Clinical trial NCT04929353: SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
Official title: (ImmunotheRapy SyMptom CApture) A RANDOMIZED CONTROLLED TRIAL OF SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma
Lung Cancer
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility 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)

Primary outcomes:
measure: 1. Decrease rate of irAEs ≥ grade 3 according to CTCAEs (Common Terminology Criteria for Adverse Events) with systematic symptom assessment
timeFrame: 36 months
Secondary outcomes:
measure: 1. Duration of irAEs ≥ grade 3
timeFrame: 36 months
measure: 2. Emergency hospital admission
timeFrame: 36 months
measure: 3. Admission to and duration of hospitalization
timeFrame: 36 months
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Oncologia Medica, Azienda Ospedaliera Universitaria
state: PG
Study officials:
References: