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

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hormone biomarker analysis

Diagnostic Test

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.

QoL Questionnaires

Behavioral

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.

Primary outcomes

Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y)

Time frame: 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

Time frame: Up to 30 months

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Cercek, MD

CONTACT

[email protected]

646-888-4189

Paul Romesser, MD

CONTACT

[email protected]

646-888-2118

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Mar 24, 2021
Registry last updated: Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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