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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04812912
• Collaborator: (none)
• Enrollment: 120
• Locations: 7
• Anticipated Duration (Months): 36
• Patients Per Site: 17.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma	Diagnostic Test: Hormone biomarker analysis; Behavioral: QoL Questionnaires

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients
• Actual Study Start Date: Mar 18, 2021
• Anticipated Primary Completion Date: Mar 18, 2024
• Anticipated Study Completion Date: Mar 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Participants with Colon Cancer This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis	Diagnostic Test: Hormone 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.; Behavioral: QoL 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.
Participants with Rectal Cancer This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis	Diagnostic Test: Hormone 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.; Behavioral: QoL 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 Outcome Measures

1. Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y) [Up to 30 months]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center at Suffolk - Commack	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau	Rockville Centre	New York	United States	11553

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Andrea Cercek, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT04812912
• Other Study ID Numbers: 21-035
• First Posted: Mar 24, 2021
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: Early Onset Colorectal Cancer; Colorectal Cancer; 21-035; Memorial Sloan Kettering Cancer Center
• Additional relevant MeSH terms: Colorectal Neoplasms; Hormones

Study Results

No Results Posted as of May 26, 2022