Chemotherapy-induced Nausea and VomitingPhase 3PRaCTiCENCT03219710
"Olanzapine for Prevention of Chemotherapy Induced Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC)"
A Phase 3 study testing Ondansetron, Dexamethasone and Aprepitant in people with Chemotherapy-induced Nausea and Vomiting, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Chemotherapy induced nausea and vomiting (CINV) is one of the most distressing toxicities of cancer treatment. It can occur up to 90% in case of highly emetogenic chemotherapy (HEC) use. It is important to effectively manage CINV for a number of reasons. Acute phase vomiting can lead to vomiting in the delayed phase. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Ondansetron, Dexamethasone and Aprepitant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2017to 31 Jul 2019
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age group 5-18 years with weight between ≥15 kg
- All subjects must have a confirmed diagnosis of malignancy
- European Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Scheduled to receive highly emetogenic chemotherapy as assessed using the Pediatric Oncology Group of Ontario Guideline for emetogenicity Classification
- Patients receiving first cycle of chemotherapy
- Children's caregiver who can understand Hindi or English and are willing to participate in the study (with written informed consent)
Who cannot join
- Have had treatment within 14 days prior to study enrollment with olanzapine or 30 days prior to study enrollment with another antipsychotic agent
- Planned to receive quinolone antibiotics while receiving olanzapine
- Have uncontrolled hypertension
- Receive other antipsychotic agents, amifostine, citalopram, CYP1A2 inducers or inhibitors
- Have a history of neuroleptic malignant syndrome, a seizure disorder, hypersensitivity to olanzapine.
- Children with known cardiac disease
Show all 11Show fewer
- Are pregnant or breast-feeding
- Had received or will receive RT to abdomen or pelvis in the week prior to treatment
- Vomited in the 24 hours prior to study
- Previous exposure to HEC
- Abnormal lab values (ANC<1500/mm3, TLC<3000/mm3, Plt<100,000/mm3, AST/ALT> 2.5 times of ULN, bill>1.5 times of ULN, S.cr>1.5 times of ULN, patient on systemic steroids
Trial locations and contacts
1 site in 1 country.
India1 site
Dr Bra Irch, Aiims, New Delhi
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: "Olanzapine for Prevention of Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC): An Investigator Initiated, Randomized, Open-label Trial" (PRaCTiCE Trial: PRevention of ChemoTherapy Induced Emesis in Children)
Chemotherapy induced nausea and vomiting (CINV) is one of the most distressing toxicities of cancer treatment. It can occur up to 90% in case of highly emetogenic chemotherapy (HEC) use. It is important to effectively manage CINV for a number of reasons. Acute phase vomiting can lead to vomiting in the delayed phase. It causes poor compliance with further therapy. Quality of life is compromised. It is easier to prevent nausea/vomiting than to treat it. Though strategies for prevention of CINV have been improved, it is still a significant problem. Newer drugs were explored and studied. The complete response rates were further increased with usage of olanzapine, an FDA approved antipsychotic, which blocks multiple neurotransmitters in the central nervous system.
Olanzapine has been studied in multiple randomized trials in adults for its safety and efficacy in prevention of CINV. Various RCTs have demonstrated the superiority of olanzapine for prevention of CINV in patients receiving highly and moderately emetogenic chemotherapy. Olanzapine has been approved for prevention of CINV in adults.
