Chemotherapy-induced Nausea and VomitingPhase 3LUNG-NEPANCT04201769
Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin
A Phase 3 study testing Netupitant/Palonosetron and Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Consorzio Oncotech at 26 sites in Italy.
Trial summary
This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Netupitant/Palonosetron and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 26 sitesItaly
- Study dates
- 25 Nov 2016to Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old.
- Histologically or cytologically confirmed diagnosis of NSCLC
- Patients naїve to cisplatin-containing chemotherapy as well as any prior chemotherapy containing either highly or moderately emetogenic agents given for NSCLC or other malignancy.
- Patients scheduled to receive their first cycle of cisplatin-based chemotherapy at a dose ≥70 mg/m2 either alone or in combination with other agents of low or minimal potential of emetogenicity (i.e., pemetrexed, gemcitabine±bevacizumab, vinorelbine) as neo-adjuvant, adjuvant or palliative therapy. Patients with progressive disease on therapy with an EGFR-TKI (Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) and scheduled to receive cisplatin-based chemotherapy will be eligible for the study.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1.
- Body Mass Index ≥18.5.
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- Written informed consent before study entry.
- If women of childbearing potential age: effective contraceptive measures must be used during all the planned course of chemotherapy and up to 30 days after last NEPA administration.
- Normal hepatic function (≤2 times the upper limit of normal for liver transaminases) and renal function (creatinine ≤ 1.5 times the upper limit of normal).
- Ability and willingness of the patient to complete the diary and study questionnaires.
Who cannot join
- Symptomatic brain metastases.
- Patients scheduled to receive radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 following the first cycle of chemotherapy.
- Patients scheduled to receive concurrent chemo/radiotherapy for NSCLC.
- Treatment with investigational medications within 30 days before the study medication.
- Myocardial infarction within the last 6 months.
- Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK-1RA (Neurokinin-1 Receptor Antagonist) and excipients (see section 6.1 of Akynzeo SPC).
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- Uncontrolled diabetes mellitus or active infection.
- Nausea and vomiting in the 24 hours before study treatment.
- Chronic use of systemic corticosteroids (except for topical and inhaled corticosteroids) or any other agent with anti-emetic potential. Patients receiving dexamethasone on the day before chemotherapy for prevention of the pemetrexed-induced skin rash will be eligible for the study.
- Patient's inability to take oral medication.
- Gastrointestinal obstruction or active peptic ulcer.
- Pregnancy or breast feeding.
- Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for at least 5 years (see also inclusion criteria if prior chemotherapy treatment).
- Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Italy26 sites
A.O.U. Consorziale Policlinico di Bari
Bari
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari
ASST Spedali Civili di Brescia
Brescia
Azienda Ospedaliera Cosenza
Cosenza
Azienda ULSS 1 Dolomiti - Ospedale Santa Maria del Prato
Feltre, BL
ASST Lecco - P.O. "A. Manzoni"
Lecco
ASST Ovest Milanese - Ospedale di Legnano
Legnano, MI
A.O.U. Policlinico di Modena
Modena
Ospedale San Gerardo - ASST Monza
Monza
A.O.R.N. dei Colli - Ospedale Monaldi
Naples
AOU San Luigi Gonzaga
Orbassano, TO
Casa di Cura di Alta Specialità Dip. Oncologico di III livello "La Maddalena"
Palermo
Ospedale S. Maria della Misericordia
Perugia
Ospedale di Piacenza
Piacenza
IRCCS Arcispedale S. Maria Nuova
Reggio Emilia
A.O. San Camillo Forlanini
Roma
A.O. San Giovanni - Addolorata
Roma
Fondazione Policlinico "A. Gemelli" - Università Cattolica Sacro Cuore
Roma
Istituto Nazionale Tumori "Regina Elena"
Roma
Policlinico Tor Vergata
Roma
Ospedale Civile SS. Annunziata
Sassari
Ospedale Umberto I - RAO SR
Syracuse
P.O. "San Giuseppe Moscati"
Taranto
ASST Bergamo Ovest - Ospedale di Teviglio
Treviglio, BG
Azienda ULSS 2 Marca Trevigiana - Ospedale di Treviso
Treviso
A.O.U.I. Verona - Policlinico "G.B. Rossi"
Verona
About this study
Official title: A Standard Regimen of Dexamethasone in Comparison to Two Dex-sparing Regimens in Addition to NEPA in Preventing CINV in naïve NSCLC Patients to be Treated With Cisplatin Based Chemotherapy: a Three-arm, Open-label, Randomized Study
This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy
Read the detailed description
On day 1 (day of chemotherapy), all eligible patients will receive oral NEPA (300 mg netupitant/0.5 mg palonosetron), 60 minutes before chemotherapy, and intravenous dexamethasone 12 mg, 30 minutes before chemotherapy initiation.
