Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

NCT03307044 | Completed DMC

• 2 other identifiers: OSU-17153NCI-2017-01554
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.

Conditions

Breast Carcinoma; Cancer Survivor; Cervical Carcinoma; Dyspareunia; Vaginal Dryness

Outcome Measures

Primary Outcomes (3)

• Change in Vaginal Assessment Scale score

  Using Vaginal Assessment Scale (VAS)

  Baseline up to 4 weeks

• Patient compliance rates

  Compliance rates with treatment will be assessed.

  Up to 4 weeks

• Feasibility of laser treatments defined by completion rates and tolerability of treatment

  Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics.

  Up to 4 weeks

Secondary Outcomes (2)

• Other symptoms of urogenital atrophy using the Urogenital Distress Inventory

  Up to 4 weeks

• Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare

  Up to 4 weeks

Study Arms (1)

Treatment (fractional CO2 laser therapy)

EXPERIMENTAL

Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.

Procedure: Laser Therapy; Other: Questionnaire Administration

Interventions

Laser Therapy PROCEDURE

Undergo fractional CO2 laser therapy

Also known as: Therapy, Laser

Treatment (fractional CO2 laser therapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (fractional CO2 laser therapy)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
• Symptoms of urogenital atrophy including dyspareunia or vaginal dryness

You may not qualify if:

• Patients with metastatic breast cancer
• Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
• Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
• Pelvic organ prolapse greater than stage II
• Prior reconstructive pelvic surgery involving mesh
• Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms; Dyspareunia

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Allison Quick, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: October 11, 2017
• Study Start: November 16, 2017
• Primary Completion: December 21, 2018
• Study Completion: May 5, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)