only 1 PMR audio file. The same file will be used for 6 weeks. Receives: Device: Hyaluronic acid (HLA) Vaginal Moisturizer; Behavioral: Progressive Muscle Relaxation (PMR) |
| Hyaluronic acid (HLA) Vaginal Moisturizer Only | Experimental | Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. Receives: Device: Hyaluronic acid (HLA) Vaginal Moisturizer |
| Polycarbophil Vaginal Moisturizer + Hypnosis | Experimental | Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8.
Participants will listen to hypnotic relaxation audio files at least 3x/week, weeks 3-8. There are 3 audio files in total, each about 20 min in length. The files are listened to in order. Each file is used for 2 weeks. Receives: Device: Polycarbophil Vaginal Moisturizer; Behavioral: Hypnotic Relaxation |
| Polycarbophil Vaginal Moisturizer + PMR | Experimental | Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8.
Participants will listen to a progressive muscle relaxation (PMR) audio file at least 3x/week, weeks 3-8. There is only 1 PMR audio file. The same file will be used for 6 weeks. Receives: Device: Polycarbophil Vaginal Moisturizer; Behavioral: Progressive Muscle Relaxation (PMR) |
| Polycarbophil Vaginal Moisturizer Only | Experimental | Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8. Receives: Device: Polycarbophil Vaginal Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Rate
The number of women who consented to participate in the study divided by the number who were eligible and educated about the study.
Measured: Screening to consent, up to 30 days.
Retention Rate
The number of women who complete all 8 weeks of the study and complete the PROMIS SFS at baseline and at eight weeks divided by the number who are randomized and begin study treatment.
Measured: Consent through study completion, an average of 8 weeks.
Adherence Rate, Moisturizer
The number of moisturizer uses completed by participants divided by the total number of possible moisturizer uses.
Measured: Consent through study completion, an average of 8 weeks.
Adherence Rate, Relaxation Intervention
The number of times participant listened to assigned relaxation audio file (hypnosis or PMR) divided by the total number of possible listens.
Measured: Consent through study completion, an average of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 Jun 2025
- Primary completion3 Oct 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a feasibility of a factorial design testing a multi-component intervention to improve vulvovaginal atrophy, sexual desire and body image. The investigators will also explore effect sizes of the chosen outcome measures to gather preliminary efficacy data.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Noel M Arrign, DNP, PhD, RN, Principal investigator, College of Nursing, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023822
- Sponsor's protocol ID
- UTK IRB-25-08813-XP
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a small pilot study and as such, data will be thoroughly interrogated. However, if a researcher feels there are unanswered questions or wishes to add to a larger dataset, the investigator would entertain all data-sharing requests for deidentified data as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Interventions for Sexual Health: WISH, Feasibility of a Factorial Design
- ClinicalTrials.gov ID
- NCT07023822
- Acronym / sponsor ID
- UTK IRB-25-08813-XP
- Keywords
- vulvovaginal atrophy, libido, hypnosis, progressive muscle relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 17 Jun 2025 (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 primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.
Detailed description
This proposal builds upon a multi-component pilot study (WISH), where women with a history of breast cancer participated in a two-component intervention to improve vulvovaginal atrophy with a vaginal moisturizer and sexual desire and body image with Hypnotic Relaxation (HR), a mind-body intervention that includes suggestions for relaxation, improved sexual desire, and body image delivered via audio file. This study seeks to further test WISH by expanding vulvovaginal atrophy interventions to include either a polycarbophil-based vaginal moisturizer (Replens™) or a hyaluronic acid-based moisturizer (HYALO GYN ®); and hypnosis relaxation (HR) or progressive muscle relaxation (PMR) interventions for sexual desire and body image. The primary outcome is the feasibility of a multi-component intervention for sexual function using a factorial design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is a feasibility of a factorial design testing a multi-component intervention to improve vulvovaginal atrophy, sexual desire and body image. The investigators will also explore effect sizes of the chosen outcome measures to gather preliminary efficacy data.
