SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS

NCT04929353 | Unknown

• 1 other identifier: IRMA
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 1. Decrease rate of irAEs ≥ grade 3 according to CTCAEs (Common Terminology Criteria for Adverse Events) with systematic symptom assessment

  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.

  36 months

Secondary Outcomes (3)

• 1. Duration of irAEs ≥ grade 3

  36 months

• 2. Emergency hospital admission

  36 months

• 3. Admission to and duration of hospitalization

  36 months

Study Arms (2)

ARM A

OTHER

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

Arm B

OTHER

Standard symptom reporting following the conventional modalities of clinical oncology practice

Other: Systematic symptom assessment

Interventions

Systematic symptom assessment OTHER

* Systematic symptom assessment * Conventional symptom assessment

ARM A; Arm B

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Oncologia Medica, Azienda Ospedaliera Universitaria

Perugia, PG, 06132, Italy

Location

MeSH Terms

Conditions

Melanoma; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology at the University of Perugia

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 18, 2021
• Study Start: June 20, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2024
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)