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AzTrials

Anatomic Stage 0 Breast Cancer AJCC v8Phase 1NCT04535323

Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer

A Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Therapeutic Autologous Platelet-rich Plasma in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is to find out possible benefits and/or side effects of platelet rich plasma for the treatment of genitourinary syndrome of menopause in patients with stage 0-III breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Quality-of-Life Assessment, Questionnaire Administration and Therapeutic Autologous Platelet-rich Plasma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
23 Sep 2020to 10 Jan 2024
Phase
Phase 1
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide written informed consent or have an appropriate representative available to do so
  • Ability to complete questionnaires by themselves or with assistance
  • Ability to comply with treatment plan and follow-up visits
  • Female patients >= 18 years
  • Histological confirmation of adenocarcinoma of the breast stage 0 - III with no evidence of recurrence. Additionally, patients with stage III require three or more years from initial diagnosis with no evidence of recurrence.
  • Natural, surgical, or medically induced menopause
  • Self-report of vaginal itching, irritation, burning, dryness, or dyspareunia
  • Triple negative or HER2 positive breast cancer =< 3 years from initial diagnosis

Who cannot join

  • Receiving any form of hormone replacement therapy, including topical estrogens, testosterone, and dehydroepiandrosterone (DHEA) or selective estrogen receptor modulator (SERM), including tamoxifen and ospemifene in the previous 3 months prior to enrollment
  • Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation
  • Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity
  • Pelvic organ prolapse greater than stage II
  • Pelvic surgery within 6 months
  • Known allergy to lidocaine or prilocaine
Show all 15Show fewer
  • Known allergy to silicone
  • Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy
  • Hemoglobin < 11.6 g/dL or > 15.5 g/dL. If the laboratory reports a single, non-clinically significant result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered non-exclusionary
  • Hematocrit < 34.9% or > 44.9%. If the laboratory reports a single, non-clinically significant result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered non-exclusionary
  • White blood cell count < 3.4 X 10^9/L or > 10.5 X 10^9/L. If the laboratory reports a single, non-clinically significant result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered non-exclusionary
  • Platelet count < 150 X 10^ 9/L or > 450 X 10^9/L. If the laboratory reports a single, non-clinically significant result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered non-exclusionary
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the treatment
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

Other trials in United States

About this study

Official title: A Phase I, Single Arm, Prospective Study to Evaluate the Treatment of Genitourinary Syndrome of Menopause With Platelet Rich Plasma (PRP) in Women With a History of Breast Cancer

This phase I trial is to find out possible benefits and/or side effects of platelet rich plasma for the treatment of genitourinary syndrome of menopause in patients with stage 0-III breast cancer. Platelet rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patients' arm. The blood is spun using a centrifuge that separates the plasma and red blood cells. This allows doctors to collect the platelet rich plasma that is then loaded into individual, sterile syringes for injection. Giving platelet rich plasma may help relief symptoms of genitourinary syndrome of menopause in patients with breast cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety and feasibility of use of platelet rich plasma (PRP) treatment in breast cancer survivors with genitourinary syndrome of menopause (GSM).

SECONDARY OBJECTIVE:

  1. To determine the preliminary efficacy in treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms, and patient global impression of improvement and tolerability.

OUTLINE:

Patients receive platelet rich plasma via injection into the vaginal area.

After completion of study treatment, patients are followed up for 6 months.

Being tested
Quality-of-Life Assessment, Questionnaire Administration, Therapeutic Autologous Platelet-rich Plasma
Medical subject headings
Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Therapeutic Autologous Platelet-rich PlasmaBiological

    Also called PRP, Therapeutic PRP

    Given via injection

Study groups in NCT04535323
Study groupRoleWhat they receive
Treatment of GSM (platelet rich plasma)ExperimentalPatients receive platelet rich plasma via injection into the vaginal area.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Therapeutic Autologous Platelet-rich Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Safety endpoint is defined as a lack of serious adverse events. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) will be used to grade the severity of adverse events that occur in this study.

    Measured: Up to 2 weeks post-treatment

  2. Tolerability of planned injection regimen with pain scores

    Feasibility will be based on whether or not 16 or more patients (> 80%) tolerate the planned injection regimen with pain scores during the procedure less than or equal to 4.

    Measured: Up to 6 months post-treatment

Secondary outcomes (8)

  1. Change in vaginal symptoms

    Assessed using the vaginal assessment scale. Will be summarized using descriptive statistics.

    Measured: Baseline up to 6 months

  2. Change in vulvar symptoms

    Assessed using the vulvar assessment scale. Will be summarized using descriptive statistics.

    Measured: Baseline up to 6 months

  3. Change in Day-to-Day Impact of Vaginal Aging score

    Will be summarized using descriptive statistics.

    Measured: Baseline up to 6 months

  4. Change in sexual function

    Will assess change in Female Sexual Function Index score. Will be summarized using descriptive statistics.

    Measured: Baseline up to 6 months

  5. Change in urinary symptoms

    Assessed with Urogenital Distress Index 6 score. Will be summarized using descriptive statistics.

    Measured: Baseline up to 6 months

  6. Objective vaginal changes - vaginal maturation index

    Assessed with vaginal maturation index

    Measured: Baseline up to 6 months

  7. Objective vaginal changes - vaginal health index score

    Assessed with vaginal health index score

    Measured: Baseline up to 6 months

  8. Objective vaginal changes - vaginal caliber

    Assessed with vaginal caliber

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start23 Sep 2020
  3. Primary completion10 Jan 2024
  4. Study completion10 Jan 2024

Resources

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 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04535323
Sponsor's protocol ID
20-002712
Other IDs
NCI-2021-02777
Status last verified
Apr 2024
First submitted
26 Aug 2020
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chen AH, Trabuco EC, Chumsri S, Thielen JM, Cornella JL, Shapiro SA, Heckman MG, Dukes RE, Arthurs JR, Blumenfeld SG, Yi J. Platelet-Rich Plasma for Genitourinary Syndrome of Menopause in Breast Cancer Survivors. Obstet Gynecol. 2025 Nov 1;146(5):728-736. doi: 10.1097/AOG.0000000000006081. Epub 2025 Sep 19.

    PubMed 40966714

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Therapeutic Autologous Platelet-rich Plasma in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic 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 8 inclusion and 15 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 3 Apr 2024. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Incidence of adverse events (time frame: Up to 2 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535323, which also lists 1 linked publication.

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 3 Apr 2024.

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