Ovarian Function of Nasopharyngeal Carcinoma Women Survivors

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Effects of Radiotherapy and Chemotherapy on Ovarian Function and Post-treatment Pregnancy Outcomes in Women With Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05183724
• Other study ID #: Ovarian Function of NPC
• Status: Not yet recruiting
• Start date: January 10, 2022
• Est. completion date: January 10, 2026

Study information

• Verified date: January 2022
• Source: Sun Yat-sen University
• Contact: Haiqiang Mai, MD, PhD
• Phone: 86-20-8734-3643
• Email: maihq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational cohort study aimed to explore the fertility concerns, fertility preservation strategies, fertility status (pregnancy and Ovarian Failure) and birth outcome among young woman Nasopharyngeal carcinoma patients.

Description:

The purpose of this study was to explore the effects of radiotherapy and chemotherapy on ovarian function and pregnancy outcome after treatment in female survivors of non-metastatic nasopharyngeal carcinoma, so as to clarify the relationship between ovarian dysfunction after treatment and pregnancy outcome, as well as clarify the relationship between pregnancy after treatment and tumour progression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 602
• Est. completion date: January 10, 2026
• Est. primary completion date: January 10, 2025
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis

2. Age between 18-45, female

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) =2.0 times the upper limit of normal (ULN) .

5. Adequate renal function: creatinine clearance rate=60 ml/min or Creatinine =1.5× upper limit of normal value.

6. No history of infertility.

7. No history of hysterectomy or bilateral ovariectomy.

8. Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

1. Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.

2. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.

3. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).

4. Patients with severe dysfunction of heart, liver, lung, kidney or marrow.

5. Patients with severe, uncontrolled disease or infections.

6. Refuse or fail to sign the informed consent .

7. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature Ovarian Failure (POF)	Premature Ovarian Failure (POF) was defined as menopause before age 40 years. Menopause was defined as cessation of menstruation at least 1 year before the date of the survey in the absence of pregnancy, breastfeeding, continuous use of progestagens or other medication causing amenorrhea, or surgical removal of uterus and/ or ovaries.	3 years after Radiotherapy
Secondary	Progress-Free Survival (PFS)	Progress-free survival is calculated from the date of registration to the date of the first progress at any site.	3 years after Radiotherapy
Secondary	Pregnancy and birth outcome	The pregnancy history and pregnancy outcome of female Nasopharyngeal carcinoma (NPC) patients before diagnosis of NPC would be investigate Within 6 months of diagnosis.; The pregnancy events and birth outcome of female NPC patients after diagnosis of NPC would be investigate among 3 to 5years after Radiotherapy.	Within 6 month of diagnosis, or 3-5years after Radiotherapy
Secondary	Overall Survival (OS)	The Overall Survival (OS) was defined as the duration from the date of registration assignment to the date of death from any cause or censored at the date of the last follow-up.	3 years after Radiotherapy
Secondary	Locoregional Relapse-Free Survival (LRFS)	The Locoregional Relapse-Free Survival (LRFS) is evaluated and calculated from the date of registration until the day of first locoregional relapse or until the date of the last follow-up visit	3 years after Radiotherapy
Secondary	Distant Metastasis-Free Survival (DMFS)	The DMFS is evaluated and calculated from the date of registration until the day of first distant metastases or until the date of the last follow-up visit.	3 years after Radiotherapy