Vaginal Moisturizers and Relaxation Techniques for Vulvovaginal Symptoms

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Must not be taking: Estrogen

Disqualifiers: Active psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different vaginal moisturizers and relaxation techniques to improve sexual function in women who have had breast cancer. Participants will use either a hyaluronic acid (HLA) vaginal moisturizer or a polycarbophil vaginal moisturizer, with some groups also using relaxation audio files such as hypnosis or muscle relaxation. The trial targets women who have completed their primary cancer treatment, experience vaginal dryness or discomfort during sex, and have noticed changes in body image or sexual desire after cancer treatment. As an unphased trial, this study explores new ways to enhance sexual health and well-being after cancer treatment.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, but you cannot use oral, transdermal, or vaginal estrogen. If you're on antidepressants, you can continue them as long as you've been on a stable dose for at least 30 days before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hyaluronic acid (HLA) vaginal moisturizers are safe and effective for relieving vaginal dryness. In a clinical study, women using HLA reported less dryness and irritation, with 84% experiencing relief from dryness and 86% from itching and burning. These moisturizers generally cause no major side effects.

Polycarbophil vaginal moisturizers also demonstrate good safety results. Studies indicate they effectively reduce symptoms like dryness and discomfort quickly. Most users tolerate these moisturizers well, with few side effects reported.

Both HLA and polycarbophil moisturizers offer non-hormonal options for vaginal care, which many people find appealing. Research suggests these treatments are safe and well-tolerated for most users. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for vulvovaginal symptoms because they combine vaginal moisturizers with relaxation techniques, offering a holistic approach. Unlike standard treatments like hormonal creams or oral medications, hyaluronic acid and polycarbophil vaginal moisturizers provide non-hormonal options that can be used regularly without systemic side effects. The addition of hypnosis and progressive muscle relaxation is unique, aiming to enhance symptom relief by addressing stress and discomfort through mind-body techniques. This combined approach could lead to more comprehensive and effective management of symptoms, offering new hope for those seeking alternative solutions.

What evidence suggests that this trial's treatments could be effective for vulvovaginal symptoms?

This trial will evaluate different combinations of treatments for vulvovaginal symptoms. Research has shown that hyaluronic acid (HLA) vaginal moisturizers, which participants in some trial arms will use, can effectively improve vaginal dryness and overall vulvar health. Studies have found that these moisturizers significantly alleviate symptoms of vaginal atrophy. Polycarbophil vaginal moisturizers, another treatment option in this trial, also effectively reduce symptoms like vaginal dryness and discomfort, providing long-lasting relief. Participants in some arms will engage in hypnotic relaxation therapy, which has improved sexual function, with many positive results reported. Progressive muscle relaxation (PMR) techniques, included in other trial arms, may help by reducing stress and promoting relaxation. ^{1 2 4 5 6}

Who Is on the Research Team?

Noel M Arrign, DNP, PhD, RN

Principal Investigator

College of Nursing, University of Tennessee

Are You a Good Fit for This Trial?

This trial is for women over 18 who have had breast cancer, finished primary treatment between 3 months and 10 years ago, can engage in sexual activity, experience vaginal dryness or discomfort during sex, and have noticed a negative change in body image or sexual desire post-cancer. They must not be on certain hormone treatments or participating in other sexual health studies.

Inclusion Criteria

I am able to have sexual intercourse.

I am a woman aged 18 or older.

Ability to read and write English

Exclusion Criteria

Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed)

I am currently undergoing treatment for my condition.

I have been on a stable dose of antidepressants for at least 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Treatment

Participants use a vaginal moisturizer every 3 days and listen to relaxation audio files 3 times a week

8 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for adherence and retention after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hyaluronic acid (HLA) Vaginal Moisturizer
• Hypnotic Relaxation
• Polycarbophil Vaginal Moisturizer
• Progressive Muscle Relaxation (PMR)

Trial Overview The study tests the effectiveness of Polycarbophil and Hyaluronic acid vaginal moisturizers along with Hypnotic Relaxation and Progressive Muscle Relaxation techniques to improve sexual function. It uses a factorial design to see how these interventions work alone or combined.

How Is the Trial Designed?

Group I: Polycarbophil Vaginal Moisturizer Only Experimental Treatment 1 Intervention

Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8.

Group II: Polycarbophil Vaginal Moisturizer + PMR Experimental Treatment 2 Interventions

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.

Group III: Polycarbophil Vaginal Moisturizer + Hypnosis Experimental Treatment 2 Interventions

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.

Group IV: Hyaluronic acid (HLA) Vaginal Moisturizer Only Experimental Treatment 1 Intervention

Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8.

Group V: Hyaluronic acid (HLA) Vaginal Moisturizer + PMR Experimental Treatment 2 Interventions

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.

Group VI: Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7423634/

A Single-Arm Clinical Trial Investigating the Effectiveness ... Our findings demonstrated the vulvar health benefits of the hydrating moisturizer on both PROs and pelvic exam outcomes. Participants were highly satisfied with ...

2. journals.lww.com journals.lww.com/menopausejournal/fulltext/2024/09000/a_randomized,_pilot_trial_comparing_vaginal.4.aspx

A randomized, pilot trial comparing vaginal hyaluronic acid ... A single-arm clinical trial investigating the effectiveness of a non-hormonal, hyaluronic acid-based vaginal moisturizer in endometrial cancer survivors.

3. mcpress.mayoclinic.org mcpress.mayoclinic.org/women-health/vaginal-hyaluronic-acid-products-how-do-they-help/

Vaginal hyaluronic acid products: How do they help? It helps hydrate, locks in moisture, increases skin flexibility and even helps joints move smoothly. I recommend vaginal moisturizers with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10520994/

Comparison of the Efficacy of Vaginal Hyaluronic Acid to ... This study aimed to summarize the evidence regarding the efficacy of topical HA compared to topical estrogen in postmenopausal women with vaginal atrophy.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609515303994

Evaluation of the Efficacy and Safety of Hyaluronic Acid ... Both hyaluronic acid vaginal gel and estriol cream can significantly improve the clinical symptoms of vaginal dryness in postmenopausal women.

6. hellobonafide.com hellobonafide.com/products/revaree

Vaginal Moisturizer | Revaree A month of Revaree's hyaluronic acid can have dramatic results. In a clinical study, women experienced 84% less vaginal dryness, 86% less itching and burning, ...