Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

Arthralgia Clinical Trial

— BEVARTHRALGIA2  

Official title:

Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455907
• Other study ID #: 2017_50
• Secondary ID: 2017-A03012-51
• Status: Completed
• Start date: January 3, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Self-administered questionnaire survey to determine the presence or absence of joint pain during bevacizumab treatment for lung, ovarian, colorectal cancers.

The principal end-point is the frequency of arthralgia after 6 months of treatment with Bevacizumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with ovarian, colorectal or lung cancer receiving bevacizumab therapy

• Male or female (aged =18 years old)

• Performance Status (PS) between 0 and 2

• Expected life> 3 months

• Ability to answer a self-questionnaire

• Obtaining the non-opposition of patient participation

Exclusion Criteria:

• Pregnant or lactating woman

• Rapid evolution of neoplastic pathology

• Major cognitive disorders that do not allow filling of the self-questionnaire

• Impossibility to submit to medical monitoring for social, psychological or geographical reasons

• Patients under guardianship or curatorship

Related Conditions & MeSH terms

• Arthralgia

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Hôpital Huriez. CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of arthralgia	Frequency of joint manifestations of any grade according to the CTCAE (Common Terminology Criteria for Adverse Events) scale version 4.0 observed between the start of bevacizumab treatment and 6 months of treatment.	At 6 months
Secondary	correlation between global cancer response and occurrence of arthralgia		baseline, at 3 months, at 6 months
Secondary	auto questionnaire specific to the study	16 questions concerning the location, intensity, management of joint pain	Baseline at 3 months, at 6 months