An interventional study of Hyaluronic acid (HLA) Vaginal Moisturizer and Polycarbophil Vaginal Moisturizer in Breast Cancer, Vulvovaginal Signs and Symptoms and Sexual Desire Disorder, sponsored by The University of Tennessee, Knoxville. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by The University of Tennessee, Knoxville · Not applicable, Interventional, and Supportive care
The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 18 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The University of Tennessee, Knoxville is the lead sponsor of 95 studies on the registry; 6 are open to participants now.
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Responds "yes" to at least one of the following questions:
Exclusion Criteria:
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.
Device: Hyaluronic acid (HLA) Vaginal Moisturizer · Behavioral: Hypnotic Relaxation
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.
Device: Hyaluronic acid (HLA) Vaginal Moisturizer · Behavioral: Progressive Muscle Relaxation (PMR)
Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8.
Device: Hyaluronic acid (HLA) Vaginal Moisturizer
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.
Device: Polycarbophil Vaginal Moisturizer · Behavioral: Hypnotic Relaxation
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.
Device: Polycarbophil Vaginal Moisturizer · Behavioral: Progressive Muscle Relaxation (PMR)
Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8.
Device: Polycarbophil Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Use of vaginal moisturizer every 3 days for weeks 1-8.
Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
Listen to PMR audio file at least 3x/week for weeks 3-8.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Consent through study completion, an average of 8 weeks.
Exploratory Outcome, Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) is a 19-item scale that measures the following domains of female sexual functioning, followed by subscale score ranges: desire (1.2-6), arousal (0-6), satisfaction (0.8-6), orgasm (0-6), lubrication (0-6) and pain (0-6). When the scores of these domains are added together, the sum represents an FSFI total score. The possible total score from 2-36 where higher scores indicate better sexual function.
Time frame: Consent through study completion, an average of 8 weeks.
Exploratory Outcome, PROMIS Sexual Function and Satisfaction (SFS)
The PROMIS scale is a 25 item measure that includes screener items. This study will include items asking about interest in sexual activity, lubrication, vaginal discomfort, vulvar discomfort, clitoral discomfort, orgasm and pleasure, and satisfaction. Raw scores must be converted to t-scores where the mean(standard deviation) = 50(10) in the referent population. Higher scores indicate more of the thing being described.
Time frame: Consent through study completion, an average of 8 weeks.
Exploratory Outcome, Breast Impact of Treatment Scale (BITS)
The BITS scale is a 13-item measure of body change stress in women with breast cancer. Possible scores range from 0-65 where higher scores indicate greater body change stress.
Time frame: Consent through study completion, an average of 8 weeks.
Exploratory Outcome, Sexual Distress Scale-Short Form (SDS-SF)
The SDS-SF is a 5-item scale that was developed based on the longer FSDS-R (Female Sexual Distress Scale, Revised). It is used to measure negative feelings like worry and frustration that people have about their sex lives and relationships. Possible scores range from 0-20. Higher scores indicate more of the thing being described.
Time frame: Consent through study completion, an average of 8 weeks.
Exploratory Outcome, Scale of Body Connection (SBC)
The SBC is a 20-item scale that measures two dimensions of body connection, body awareness (BSC-BA) measured with 12 items and bodily dissociation (SBC-BD) measured with 8 items. Possible scores for body awareness range from 0-48. Possible scores for the body dissociation range from 0-32. Higher scores indicate more of the thing being described.
Time frame: Consent through study completion, an average of 8 weeks.
Plan to share: 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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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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The University of Tennessee, Knoxville