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Completed

NCT Number: NCT02983500

Patient Reported Outcomes Registry in Patient With Cancer Cachexia

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

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Key information

Conditions

Metastatic Pancreatic Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Lung Diseases Lung Neoplasms NSCLC, Metastatic Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple sites all over Germany

Multiple Locations, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of patients with loss of > 5 % body weight

    Time frame: 18 months

Secondary outcomes

  1. Number of underweight patients

    Time frame: 12 months

    BMI < 20 kg/qm at start or during observation.

  2. 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.

  3. Fatigue assessment

    Time frame: 12 months

    At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).

  4. Cachexia assessment

    Time frame: 12 months

    At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Chugai Pharma Europe Ltd.

Registry information

Official study title

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

Acronym: PROXie

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2016
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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