Impact of cancer treatments on reproductive and sexual health in young colorectal cancer patients
The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients
This study looks at how chemotherapy and radiation therapy affect the reproductive and sexual health of young people with early onset colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT04812912 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how chemotherapy and radiation therapy affect reproductive and sexual health in individuals diagnosed with early onset colorectal cancer. Researchers will monitor changes in hormone levels and assess sexual and reproductive health through questionnaires. The goal is to gather valuable information that can enhance understanding of the implications of cancer treatments on fertility and overall quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 years who are premenopausal females or 18-50 years for males, diagnosed with colorectal adenocarcinoma and eligible for curative therapy.
Not a fit: Patients with prior systemic treatment for colorectal cancer or those with active secondary malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that help improve reproductive health management for young colorectal cancer patients undergoing treatment.
How similar studies have performed: While there is ongoing research in the area of cancer treatment effects on reproductive health, this specific focus on early onset colorectal cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center at Suffolk - Commack — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Cercek, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Andrea Cercek, MD
- Email: cerceka@mskcc.org
- Phone: 646-888-4189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.