For the prevention of delayed CINV, patients will be assigned randomly to one of the following treatment arms:
- Test arm A: no further anti-emetic prophylaxis on days 2 thorough 4;
- Test arm B: oral dexamethasone 4 mg once per day in the morning of days 2 and 3;
- Reference arm C: oral dexamethasone 4 mg twice per day on days 2 thorough 4.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Netupitant/Palonosetron, Dexamethasone
- Keywords
- nausea, vomiting, lung cancer, DEX-Sparing
- Medical subject headings
- Vomiting, Nausea, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netupitant/PalonosetronDrug
Also called Netupitant/Palonosetron 300-0.5 milligrams Oral Capsule [AKYNZEO]
NEPA is adiministered 60 minutes before chemotherapy, on day 1
DexamethasoneDrug
Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1.
The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Oral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy.
No further anti-emetic prophylaxis on days 2 thorough 4. Receives: Drug: Netupitant/Palonosetron; Drug: Dexamethasone |
| Arm B | Experimental | Oral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy.
Oral dexamethasone 4 mg once per day in the morning of days 2 and 3. Receives: Drug: Netupitant/Palonosetron; Drug: Dexamethasone |
| Arm C | Active comparator | Oral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy.
Oral dexamethasone 4 mg twice per day on days 2 thorough 4. Receives: Drug: Netupitant/Palonosetron; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR)
The proportion of patients achieving a complete response, defined as no emetic episode and no use of rescue medication, during the overall study period (day 1 thorough 5) of the first cycle of chemotherapy.
Measured: During the overall phase (day 1 thorough 5) of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Secondary outcomes (11)
CR (acute and delayed).
No emetic episode and no use of rescue medication, during the acute and delayed phases
Measured: During the acute (within 24 hours post-chemotherapy) and delayed (days 2 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Complete control
No emetic episode, no rescue medication, and no more than mild nausea. Severity of nausea will be self-reported by the patient using a verbal scale (none, mild, moderate, and severe).
Measured: During the acute (within 24 hours post-chemotherapy), delayed (days 2 thorough 5) and overall (days 1 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Proportion of patients with no emetic episode
No emetic episode
Measured: During the acute (within 24 hours post-chemotherapy), delayed (days 2 thorough 5) and overall (days 1 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Proportion of patients with no nausea
No nausea. Severity of nausea will be self-reported by the patient using a verbal scale (none, mild, moderate, and severe).
Measured: During the acute (within 24 hours post-chemotherapy), delayed (days 2 thorough 5) and overall (days 1 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Impact of nausea and vomiting on patient's quality of life
Impact of nausea and vomiting on patient's quality of life as recorded by the Italian version of the FLIE (Functional Living Index-Emesis) questionnaire, according to subjective assessment by each patient on day 6.
The questionnaire consists of 18 questions: the first set of 9 questions refers to nausea and the second set of 9 questions refers to vomiting.
Each question uses a visual analogue scale. Scale ranges are 1-7 (in some questions 1 indicates no effect on patient's quality of life, in other questions 1 indicates a great deal of an effect on patient's quality of life).
Measured: On day 6 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Patient global satisfaction with anti-emetic therapy,
Patient global satisfaction with antiemetic therapy, as measured by a Visual Analogue Scale (VAS) on day 6. Scale ranges are 0-10 (0 represents maximum dissatisfaction, 10 represents maximum satisfaction)
Measured: On day 6 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Safety profile
Safety profile according to NCI-CTCAE version 5.0
Measured: During all the safety study period (up to three weeks after the start of cisplatin-based chemotherapy)
Cross-sectional baseline evaluation of weight loss (WL)
Weight loss will be assessed through the BMI (Body Mass Index) adjusted weight loss grading system (WLGS).
WL as classified according to WLGS, a grading system using the combination of %WL and BMI categories. The analysis will be laid out in a 5x5 matrix representing five different %WL categories within each of the five different BMI categories (25 possible combinations of WL and BMI).
