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

Recruiting

• Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma
• Interventions: Diagnostic Test: Hormone biomarker analysis; Behavioral: QoL Questionnaires

• Registration Number: NCT04812912
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-18
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-03-18
• Study Completion: 2026-03-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Colon Cancer	Hormone biomarker analysis	This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis
Participants with Colon Cancer	QoL Questionnaires	This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis
Participants with Rectal Cancer	Hormone biomarker analysis	This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis
Participants with Rectal Cancer	QoL Questionnaires	This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis

Primary Outcome Measures

Name	Time	Method
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
Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y)	Up to 30 months

Trial Locations

Locations (8)

Hartford Healthcare Cancer Alliance (Data collection only); 🇺🇸 Hartford, Connecticut, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, 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

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States