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis | Experimental | Device: Hyaluronic acid (HLA) Vaginal Moisturizer, Behavioral: Hypnotic RelaxationParticipants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to hypnotic relaxation audio files at least 3x/week, weeks 3-8. There are 3 audio files in total, each about 20 min in length. The files are listened to in order. Each file is used for 2 weeks. |
| Hyaluronic acid (HLA) Vaginal Moisturizer + PMR | Experimental | Device: Hyaluronic acid (HLA) Vaginal Moisturizer, Behavioral: Progressive Muscle Relaxation (PMR)Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to a progressive muscle relaxation (PMR) audio file at least 3x/week, weeks 3-8. There is only 1 PMR audio file. The same file will be used for 6 weeks. |
| Hyaluronic acid (HLA) Vaginal Moisturizer Only | Experimental | Device: Hyaluronic acid (HLA) Vaginal MoisturizerParticipants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. |
| Polycarbophil Vaginal Moisturizer + Hypnosis | Experimental | Device: Polycarbophil Vaginal Moisturizer, Behavioral: Hypnotic RelaxationParticipants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to hypnotic relaxation audio files at least 3x/week, weeks 3-8. There are 3 audio files in total, each about 20 min in length. The files are listened to in order. Each file is used for 2 weeks. |
| Polycarbophil Vaginal Moisturizer + PMR | Experimental | Device: Polycarbophil Vaginal Moisturizer, Behavioral: Progressive Muscle Relaxation (PMR)Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to a progressive muscle relaxation (PMR) audio file at least 3x/week, weeks 3-8. There is only 1 PMR audio file. The same file will be used for 6 weeks. |
| Polycarbophil Vaginal Moisturizer Only | Experimental | Device: Polycarbophil Vaginal MoisturizerParticipants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 female
- Ability to read and write English
- History of any stage of breast cancer
- Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. Participants may use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
- Able to engage in sexual activity including penetration or insertion into the vagina
Key exclusion criteria (7 listed)
- Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change.
- An active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, PTSD, schizophrenia or borderline personality disorder (Defined per medical history and/or patient self-report)
- Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
- Previous participant in WISH Study
- Currently receiving active treatment
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 |
|---|---|---|
| Hyaluronic acid (HLA) Vaginal MoisturizerUse of vaginal moisturizer every 3 days for weeks 1-8. | Device | Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis, Hyaluronic acid (HLA) Vaginal Moisturizer + PMR, Hyaluronic acid (HLA) Vaginal Moisturizer Only |
| Polycarbophil Vaginal MoisturizerUse of vaginal moisturizer every 3 days for weeks 1-8. | Device | Polycarbophil Vaginal Moisturizer + Hypnosis, Polycarbophil Vaginal Moisturizer + PMR, Polycarbophil Vaginal Moisturizer Only |
| Hypnotic RelaxationListen to hypnotic relaxation audio files at least 3x/week for weeks 3-8. | Behavioural | Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis, Polycarbophil Vaginal Moisturizer + Hypnosis |
| Progressive Muscle Relaxation (PMR)Listen to PMR audio file at least 3x/week for weeks 3-8. | Behavioural | Hyaluronic acid (HLA) Vaginal Moisturizer + PMR, Polycarbophil Vaginal Moisturizer + PMR |
Primary outcome
Accrual Rate
Time frame: Screening to consent, up to 30 days.
The number of women who consented to participate in the study divided by the number who were eligible and educated about the study.
Retention Rate
Time frame: Consent through study completion, an average of 8 weeks.
The number of women who complete all 8 weeks of the study and complete the PROMIS SFS at baseline and at eight weeks divided by the number who are randomized and begin study treatment.
Adherence Rate, Moisturizer
Time frame: Consent through study completion, an average of 8 weeks.
The number of moisturizer uses completed by participants divided by the total number of possible moisturizer uses.
Adherence Rate, Relaxation Intervention
Time frame: Consent through study completion, an average of 8 weeks.
The number of times participant listened to assigned relaxation audio file (hypnosis or PMR) divided by the total number of possible listens.
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 5 May 2026.
- Individual participant dataSharing planned: No. This is a small pilot study and as such, data will be thoroughly interrogated. However, if a researcher feels there are unanswered questions or wishes to add to a larger dataset, the investigator would entertain all data-sharing requests for deidentified data as appropriate.
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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.
Noel M Arrign, DNP, PhD, RN principal investigator
College of Nursing, University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid (HLA) Vaginal Moisturizer, Polycarbophil Vaginal Moisturizer and Hypnotic Relaxation in people with Breast Cancer and Vulvovaginal Signs and Symptoms, run by The University of Tennessee, Knoxville 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 10 inclusion and 7 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 5 May 2026. 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?
Accrual Rate (time frame: Screening to consent, up to 30 days.). The study lists 4 primary outcomes in all. 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 5 May 2026.