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A Multi Center Study of Sexual Toxicities After Radiotherapy

ConditionMalignant Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with female sexual organs ages 18 and older.

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.

Disqualifiers

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;

Trial population

Adult female patients treated with pelvic radiation therapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients with female sexual organs treated with pelvic radiotherapy1 intervention

Trial outcomes

Primary outcomes

1

Establish Sexual Quality of Life Cohort

Establish a cohort of patients with female sexual organs receiving radiotherapy

Time frame
2 years

Secondary outcomes

1

Describe sexual quality of life

Describe sexual quality of life for patients with female sexual organs receiving radiotherapy

Time frame
2 years
2

Describe dosimetric predictors of sexual outcomes

Describe the dosimetric predictors of sexual outcomes for patients with female sexual organs receiving radiotherapy

Time frame
2 years
3

Describe imaging predictors of sexual outcomes

Describe the imaging predictors of sexual outcomes for patients with female sexual organs receiving radiotherapy

Time frame
2 years
4

Describe microbiome predictors of sexual outcomes

Describe the microbiome predictors of sexual outcomes for patients with female sexual organs receiving radiotherapy

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Emory University

Collaborator

M.D. Anderson Cancer Center

Collaborator

Source ClinicalTrials.gov
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