Unfortunately there are no large randomized trials demonstrating the efficacy of olanzapine for CINV prevention in children receiving HEC. The positive experience with olanzapine reported in adult oncology patients has prompted some pediatric clinicians to prescribe olanzapine for individual children receiving chemotherapy. Olanzapine is frequently used for the treatment of schizophrenia and bipolar disorder in children and adolescents. Though various studies have demonstrated safety of olanzapine in children, data regarding the efficacy of olanzapine in children and adolescents for prevention of CINV is limited. There are many small studies describing the safety and efficacy of olanzapine for prevention of CINV. However, there are no large randomized trials. Olanzapine is available in generic form and is not an expensive drug. Therefore we would like to conduct a randomized trial to look for the efficacy of olanzapine in pediatric population for prevention of CINV
Read the detailed description
Children and adolescents registered with confirmed diagnosis of cancer will be assessed for eligibility criteria and enrolled in the study. Subjects will be randomized into study and control groups using table of random numbers generated by computer. Sequentially numbered, opaque, sealed envelopes will be used for concealed allocation. After randomization, subjects will be interviewed 1 hour prior 1st dose of chemotherapy. Subjects will receive the antiemetic drugs for four days as per the allotted arm. All doses will be administered under supervision and 30 minutes before chemotherapy. The data will be collected from each patient from day 1 to day5 from the last dose of chemotherapy. The details will contain different items dealing with demographic and clinical characteristic of the subjects. A Diary will be maintained for nausea and vomiting episodes. It will help in collecting data regarding nausea, vomiting along with some additional variables like chemotherapy related toxicities, requirement of any rescue medication. The subjects will be given the diary for symptom assessment on day 1 and it will be filled up under the supervision of the investigator on day 1 till completion of chemotherapy. The diary will be given to the subjects following the completion of chemotherapy to record all the events (incidence and severity of nausea, vomiting, requirement of rescue medication and other toxicities ) and will be contacted by phone or in person by the investigator. Edmonton's symptom assessment criterion will be used in the diary for assessing severity of nausea. The NCI's CTCAEv4.03 criterion will be used to assess the severity of vomiting and adverse events based on the data provided by the patient in the diary. Patients/attendants will be explained about the filling of the diary and will maintain it for recording of vomiting. A modified intention-to-treat population will be used for efficacy analysis. Proportion of patients with CR during acute phase, delayed phase and overall period will be compared between the two arms.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Ondansetron, Dexamethasone, Aprepitant, Olanzapine
- Keywords
- Chemotherapy induced nausea and vomiting, olanzapine
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Ondansetron will be given at a dosage of 0.15mg/kg IV/PO q8h.
DexamethasoneDrug
Dexamethasone will be given as 3mg/m2 IV/PO q8h.
AprepitantDrug
Aprepitant will be given as per the weight. weight (15-40kg) - Day1 to Day 3 - 80 mg PO weight (>40 kg) - Day 1 -125mg , Day 2 \& Day 3 - 80 mg PO
OlanzapineDrug
olanzapine will be given as 0.14mg/kg PO (rounded off to nearest 2.5 mg )
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Patient on control group (ODA) with weight category of 15-40 kg will receive:
D1-D3 Dexamethasone 3 mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg;
The patient on control group with weight category of > 40 kg will receive:
D1- Dexamethasone 3 mg/m2 , ondansetron(0.15 mg/kg ), Aprepitant 125 mg; D2-D3 Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg
Note: Aprepitant will be administered as single oral dose, dexamethasone and ondansetron will be administered q 8h (PO/IV) Receives: Drug: Ondansetron; Drug: Dexamethasone; Drug: Aprepitant |
| Arm B | Experimental | weight category of 15-40 kg will receive: D1-D3 Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg and olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) D4-olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg)
Weight category of > 40 kg in study group will receive:
D1- Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg, ), Aprepitant 125 mg; olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) D2-D3 Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg; olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) D4-olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) Note: Aprepitant \& Olanzapine will be administered as single oral dose, dexamethasone and ondansetron will be administered q 8h (PO/IV) Receives: Drug: Ondansetron; Drug: Dexamethasone; Drug: Aprepitant; Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with no episodes of vomiting as assessed by CTCAE v4.03 till 120 hours after highly emetogenic chemotherapy.
The number of patients achieving complete response as defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
Measured: 120 hours after administration of chemotherapy.
The number of patients with no episodes of vomiting as assessed by CTCAE v.03 till 24 hours after highly emetogenic chemotherapy.
The number of patients achieving complete response: defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
Measured: Till 24 hours after administration of chemotherapy.
The number of patients with no episodes of vomiting as assessed by CTCAE v4.03after 24 hours till 120 hours post highly emetogenic chemotherapy.
The number of patients achieving complete response as defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
Measured: From 24 hours till 120 hours post administration of chemotherapy.
Secondary outcomes (3)
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" till 24 hours after highly emetogenic chemotherapy.
The no.of patients with no nausea, assessed by "Edmonton symptom assessment scale" during the study period will be compared between the groups
Measured: Till 24 hours after administration of chemotherapy.
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" after 24 hours till 120 hours post highly emetogenic chemotherapy.
The no.of patients with no nausea, assessed by "Edmonton symptom assessment scale" during the study period will be compared between the groups
Measured: After 24 hours till 120 hours post administration of chemotherapy.
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" till 120 hours post highly emetogenic chemotherapy.