Percentage of WL will be defined as follows: [(current weight in Kg - previous weight in Kg)/previous weight in Kg] x 100. Previous patient weight (i.e., the usual weight) within the last 6 months (or "usual weight") will be also collected at baseline. BMI will be calculated as current weight/square of the body height (Kg/m2);
Measured: During the Screening phase (up to 7 days before the first cycle of chemotherapy administration - each cycle is 7 or 21 days)
Nutritional intake
Nutritional intake will be assessed with an ad hoc question adapted from the Patient Generated-Subjective Global Assessment (PG-SGA) questionnaire.
Measured: During the Screening phase (up to 7 days before the first cycle of chemotherapy administration - each cycle is 7 or 21 days)
Cancer-related symptom self-assessment
Cancer-related symptom self-assessment, as recorded by the Italian version of the ESAS (Edmonton Symptom Assessment Scale) questionnaire, according to subjective assessment by each patient on day 1 (before cisplatin-based chemotherapy initiation), will be performed.
The ESAS is a validated symptom inventory tool assessing the current intensity of 10 common symptoms in cancer patients, each with an 11-point numerical rating scale from 0 (no symptom) to 10 (worst intensity).
Measured: On day 1 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Cancer-related symptom self-assessment association with WLGS and nutritional intake
The association between Cancer-related symptom self-assessment and WLGS and nutritional intake will be examined using linear regression models.
Measured: On day 1 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start25 Nov 2016
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, multicenter, randomized, open-label, parallel-group, active-comparator, three-arm, non-inferiority study
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorzio Oncotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilio Bria, MD, Study chair, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, UCSC - Rome (Italy)Luigi Celio, MD, Study director, Fondazione IRCCS "Istituto Nazionale Tumori" - Milan (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201769
- Sponsor's protocol ID
- LUNG-NEPA
- Acronym
- LUNG-NEPA
- Status last verified
- Apr 2020
- First submitted
- 11 Dec 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Celio L, Aapro M. Characteristics of nausea and its impact on health-related quality of life in cisplatin-treated patients receiving dexamethasone-sparing prophylaxis: an analysis of the LUNG-NEPA study. Support Care Cancer. 2024 Mar 4;32(3):204. doi: 10.1007/s00520-024-08406-5.
PubMed 38433125Celio L, Bartsch R, Aapro M. Dexamethasone-sparing regimens with NEPA (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting in older patients (>65 years) fit for cisplatin: A sub-analysis from a phase 3 study. J Geriatr Oncol. 2023 Jul;14(6):101537. doi: 10.1016/j.jgo.2023.101537. Epub 2023 Jun 7.
PubMed 37290207Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study). Sci Rep. 2023 Jan 23;13(1):1257. doi: 10.1038/s41598-023-28464-9.
PubMed 36690734Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer. 2022 Aug 24;22(1):915. doi: 10.1186/s12885-022-10018-3.
PubMed 35999527
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standard Regimen of Dexamethasone in Comparison to Two Dex-sparing Regimens in Addition to NEPA in Preventing CINV in naïve NSCLC Patients to be Treated With Cisplatin Based Chemotherapy: a Three-arm, Open-label, Randomized Study
- ClinicalTrials.gov ID
- NCT04201769
- Acronym / sponsor ID
- LUNG-NEPA / LUNG-NEPA
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- nausea, vomiting, lung cancer, DEX-Sparing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Consorzio OncotechUniversity, hospital or other
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy
Detailed description
On day 1 (day of chemotherapy), all eligible patients will receive oral NEPA (300 mg netupitant/0.5 mg palonosetron), 60 minutes before chemotherapy, and intravenous dexamethasone 12 mg, 30 minutes before chemotherapy initiation.
For the prevention of delayed CINV, patients will be assigned randomly to one of the following treatment arms:
- Test arm A: no further anti-emetic prophylaxis on days 2 thorough 4;
- Test arm B: oral dexamethasone 4 mg once per day in the morning of days 2 and 3;
- Reference arm C: oral dexamethasone 4 mg twice per day on days 2 thorough 4.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase III, multicenter, randomized, open-label, parallel-group, active-comparator, three-arm, non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Netupitant/Palonosetron, Drug: DexamethasoneOral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy. No further anti-emetic prophylaxis on days 2 thorough 4. |
| Arm B | Experimental | Drug: Netupitant/Palonosetron, Drug: DexamethasoneOral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy. Oral dexamethasone 4 mg once per day in the morning of days 2 and 3. |
| Arm C | Active comparator | Drug: Netupitant/Palonosetron, Drug: DexamethasoneOral Netupitant/Palonosetron (NEPA) and intravenous Dexamethasone (DEX) on Day 1 of chemotherapy. Oral dexamethasone 4 mg twice per day on days 2 thorough 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ≥ 18 years old.
