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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04812912

Enrollment

120

Registered

2021-03-24

Start date

2021-03-18

Completion date

2027-03-18

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms

Keywords

Early Onset Colorectal Cancer, Colorectal Cancer, 21-035, 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).

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

United States

Contacts

CONTACTAndrea Cercek, MD

cerceka@mskcc.org646-888-4189

CONTACTPaul Romesser, MD

romessep@mskcc.org646-888-2118

PRINCIPAL_INVESTIGATORAndrea Cercek, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026