The no.of patients with no nausea, assessed by "Edmonton symptom assessment scale" during the study period will be compared between the groups
Measured: Till 120 hours after administration of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Jul 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMAVATH DEVENDRA NAIK, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219710
- Sponsor's protocol ID
- IECPG-151/26.04.2017
- Acronym
- PRaCTiCE
- Status last verified
- Aug 2019
- First submitted
- 10 May 2017
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naik RD, V S, Singh V, Pillai AS, Dhawan D, Bakhshi S. Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial. J Clin Oncol. 2020 Nov 10;38(32):3785-3793. doi: 10.1200/JCO.20.00871. Epub 2020 Sep 15.
PubMed 32931400
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Olanzapine for Prevention of Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC): An Investigator Initiated, Randomized, Open-label Trial" (PRaCTiCE Trial: PRevention of ChemoTherapy Induced Emesis in Children)
- ClinicalTrials.gov ID
- NCT03219710
- Acronym / sponsor ID
- PRaCTiCE / IECPG-151/26.04.2017
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Chemotherapy induced nausea and vomiting, olanzapine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 17 Jul 2017 (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.
Chemotherapy induced nausea and vomiting (CINV) is one of the most distressing toxicities of cancer treatment. It can occur up to 90% in case of highly emetogenic chemotherapy (HEC) use. It is important to effectively manage CINV for a number of reasons. Acute phase vomiting can lead to vomiting in the delayed phase. It causes poor compliance with further therapy. Quality of life is compromised. It is easier to prevent nausea/vomiting than to treat it. Though strategies for prevention of CINV have been improved, it is still a significant problem. Newer drugs were explored and studied. The complete response rates were further increased with usage of olanzapine, an FDA approved antipsychotic, which blocks multiple neurotransmitters in the central nervous system.
Olanzapine has been studied in multiple randomized trials in adults for its safety and efficacy in prevention of CINV. Various RCTs have demonstrated the superiority of olanzapine for prevention of CINV in patients receiving highly and moderately emetogenic chemotherapy. Olanzapine has been approved for prevention of CINV in adults.
Unfortunately there are no large randomized trials demonstrating the efficacy of olanzapine for CINV prevention in children receiving HEC. The positive experience with olanzapine reported in adult oncology patients has prompted some pediatric clinicians to prescribe olanzapine for individual children receiving chemotherapy. Olanzapine is frequently used for the treatment of schizophrenia and bipolar disorder in children and adolescents. Though various studies have demonstrated safety of olanzapine in children, data regarding the efficacy of olanzapine in children and adolescents for prevention of CINV is limited. There are many small studies describing the safety and efficacy of olanzapine for prevention of CINV. However, there are no large randomized trials. Olanzapine is available in generic form and is not an expensive drug. Therefore we would like to conduct a randomized trial to look for the efficacy of olanzapine in pediatric population for prevention of CINV
Detailed description
Children and adolescents registered with confirmed diagnosis of cancer will be assessed for eligibility criteria and enrolled in the study. Subjects will be randomized into study and control groups using table of random numbers generated by computer. Sequentially numbered, opaque, sealed envelopes will be used for concealed allocation. After randomization, subjects will be interviewed 1 hour prior 1st dose of chemotherapy. Subjects will receive the antiemetic drugs for four days as per the allotted arm. All doses will be administered under supervision and 30 minutes before chemotherapy. The data will be collected from each patient from day 1 to day5 from the last dose of chemotherapy. The details will contain different items dealing with demographic and clinical characteristic of the subjects. A Diary will be maintained for nausea and vomiting episodes. It will help in collecting data regarding nausea, vomiting along with some additional variables like chemotherapy related toxicities, requirement of any rescue medication. The subjects will be given the diary for symptom assessment on day 1 and it will be filled up under the supervision of the investigator on day 1 till completion of chemotherapy. The diary will be given to the subjects following the completion of chemotherapy to record all the events (incidence and severity of nausea, vomiting, requirement of rescue medication and other toxicities ) and will be contacted by phone or in person by the investigator. Edmonton's symptom assessment criterion will be used in the diary for assessing severity of nausea. The NCI's CTCAEv4.03 criterion will be used to assess the severity of vomiting and adverse events based on the data provided by the patient in the diary. Patients/attendants will be explained about the filling of the diary and will maintain it for recording of vomiting. A modified intention-to-treat population will be used for efficacy analysis. Proportion of patients with CR during acute phase, delayed phase and overall period will be compared between the two arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Ondansetron, Drug: Dexamethasone, Drug: AprepitantPatient on control group (ODA) with weight category of 15-40 kg will receive: D1-D3 Dexamethasone 3 mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg; The patient on control group with weight category of > 40 kg will receive: D1- Dexamethasone 3 mg/m2 , ondansetron(0.15 mg/kg ), Aprepitant 125 mg; D2-D3 Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg Note: Aprepitant will be administered as single oral dose, dexamethasone and ondansetron will be administered q 8h (PO/IV) |
