Clinical trial · Interventional
NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The lacking adherence to guidelines on prevention and treatment of different chemotherapy, targeted therapy, and immunotherapy induced toxicities is the reason why there are a potential incidence and duration increase of adverse events. It is clear the need of a collateral effect early recognition for an adequate clinical management and for limiting their intensity and duration. There is the need for a multicentre randomized clinical study in specific therapeutical settings (chemotherapy, target therapy, immunotherapy) assessing the impact of planned and ongoing patients' monitoring by nurses. The NICSO study foresees patient enrolment that is in adjuvant chemotherapy for breast cancer, colon, and lung; that is in chemotherapy or immunotherapy or with targeted therapy. Moreover, this working assesses toxicity differences (but also of QoL, number of PS access or non-planned medical examinations, number of hospitalization and number of recovery days) in patients that carried out a toxicity prevention and cure standard therapy in comparison with the standard assessment to which is added a periodic nursing phone intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive monitoring | Other | — | UNRESOLVED |
| Standard monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intensive monitoring
- description
- Intensive phone monitoring of drug adverse events
- interventionNames
- Other: Intensive monitoring
- type
- PLACEBO_COMPARATOR
- label
- Standard monitoring
- description
- Standard monitoring of drug adverse events
- interventionNames
- Other: Standard monitoring
Primary outcomes (1)
- measure
- Assessment of the number of days that have passed with at least a toxicity grade >= 3
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients aged \>18;
* Solid cancer histological diagnosis on treatment with one of the listed medicines, defined by treatment type:
* Adjuvant chemotherapy:
* anthracyclines and cyclophosphamide ± taxanes (breast cancer)
* oxaliplatin e fluoropyrimidine (colon cancer)
* combination of platin or its derivate (lung cancer)
* First line oral target therapy:
* sunitinib, pazopanib (renal cancer)
* gefitinib, erlotinib,afatinib, crizotinib (lung cancer)
* vemurafenib ± comimetinib, dabrafenib±trametinib (Melanoma)
* everolimus ± exemestane (breast cancer)
* vandetanib o lenvatinib (thyroid cancer)
* vismodegib (skin basal cell carcinoma)
* imatinib (GIST)
* Immunotherapy:
* drugs anti CTLA4
* drugs antiPD1/PDL-1
* their combination
* sign of informed consent form;
* phone call availability and accessibility;
* life expectancy higher than 6 months.
Exclusion Criteria:
* Presence of cerebral symptomatic metastasis;
* Presence of neurological or psychiatric disease or other conditions that stop the protocol procedure compliance;
* Previous systemic cancer treatment. These exclusion criteria are justified because usually a systemic cancer treatment cause changes in toxicity profile. This means that these patients have higher attention on their toxicities and probably receive codified preventive treatments already.
* Participation in other clinical studiesReferences
Publications (0)
Data not yet available