The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 7
- Primary Endpoint
- Change in testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH in young male patients (<50y) undergoing therapy for colorectal cancer
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy 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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported