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
Study Sites (2)
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