Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer
The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients
Memorial Sloan Kettering Cancer Center
120 participants
Mar 18, 2021
OBSERVATIONAL
Conditions
Summary
The purpose of this study is to find out how cancer treatments (chemotherapy and/or radiation therapy) affect reproductive and sexual health in people with early onset colorectal cancer. The study researchers will observe and track changes in hormone levels and in sexual and reproductive health in people with early onset colorectal cancer. This information will help researchers know more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility).
Eligibility
Inclusion Criteria6
- years of age and premenopausal (female) or 18-50 years of age (male) at time of diagnosis
- Histologic diagnosis of colorectal adenocarcinoma
- Able and willing to participate in the informed consent process
- Eligible for curative adjuvant or neoadjuvant therapy for colon or rectal cancer
- Willing and able to complete protocol questionnaires
- Rectal patients only: Individuals who will be receiving chemotherapy, followed by chemoradiotherapy (ChemoRT)
Exclusion Criteria4
- Prior systemic treatment for this malignancy
- Active or prior secondary malignancy
- History of ovarian resection (if female)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test.
Interventions
For female patients, hormone biomarker analysis will be performed to measure: anti-Mullerian hormone (AMH), estradiol and FSH in the blood. In male patients, hormone biomarkers of testicular function and spermatogenesis will be monitored: testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH. Sperm analysis will also be performed in male patients to monitor changes in sperm count.
All participants will respond to protocol questionnaires, which will include both validated questionnaires as well as non-validated ones. This design will allow for basic demographic, psychosocial and sexual-health-related data to be obtained.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT04812912