Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Corpus Uteri Carcinoma Clinical Trial

— SEXUTOX  

Official title:

Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650987
• Other study ID #: SEXUTOX
• Status: Completed
• Phase: N/A
• First received: July 20, 2012
• Last updated: August 5, 2016
• Start date: May 2009
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Description:

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria:

• Patients whose treatment is provided to Centre Oscar Lambret

• With a corpus uteri adenocarcinoma, no metastatic, treated by:

• Surgery and observation without complementary treatment

• Or surgery and adjuvant radiotherapy

• Or Surgery and curietherapy of vaginal dome

• With a cervix carcinoma, stade IA2 to IIB proximal, treated by :

• External radiochemotherapy and curietherapy

• Or only surgery

• Or pre-surgical curietherapy and surgery

• Age > 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Corpus Uteri Carcinoma
• Uterine Neoplasms

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities including on sexual function	According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary	up to 3 years	No
Secondary	Compare the various scales of toxicity	Compare the various scales of toxicity	up to 3 years	No
Secondary	Study the sexual behavior modifications	According to a questionnaire and a personal discussion	up to 3 years	No
Secondary	Specify correlation modifications of sexual behavior	Specify the existence of a correlation between toxicities included modifications and sexual behavior modifications	up to 3 years	No