- Histologically or cytologically confirmed diagnosis of NSCLC
- Patients naїve to cisplatin-containing chemotherapy as well as any prior chemotherapy containing either highly or moderately emetogenic agents given for NSCLC or other malignancy.
- Patients scheduled to receive their first cycle of cisplatin-based chemotherapy at a dose ≥70 mg/m2 either alone or in combination with other agents of low or minimal potential of emetogenicity (i.e., pemetrexed, gemcitabine±bevacizumab, vinorelbine) as neo-adjuvant, adjuvant or palliative therapy. Patients with progressive disease on therapy with an EGFR-TKI (Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) and scheduled to receive cisplatin-based chemotherapy will be eligible for the study.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1.
Key exclusion criteria (14 listed)
- Symptomatic brain metastases.
- Patients scheduled to receive radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 following the first cycle of chemotherapy.
- Patients scheduled to receive concurrent chemo/radiotherapy for NSCLC.
- Treatment with investigational medications within 30 days before the study medication.
- Myocardial infarction within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Netupitant/PalonosetronAlso: Netupitant/Palonosetron 300-0.5 milligrams Oral Capsule [AKYNZEO]NEPA is adiministered 60 minutes before chemotherapy, on day 1 | Drug | Arm A, Arm B, Arm C |
| DexamethasoneIntravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1. The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm | Drug | Arm A, Arm B, Arm C |
Primary outcome
Complete Response (CR)
Time frame: During the overall phase (day 1 thorough 5) of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
The proportion of patients achieving a complete response, defined as no emetic episode and no use of rescue medication, during the overall study period (day 1 thorough 5) of the first cycle of chemotherapy.
11 secondary outcomes
CR (acute and delayed).
Time frame: During the acute (within 24 hours post-chemotherapy) and delayed (days 2 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Complete control
Time frame: During the acute (within 24 hours post-chemotherapy), delayed (days 2 thorough 5) and overall (days 1 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Proportion of patients with no emetic episode
Time frame: During the acute (within 24 hours post-chemotherapy), delayed (days 2 thorough 5) and overall (days 1 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Proportion of patients with no nausea
Time frame: During the acute (within 24 hours post-chemotherapy), delayed (days 2 thorough 5) and overall (days 1 thorough 5) phases of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Impact of nausea and vomiting on patient's quality of life
Time frame: On day 6 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Patient global satisfaction with anti-emetic therapy,
Time frame: On day 6 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Safety profile
Time frame: During all the safety study period (up to three weeks after the start of cisplatin-based chemotherapy)
Cross-sectional baseline evaluation of weight loss (WL)
Time frame: During the Screening phase (up to 7 days before the first cycle of chemotherapy administration - each cycle is 7 or 21 days)
Nutritional intake
Time frame: During the Screening phase (up to 7 days before the first cycle of chemotherapy administration - each cycle is 7 or 21 days)
Cancer-related symptom self-assessment
Time frame: On day 1 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Cancer-related symptom self-assessment association with WLGS and nutritional intake
Time frame: On day 1 of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 38433125Celio L, Aapro M. Characteristics of nausea and its impact on health-related quality of life in cisplatin-treated patients receiving dexamethasone-sparing prophylaxis: an analysis of the LUNG-NEPA study. Support Care Cancer. 2024 Mar 4;32(3):204. doi: 10.1007/s00520-024-08406-5.
- Derived from this study: PubMed 37290207Celio L, Bartsch R, Aapro M. Dexamethasone-sparing regimens with NEPA (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting in older patients (>65 years) fit for cisplatin: A sub-analysis from a phase 3 study. J Geriatr Oncol. 2023 Jul;14(6):101537. doi: 10.1016/j.jgo.2023.101537. Epub 2023 Jun 7.
- Derived from this study: PubMed 36690734Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study). Sci Rep. 2023 Jan 23;13(1):1257. doi: 10.1038/s41598-023-28464-9.
- Derived from this study: PubMed 35999527Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer. 2022 Aug 24;22(1):915. doi: 10.1186/s12885-022-10018-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Bria, MD study chair
Fondazione Policlinico Universitario "A. Gemelli" IRCCS, UCSC - Rome (Italy)
Luigi Celio, MD study director
Fondazione IRCCS "Istituto Nazionale Tumori" - Milan (Italy)
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Netupitant/Palonosetron and Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Consorzio Oncotech at 26 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) (time frame: During the overall phase (day 1 thorough 5) of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04201769, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.