Ovarian Function of Nasopharyngeal Carcinoma Women Survivors

January 4, 2022 updated by: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Nasopharyngeal Carcinoma

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

602

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Haiqiang Mai, MD, PhD
Phone Number: 86-20-8734-3643
Email: maihq@sysucc.org.cn

Study Contact Backup

Name: Qiuyan Chen, MD, PhD
Phone Number: 86-20-8734-3380
Email: chenqy@sysucc.org.cn

Study Locations

China
- Guangdong
  - Guangzhou, Guangdong, China, 510060
    - Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
    - Contact:
      
      Haiqiang Mai, MD,PhD
      
      Phone Number: 862087343380 86-20-8734-3643
      
      Email: maihq@mail.sysu.edu.cn
    - Contact:
      
      Qiuyan Chen, MD, PhD
      
      Phone Number: 862087343380 86-20-8734-3380
      
      Email: chenqy@sysucc.org.cn
    - Principal Investigator:
      
      Haiqiang Mai
    - Principal Investigator:
      
      Qiuyan Chen
    - Sub-Investigator:
      
      Shanshan Guo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female NPC patients (18 to 45 years old)

Description

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis
Age between 18-45, female
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
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) .
Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
No history of infertility.
No history of hysterectomy or bilateral ovariectomy.
Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
Patients with severe, uncontrolled disease or infections.
Refuse or fail to sign the informed consent .
Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature Ovarian Failure (POF) Time Frame: 3 years after Radiotherapy	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress-Free Survival (PFS) Time Frame: 3 years after Radiotherapy	Progress-free survival is calculated from the date of registration to the date of the first progress at any site.	3 years after Radiotherapy
Pregnancy and birth outcome Time Frame: Within 6 month of diagnosis, or 3-5years after Radiotherapy	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
Overall Survival (OS) Time Frame: 3 years after Radiotherapy	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
Locoregional Relapse-Free Survival (LRFS) Time Frame: 3 years after Radiotherapy	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
Distant Metastasis-Free Survival (DMFS) Time Frame: 3 years after Radiotherapy	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 10, 2022

Primary Completion (Anticipated)

January 10, 2025

Study Completion (Anticipated)

January 10, 2026

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)