What side effects are associated with this type of intervention?

Local estrogen therapy, used to treat symptoms like vaginal dryness in breast cancer patients, can be effective but its safety, particularly in estrogen-positive breast cancer patients, remains unclear. Common side effects include vaginal irritation and discharge. Replens, a non-hormonal moisturizer, is generally well-tolerated with minimal side effects, primarily limited to local irritation. Tamoxifen, another common treatment, can cause hot flashes, night sweats, and vaginal dryness, while aromatase inhibitors may lead to bone density loss, fractures, and cardiovascular risks. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including hormone therapies, chemotherapy, and targeted therapies. For managing symptoms like vaginal dryness in breast cancer patients, local estrogen therapy and non-hormonal moisturizers like Replens are being studied. While local estrogen therapy can help alleviate vaginal dryness, its use in breast cancer patients is carefully considered due to the hormone-sensitive nature of some breast cancers. Non-hormonal options like Replens provide an alternative for symptom relief without the risks associated with hormone therapy.

What other types of research exist?

Promising, novel alternatives to Vaginal Estrogen and Replens for breast cancer patients include vitamin D and E vaginal suppositories and polyacrylic acid.

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Estrogen

Estrogen vs Moisturizer for Vaginal Dryness in Breast Cancer Patients (REVIVE Trial)

Phase 2

Recruiting

Led By Polly Niravath, MD

Research Sponsored by Polly A. Niravath, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

18 years of age or older

Must not have

Current vaginal infection

Use of any exogenous estrogen within the preceding four weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4.5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial compares a hormone-releasing ring and a moisturizing cream for treating vaginal dryness in breast cancer patients. It focuses on post-menopausal women undergoing specific cancer treatments who suffer from vaginal dryness. The hormone ring works by adding estrogen locally, while the cream provides moisture without hormones.

Who is the study for?

This trial is for post-menopausal women aged 18 or older with stage I-III ER+ breast cancer, currently on adjuvant AI therapy, and suffering from vaginal dryness or related symptoms since starting the therapy. Participants must not use additional estrogen during the study and should have no current vaginal infections.

What is being tested?

The REVIVE study compares two treatments for vaginal dryness in breast cancer patients on anti-estrogen treatment: a vaginal estrogen product called ESTRING and a non-hormonal moisturizer known as Replens.

What are the potential side effects?

Potential side effects of ESTRING may include local irritation, discharge, or infection. Replens could cause similar local discomfort or reactions. Since these are topical treatments, systemic side effects are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am 18 years old or older.

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I have been diagnosed with early-stage, estrogen-receptor positive breast cancer.

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I am currently on hormone therapy for my cancer.

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I have had vaginal dryness, painful intercourse, or more than 3 UTIs a year since starting AI therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a current vaginal infection.

Select...

I have not used any estrogen products in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

What is the number of participants that show improvement of symptoms using vaginal estrogen as compared to the control.

Secondary study objectives

Compliance of use of Aromatase Inhibitor to assure safety

Other study objectives

EXPLORATORY OBJECTIVE

Evaluation of vaginal dryness by vaginal pH

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EstringExperimental Treatment1 Intervention

ESTRING

Group II: REPLENSActive Control1 Intervention

Replens

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endocrine therapies, such as tamoxifen and aromatase inhibitors, are pivotal in treating hormone receptor-positive breast cancer by blocking estrogen receptors or reducing estrogen production, thereby slowing tumor growth. Local estrogen therapy, like vaginal estrogen, specifically targets vaginal dryness caused by systemic anti-estrogen treatments without significantly raising systemic estrogen levels. Replens, a non-hormonal moisturizer, alleviates vaginal dryness by hydrating and maintaining vaginal tissue health. These treatments are essential for improving the quality of life for breast cancer patients by addressing side effects that impact daily living.

Exploring the Molecular Mechanism of the Drug-Treated Breast Cancer Based on Gene Expression Microarray.Implementing neoadjuvant endocrine strategies in ER-positive, HER2-negative breast cancer.Adjuvant therapy of breast cancer: update.