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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04812912
• Other study ID #: 21-035
• Status: Recruiting
• Start date: March 18, 2021
• Est. completion date: March 18, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Andrea Cercek, MD
• Phone: 646-888-4189
• Email: cerceka[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 18, 2025
• Est. primary completion date: March 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Hormone biomarker analysis
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.

Behavioral:
• QoL Questionnaires
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

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center at Suffolk - Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Hartford Healthcare Cancer Alliance (Data collection only)	Hartford	Connecticut
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y)		Up to 30 months
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center