Understanding sexual side effects after radiotherapy in female cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how radiotherapy and other cancer treatments affect sexual function in female patients with malignant neoplasms. Participants will provide consent for access to their medical records and complete quality of life and toxicity questionnaires before and after treatment, as well as every six months for two years. Additionally, blood samples will be collected to explore potential biomarkers related to sexual side effects. The goal is to improve understanding of these side effects and develop predictive models and interventions to enhance patient quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• M.D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Deborah C Marshall, MD MAS — Icahn School of Medicine at Mount Sinai
• Study coordinator: Deborah C Marshall, MD MAS
• Email: star.consortium@mssm.edu
• Phone: 201-500-5522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.