We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS (IRMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04929353
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Roila Fausto, University Of Perugia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Immune-related adverse events (irAEs) can be different in their onset, kinetics and presentation but unlike chemotherapy are seldom predictable. Toxicity can affect nearly any organ system and multiple presentations of rare but severe irAEs have been reported, highlighting the relevance of vigilant monitoring.

Although early detection and timely management of high grade or special interest irAEs (such as cardiac and neurological) is obvious, it is unclear whether early identification of less serious events can lead to clinical benefit. Furthermore, it is of the utmost importance to develop new tools which can increase identification of side effects. The current study investigates systematic symptom assessment through an electronic patient reported outcome tool and aims to define whether this can reduce the rate of serious irAEs.


Condition or disease Intervention/treatment Phase
Melanoma Lung Cancer Other: Systematic symptom assessment Not Applicable

Detailed Description:
Systematic collection of symptom information during immunotherapy treatment will be compared to usual care in locally advanced or metastatic lung cancer (NSCLC or SCLC) and surgically resected or advanced melanoma. Electronic survey will be administered every other day to report 14 common symptoms selected from the NCI-PRO-CTCAE TM library developed by the NATIONAL CANCER INSTITUTE (NATIONAL INSTITUTES OF HEALTH, Bethesda, Maryland) Italian version (NCI-PRO-CTCAETM ITEMS-ITALIAN-Item Library Version 1.0).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: (ImmunotheRapy SyMptom CApture) A RANDOMIZED CONTROLLED TRIAL OF SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
Estimated Study Start Date : June 20, 2021
Estimated Primary Completion Date : June 20, 2023
Estimated Study Completion Date : June 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
ARM A
Self-Reporting by electronic survey consisting of 14 items selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0)
 Other: Systematic symptom assessment
  • Systematic symptom assessment
  • Conventional symptom assessment
Arm B
Standard symptom reporting following the conventional modalities of clinical oncology practice
 Other: Systematic symptom assessment
  • Systematic symptom assessment
  • Conventional symptom assessment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 1. Decrease rate of irAEs ≥ grade 3 according to CTCAEs (Common Terminology Criteria for Adverse Events) with systematic symptom assessment [ Time Frame: 36 months ]
    The electronic questionnaire surveys 14 symptoms selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0). The patient will rate their symptoms on a 5-point ordinal scale concerning the symptom frequency (never / rarely / sometimes / often / almost always), intensity (not at all / a little / quite / a lot / very much) and sometimes their interference with usual/daily activities (not at all / a little / quite / a lot / very much). The questionnaire must be collected from all patients (ARM A and ARM B) after randomization and before first treatment administration. Patients enrolled in ARM A must answer the questionnaire every other day. Alert will then be triggered when symptom level is not within the designated range. Following every activated alert, a physical examination and biochemical blood tests must be carried out.


Secondary Outcome Measures :
  1. 1. Duration of irAEs ≥ grade 3 [ Time Frame: 36 months ]
    Duration of irAEs ≥ grade 3

  2. 2. Emergency hospital admission [ Time Frame: 36 months ]
    Emergency hospital admission

  3. 3. Admission to and duration of hospitalization [ Time Frame: 36 months ]
    Admission to and duration of hospitalization


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old at time of signing Informed Consent Form
  • Histologically documented diagnosis of locally advanced or metastatic lung cancer (NSCLC or SCLC), surgically resected or advanced melanoma
  • Patients eligible for immunotherapy in any line of treatment, either alone or in combination with other immunotherapy drugs or with chemotherapy
  • Signed Informed Consent Form
  • Life expectancy ≥3 months
  • ECOG Performance Status of ≤2
  • Adequate hematologic and end-organ function, defined by laboratory test result by investigator's judgment

  • Viral hepatitis screening:

    1. Negative hepatitis B surface antigen (HBsAg) test
    2. For patients with positive total HBcAb test, hepatitis B virus (HBV) DNA test is required
    3. For patients with positive HCV antibody test, hepatitis C virus (HCV) RNA test is required

Exclusion Criteria:

  • Patients receiving immunotherapy at time of enrollment
  • > 1 grade adverse events from previous treatments
  • Any uncontrolled symptom
  • Clinically unstable brain metastases (i.e., symptomatic, not treated with RT and rapidly evolving)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04929353


Locations
Layout table for location information
Italy
Oncologia Medica, Azienda Ospedaliera Universitaria
Perugia, PG, Italy, 06132
Contact: ROILA FAUSTO    +39 075 585 8167    fausto.roila@unipg.it   
Contact: CURRA MARIA FRANCESCA    +39 075 578 4188    mfrancesca.curra@ospedale.perugia   
Sponsors and Collaborators
University Of Perugia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Roila Fausto, Professor of Medical Oncology at the University of Perugia, University Of Perugia
ClinicalTrials.gov Identifier: NCT04929353    
Other Study ID Numbers: IRMA
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas