Patient Reported Outcomes Registry in Patient With Cancer Cachexia

NCT ID: NCT02983500

Last Updated: 2020-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-28

Study Completion Date

2019-07-24

Brief Summary

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Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.

Detailed Description

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The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia.

Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively.

These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.

Conditions

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Metastatic Pancreatic Cancer NSCLC, Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV
* Start of the first line palliative systemic treatment
* Ability to read and understand German
* Written informed consent

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharma Europe Ltd.

INDUSTRY

Sponsor Role collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manfred Welslau, MD

Role: PRINCIPAL_INVESTIGATOR

Medical practise for oncology

Locations

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Multiple sites all over Germany

Multiple Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IOM-0050346

Identifier Type: -

Identifier Source: org_study_id

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