Management of Cancer Therapy Related Vulvovaginal Atrophy

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

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.

Study Overview

• Status: Completed
• Conditions: Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: Platelet rich plasma; Device: non cross-linked hyaluronic acid; Device: topical HA gel

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 25211
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRP- treated Group A; 15 female patients will receive 2 vaginal PRP injections one month apart.	Device: Platelet rich plasma; PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing.
Active Comparator: PRP-HA treated Group B; 15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart.	Device: Platelet rich plasma; PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing.; Device: non cross-linked hyaluronic acid; HA filling is a known modality for rejuvenation
Active Comparator: Control Group C; 15 female patients will receive topical non-cross-linked hyaluronic acid gel applied every three days for 2 months as a control group	Device: topical HA gel; the standard treatment of vaginal atrophy and dryness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vulvovaginal atrophy vaginal dryness severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	before treatment
Vulvovaginal atrophy vaginal dryness severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	after 1 month
Vulvovaginal atrophy vaginal dryness severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	after 2 months
Vulvovaginal atrophy vaginal dryness severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	3 months follow up
Vulvovaginal atrophy dyspareunia severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	before treatment
Vulvovaginal atrophy dyspareunia severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	after 1 month
Vulvovaginal atrophy dyspareunia severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	after 2 months
Vulvovaginal atrophy dyspareunia severity scores	scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms	3 months follow up
Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	before treatment
Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	after 1 month
Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	after 2 months
Vaginal health index total score	scores range from 5-25 with lower scores signifying greater atrophy	3 months follow up

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Salma Omar, MD, Alexandria University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 0201349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No