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Clinical Trials/NCT03455907
NCT03455907CompletedNot Applicable

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

University Hospital, Lille2 sites in 1 country71 target enrollmentStarted: January 3, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
71
Locations
2
Primary Endpoint
Frequency of arthralgia

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients

patients with ovarian, colorectal or bronchopulmonary cancer receiving Bevacizumab

Outcomes

Primary Outcomes

Frequency of arthralgia

Time Frame: At 6 months

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.

Secondary Outcomes

  • correlation between global cancer response and occurrence of arthralgia(baseline, at 3 months, at 6 months)
  • auto questionnaire specific to the study(Baseline at 3 months, at 6 months)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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