Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer

Study Overview
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Brief Summary
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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).

Official Title
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The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients

Conditions
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Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma

Intervention / Treatment
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* Diagnostic Test: Hormone biomarker analysis
* Behavioral: QoL Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-40 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Colon Cancer<br>This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis | Diagnostic Test: Hormone biomarker analysis<br>* 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.<br>Behavioral: QoL Questionnaires<br>* 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.<br>|
| Participants with Rectal Cancer<br>This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis | Diagnostic Test: Hormone biomarker analysis<br>* 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.<br>Behavioral: QoL Questionnaires<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y) |  | Up to 30 months | 
| Change in testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH in young male patients (<50y) undergoing therapy for colorectal cancer |  | Up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Onset Colorectal Cancer, Colorectal Cancer, 21-035, Memorial Sloan Kettering Cancer Center