Patient Reported Outcomes Registry in Patient With Cancer Cachexia

Metastatic Pancreatic Cancer Clinical Trial

— PROXie  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983500
• Other study ID #: IOM-0050346
• Status: Completed
• Start date: August 28, 2016
• Est. completion date: July 24, 2019

Study information

• Verified date: August 2020
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Metastatic Pancreatic Cancer
• NSCLC, Metastatic
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Germany	Multiple sites all over Germany	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
iOMEDICO AG	Chugai Pharma Europe Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with loss of > 5 % body weight		18 months
Secondary	Number of underweight patients	BMI < 20 kg/qm at start or during observation.	12 months
Secondary	General health-related quality of life assessment	At baseline, throughout and at the end of the study with SF 12 questionnaire.	12 months
Secondary	Fatigue assessment	At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).	12 months
Secondary	Cachexia assessment	At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).	12 months