A Multi Center Study of Sexual Toxicities After Radiotherapy

NCT05394428 | Recruiting

• 1 other identifier: GCO 20-2369
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Establish Sexual Quality of Life Cohort

  Establish a cohort of patients with female sexual organs receiving radiotherapy

  2 years

Secondary Outcomes (4)

• Describe sexual quality of life

  2 years

• Describe dosimetric predictors of sexual outcomes

  2 years

• Describe imaging predictors of sexual outcomes

  2 years

• Describe microbiome predictors of sexual outcomes

  2 years

Study Arms (1)

Patients with female sexual organs treated with pelvic radiotherapy

Patients with female sexual organs treated with pelvic radiotherapy.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients with female sexual organs treated with pelvic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This is a study of female sexual organs, therefore patients of any gender identity with female sexual organs can participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients treated with pelvic radiation therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Emory University: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples; Microbiome Samples

MeSH Terms

Conditions

Neoplasms

Study Officials

• Deborah C Marshall, MD MAS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah C Marshall, MD MAS

CONTACT

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

Natasha Gironimi, MPH

CONTACT

646-984-9321; natasha.gironimi@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: October 4, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be submitted approximately 3 months after the data have been generated, following data cleaning and quality control, and released within 6 months.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose for institutional controlled access data. Unrestricted access anonymized data are available indefinitely at (Link to be included in the URL field below).

Locations

US (3)