Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05394428

Conditions

Malignant Neoplasms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief summary:

The purpose of this research is to understand how radiotherapy and other cancer treatments impact sexual function in female cancer patients and to try to answer a question about why some patients who receive radiotherapy are more likely to have side effects than others. The results of this study may improve our understanding of why sexual side effects occur and in turn develop predictive models and biomarkers of sexual side effects and other side effects that may impact sexual function. The results of this study may also lead to improvements in the techniques used to deliver radiotherapy or the development of interventions that will prevent or reduce sexual side effects and improve quality of life for female patients with cancer.

Conditions

Malignant Neoplasms

Study ID

NCT05394428

Start date

Oct 4, 2022

Status verified date

Jun, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with female sexual organs ages 18 and older.
  • Patients must meet at least one of the following two criteria:

  • have been sexually active in the 36 months prior to initiating cancer treatment.
  • have the intent to be sexually active in the 24 months following treatment..
  • Patients must be able to provide consent and be willing to participate.
  • Patients must have primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer planned to receive pelvic radiotherapy.\*\* Patients must have an Eastern Cooperative Oncology Group performance status <=2.

Exclusion Criteria:

  • planned for or undergone extensive pelvic surgery (e.g. pelvic exenteration, non-TME techniques, or surgeries otherwise affecting pudendal neurovasculature);
  • have clinically or radiologically detectable widespread metastasis;
  • have limited life expectancy due to comorbid disease;
  • have a personal history of cancer other than non-melanoma skin cancer in the last 5 years;
  • have contraindications or strong relative contraindications to radiotherapy at baseline as determined by the treating radiation oncologist (pregnancy, lactation, genetic susceptibility to cancer from ionizing radiotherapy, connective tissue disorders, inflammatory/irritable bowel disease, history of prior pelvic radiotherapy).
  • have persistent, infectious gastroenteritis, colitis or gastritis;
  • have persistent or chronic diarrhea of unknown etiology; have recurrent or untreated GI infection (clostridium difficile or H. pylori);
  • have current or recurrent vaginal infection;
  • have current or recent antibiotic use (within 2 months).

Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the STAR Study.

Patients may be enrolled on the STAR Study concurrently with another study or clinical trial.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with female sexual organs treated with pelvic radiotherapy

Patients with female sexual organs treated with pelvic radiotherapy.

Interventions

No intervention

No intervention

Primary outcome measure

  • Establish Sexual Quality of Life Cohort [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Deborah C Marshall, MD MAS

201-500-5522star.consortium@mssm.edu

Julia Brody-Barre

201-500-55222julia.brody-barre@mountsinai.org

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Mylin Torres, MD, BA

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Julia Brody-Barre

201-500-55225julia.brody-barre@mountsinai.org

Principal Investigator:

Deborah C Marshall, MD

M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Anuja Jhingran, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-22.