| Arm B | Experimental | Drug: Ondansetron, Drug: Dexamethasone, Drug: Aprepitant, Drug: Olanzapineweight category of 15-40 kg will receive: D1-D3 Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg and olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) D4-olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) Weight category of > 40 kg in study group will receive: D1- Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg, ), Aprepitant 125 mg; olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) D2-D3 Dexamethasone 3mg/m2, ondansetron (0.15 mg/kg,), Aprepitant 80 mg; olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) D4-olanzapine 0.14mg/kg (rounded off to nearest 2.5 mg) Note: Aprepitant \& Olanzapine will be administered as single oral dose, dexamethasone and ondansetron will be administered q 8h (PO/IV) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age group 5-18 years with weight between ≥15 kg
- All subjects must have a confirmed diagnosis of malignancy
- European Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Scheduled to receive highly emetogenic chemotherapy as assessed using the Pediatric Oncology Group of Ontario Guideline for emetogenicity Classification
- Patients receiving first cycle of chemotherapy
Key exclusion criteria (11 listed)
- Have had treatment within 14 days prior to study enrollment with olanzapine or 30 days prior to study enrollment with another antipsychotic agent
- Planned to receive quinolone antibiotics while receiving olanzapine
- Have uncontrolled hypertension
- Receive other antipsychotic agents, amifostine, citalopram, CYP1A2 inducers or inhibitors
- Have a history of neuroleptic malignant syndrome, a seizure disorder, hypersensitivity to olanzapine.
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 |
|---|---|---|
| OndansetronOndansetron will be given at a dosage of 0.15mg/kg IV/PO q8h. | Drug | Arm A, Arm B |
| DexamethasoneDexamethasone will be given as 3mg/m2 IV/PO q8h. | Drug | Arm A, Arm B |
| AprepitantAprepitant will be given as per the weight. weight (15-40kg) - Day1 to Day 3 - 80 mg PO weight (>40 kg) - Day 1 -125mg , Day 2 \& Day 3 - 80 mg PO | Drug | Arm A, Arm B |
| Olanzapineolanzapine will be given as 0.14mg/kg PO (rounded off to nearest 2.5 mg ) | Drug | Arm B |
Primary outcome
The number of patients with no episodes of vomiting as assessed by CTCAE v4.03 till 120 hours after highly emetogenic chemotherapy.
Time frame: 120 hours after administration of chemotherapy.
The number of patients achieving complete response as defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
The number of patients with no episodes of vomiting as assessed by CTCAE v.03 till 24 hours after highly emetogenic chemotherapy.
Time frame: Till 24 hours after administration of chemotherapy.
The number of patients achieving complete response: defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
The number of patients with no episodes of vomiting as assessed by CTCAE v4.03after 24 hours till 120 hours post highly emetogenic chemotherapy.
Time frame: From 24 hours till 120 hours post administration of chemotherapy.
The number of patients achieving complete response as defined as, no episode of vomiting , assessed by CTCAE v.4.03 will be compared between the groups.
3 secondary outcomes
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" till 24 hours after highly emetogenic chemotherapy.
Time frame: Till 24 hours after administration of chemotherapy.
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" after 24 hours till 120 hours post highly emetogenic chemotherapy.
Time frame: After 24 hours till 120 hours post administration of chemotherapy.
The number of patients with no episodes of nausea as assessed by "Edmonton symptom assessment scale" till 120 hours post highly emetogenic chemotherapy.
Time frame: Till 120 hours after administration of chemotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 32931400Naik RD, V S, Singh V, Pillai AS, Dhawan D, Bakhshi S. Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial. J Clin Oncol. 2020 Nov 10;38(32):3785-3793. doi: 10.1200/JCO.20.00871. Epub 2020 Sep 15.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Nausea and Vomiting
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron, Dexamethasone and Aprepitant in people with Chemotherapy-induced Nausea and Vomiting, run by All India Institute of Medical Sciences at 1 site in India.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients with no episodes of vomiting as assessed by CTCAE v4.03 till 120 hours after highly emetogenic chemotherapy. (time frame: 120 hours after administration of chemotherapy.). The study lists 3 primary outcomes in all. 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 NCT03219710, which also lists 1 linked publication.
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 20 Aug 2019.