Pneumonitis After Radiotherapy for Lung Cancer

NCT04335409 | Completed

• 1 other identifier: PARALUC
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Major goals of radiotherapy include local disease control and improvement of the patients' prognoses. One possible side effect of radiotherapy for lung cancer is radiation pneumonitis. Severe (grade ≥3) radiation pneumonitis can even be fatal in approximately 2% of the patients. It would be important to identify patients developing radiation pneumonitis and requiring medical treatment early. In the present study, the patients are asked to complete a questionnaire (paper version) once a week during the period of radiotherapy and up to 24 weeks following radiotherapy. In this questionnaire, the patients are asked to state and rate their symptoms potentially associated with pneumonitis. Scoring points are assigned to the severity of the symptoms (symptom scores), and the resulting sum score (patient score) will be used for identification of radiation pneumonitis. The main goal of this trial is to evaluate the usefulness of a new symptom-based scoring system with respect to the identification of patients developing pneumonitis after radiotherapy of breast or lung cancer. The discriminative power of the symptom-based scoring system will be assessed by calculating the area under the ROC curve (AUC). Taking into account that 5% of patients will not qualify for Full Analysis Set, a total of 78 patients should be recruited. If statistical significance of the AUC is reached, the most-informative (optimal) scoring point to identify radiation pneumonitis will be derived. Sensitivity analyses will be conducted to further investigate the performance of the symptom-based scoring system. In 10 patients, the paper version of the symptom-based scoring system (questionnaire) will be supplemented by a mobile application (app) asking the same questions regarding symptoms potentially associated with radiation pneumonitis.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade ≥2 Radiation Pneumonitis

  Radiation pneumonitis will been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

  24 weeks following radiotherapy

Study Arms (1)

Participants irradiated for lung cancer

EXPERIMENTAL

Participants who receive radiotherapy for lung cancer and have risk factors for developing radiation pneumonitis. Risk factors include mean dose to the ipsilateral lung \>13 Gy plus at least one other factor (significant cardiovascular disease, history of heavy smoking (≥40 pack years), previous/concurrent chemotherapy or previous/adjuvant immunotherapy) or mean dose to the ipsilateral lung \>20 Gy without other factors.

Diagnostic Test: Questionnaire; Other: Mobile Application

Interventions

Questionnaire DIAGNOSTIC_TEST

The patients are asked to complete a questionnaire (paper version) once a week during the period of radiotherapy and up to 24 weeks following radiotherapy. In this questionnaire, the patients are asked to state and rate their symptoms potentially associated with pneumonitis. Scoring points are assigned to the severity of the symptoms (symptom scores), and the resulting sum score (patient score) will be used for identification of radiation pneumonitis.

Participants irradiated for lung cancer

Mobile Application OTHER

In 10 patients, the paper version of the symptom-based scoring system (questionnaire) will be supplemented by a mobile application (app) asking the same questions regarding symptoms potentially associated with pneumonitis.

Participants irradiated for lung cancer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven lung cancer
• Indication for radiotherapy
• Risk factors for developing radiation pneumonitis
• Age ≥18 years
• Written informed consent
• Capacity of the patient to contract

You may not qualify if:

• Pregnancy, Lactation
• Expected non-compliance

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Zealand University Hospital: collaborator

Study Sites (1)

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany

Lübeck, 23562, Germany

Location

Related Publications (1)

• Rades D, Werner EM, Glatzel E, Eggert MC, Olbrich D, Tvilsted S, Bohnet S. Pneumonitis after radiotherapy for lung cancer (PARALUC): an interventional study to create a symptom-based scoring system for identification of patients developing radiation pneumonitis. BMC Cancer. 2020 Aug 20;20(1):785. doi: 10.1186/s12885-020-07291-5.

  PMID: 32819311 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dirk Rades, MD

  Department of Radiation Oncology, University of Lübeck, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: September 1, 2020
• Primary Completion: June 20, 2022
• Study Completion: December 5, 2022
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)