Clinical trial NCT05782920: Management of Cancer Therapy Related Vulvovaginal Atrophy
Official title: Comparison Between Platelet-rich Plasma (PRP) and Hyaluronic Acid (HA) in the Treatment of Cancer-therapy Related Vulvovaginal Atrophy and Its Impact on Sexual Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 45
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to:

1. evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal atrophy.
2. To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners.

Patients will be divided randomly into 3 groups:

Group 1: 15 female patients will receive vaginal PRP injections. Group 2: 15 female patients will receive vaginal PRP injections combined with non-cross-linked hyaluronic acid.

Group 3: 15 female patients will receive topical non-cross-linked hyaluronic acid gel as a control group.

Detailed description: 1. The first group will receive two treatment of sub-mucosal PRP injection at the outer 3 cm of the vagina with one month interval in between. (17)
2. The second group will receive two treatment of PRP injection mixed with non-cross linked hyaluronic acid at the outer 3 cm of the vagina with one month interval in between.

9. 3-The third group will receive one applicator (5gm) three times per week of topical hyaluronic acid gel for vaginal application which will be prepared in the faculty of pharmacy for 2 months.

Clinical assessment Patients will be assessed for symptoms and signs of vulvovaginal atrophy (VVA) at baseline, one month, two months, and, three months after the end of treatment.

1. Vulvovaginal atrophy (VVA) symptoms (dryness, dyspareunia) will be assessed on a subjective 10-point scale.

   Also, patient satisfaction with each type of treatment will be assessed with a questionnaire at the end of treatment and they will be asked if they wish to repeat the treatment to maintain effectiveness over time (yes or No).
2. For assessment of VVA signs on physical examination, vaginal health index including assessment of pH, overall elasticity, epithelial mucosa, fluid secretion type, and consistency and moisture will be used as an objective method of evaluation of therapy.
3. Assessment of sexual satisfaction of both male and female partners:

Sexual satisfaction was measured using the Arabic version of the Index of Sexual Satisfaction (ISS) and female sexual function index (FSFI) questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia)

  * Patients with vaginal health index \< 15.
  * All patients have already finished cancer therapy or are on anti-estrogen treatment.
  * Married sexually active
  * Patients who are not receiving any VVA treatment for at least 30 days before starting therapy.

Exclusion Criteria:

* Active or recent history of vulvovaginal inflammation or infection

  * History of vulvar or vaginal cancer.
  * Suspicious lesion in the vulvovaginal area on the gynecological examination

Primary outcomes:
measure: Vulvovaginal atrophy vaginal dryness severity scores
timeFrame: before treatment
measure: Vulvovaginal atrophy vaginal dryness severity scores
timeFrame: after 1 month
measure: Vulvovaginal atrophy vaginal dryness severity scores
timeFrame: after 2 months
measure: Vulvovaginal atrophy vaginal dryness severity scores
timeFrame: 3 months follow up
measure: Vulvovaginal atrophy dyspareunia severity scores
timeFrame: before treatment
measure: Vulvovaginal atrophy dyspareunia severity scores
timeFrame: after 1 month
measure: Vulvovaginal atrophy dyspareunia severity scores
timeFrame: after 2 months
measure: Vulvovaginal atrophy dyspareunia severity scores
timeFrame: 3 months follow up
measure: Vaginal health index total score
timeFrame: before treatment
measure: Vaginal health index total score
timeFrame: after 1 month
measure: Vaginal health index total score
timeFrame: after 2 months
measure: Vaginal health index total score
timeFrame: 3 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: Salma Omar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hersant B, SidAhmed-Mezi M, Belkacemi Y, Darmon F, Bastuji-Garin S, Werkoff G, Bosc R, Niddam J, Hermeziu O, La Padula S, Meningaud JP. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study. Menopause. 2018 Oct;25(10):1124-1130. doi: 10.1097/GME.0000000000001122.