Patient Reported Outcomes Registry in Patient With Cancer Cachexia (PROXie)

August 6, 2020 updated by: iOMEDICO AG

Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

253

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Multiple sites all over germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with locally advanced and unresectable or metastatic NSCLC (UICC Stage IIIB/IV) or locally advanced and unresectable or metastatic pancreatic cancer (UICC stage III/IV) at start of their first-line palliative systemic treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with loss of > 5 % body weight
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of underweight patients
Time Frame: 12 months
BMI < 20 kg/qm at start or during observation.
12 months
General health-related quality of life assessment
Time Frame: 12 months
At baseline, throughout and at the end of the study with SF 12 questionnaire.
12 months
Fatigue assessment
Time Frame: 12 months
At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).
12 months
Cachexia assessment
Time Frame: 12 months
At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Collaborators

Chugai Pharma Europe Ltd.

Investigators

  • Principal Investigator: Manfred Welslau, MD, medical practise for oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2016

Primary Completion (Actual)

July 24, 2019

Study Completion (Actual)

July 24, 2019

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-0050346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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