Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

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

NCT ID: NCT04812912Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-07

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).

Arms & interventions

  • Diagnostic TestHormone 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.

  • BehavioralQoL 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.

Outcome measures

Primary

  • 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

Eligibility criteria

Sex: AllAge: 18 Years to 50 YearsHealthy volunteers: No
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 locations (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Recruiting
Andrea Cercek, MD · Contact

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

Recruiting
Andrea Cercek, MD · Contact

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

Recruiting
Andrea Cercek, MD · Contact

Memorial Sloan Kettering Cancer Center at Suffolk - Commack

Commack, New York, 11725

Recruiting
Andrea Cercek, MD · Contact

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

Recruiting
Andrea Cercek, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Andrea Cercek, MD · Contact

Memorial Sloan Kettering Nassau

Rockville Centre, New York, 11553

Recruiting
Andrea Cercek, MD · Contact