Chemotherapy-Induced Nausea and VomitingPhase 2NCT01736917
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors
A Phase 2 study testing Fosaprepitant, Dexamethasone and 5HT3 in people with Chemotherapy-Induced Nausea and Vomiting, run by Lawrence Einhorn at 4 sites in United States.
Trial summary
The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting, compared to the results of our prior… Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- Fosaprepitant, Dexamethasone and 5HT3
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male patients ≥15 years of age with histologically or cytologically confirmed diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve.
- Written informed consent and HIPAA authorization for release of personal health information.
- Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for 72 hours prior to starting protocol therapy. Treatment must not start in registered patients until this criteria is met.
Who cannot join
- No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 1 year.
- No previous treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No concurrent participation in a clinical trial which involves another investigational agent.
- No use of agents expected to induce the metabolism of fosaprepitant which include: rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates.
- No concurrent use of agents which may inhibit metabolism of fosaprepitant which include: cisapride, macrolide antibiotics (erythromycin, clarithromycin, azithromycin), azole antifungal agents (ketoconazole, itraconazole, voriconazole, fluconazole), amifostine, nelfinavir, calcium channel antagonists such as verapamil and diltiazem, and ritonavir.
Show all 9Show fewer
- No concurrent use of warfarin while on study.
- No known history of anticipatory nausea or vomiting.
- No clinically significant infections as judged by the treating investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Nebraska Cancer Specialists
Omaha, Nebraska, 68114
Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: Phase II Study of Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-based Chemotherapy: Hoosier Oncology Group Study QL12-153
The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting, compared to the results of our prior study of aprepitant. This study will be the first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin. This will be a single arm, phase II study. The investigators propose to utilize intravenous (IV) fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is anticipated that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for 2-5 days after therapy. This study will test the value of fosaprepitant in this patient population.
Read the detailed description
OUTLINE: This is a multi-center study.
Treatment Regimen:
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
Any germ cell chemotherapy regimen utilizing cisplatin (20mg/m^2 x 5 days). This will usually be combined with bleomycin (BEP), etoposide (EP), ifosfamide (VIP), vinblastine (VeIP), paclitaxel (TIP) or epirubicin. All of these regimens get the identical cisplatin, which is the only highly emetic drug in any of the chemo regimens.
Acute emesis prophylaxis (administered per institutional standards prior to chemotherapy):
- Any 5HT3 receptor antagonist may be used days 1 through 5 or days 1, 3 and 5 if palonosetron is used per institutional standards.
- Dexamethasone 20mg PO (orally) daily, days 1 and 2
- Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
- Fosaprepitant 150mg IV on day 5
- Dexamethasone 4mg PO BID (twice a day) on days 6, 7 and 8
PRN (as needed) antiemetics allowed at the discretion of the treating investigator
- No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
ECOG Performance Status of 0-2
Life Expectancy: Not specified
Hematopoietic:
- White blood cell count (WBC) > 3.0 K/mm3
- Absolute neutrophil count ≥ 1.5 K/mm3
- Hemoglobin (Hgb) > 10 g/dL
- Platelets > 100 K/mm3
Hepatic:
- Bilirubin < 1.5 x ULN (upper limit of normal)
- Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN
Renal:
- Creatinine ≤ 2 mg/dl
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Being tested
- Fosaprepitant, Dexamethasone, 5HT3
- Keywords
- Fosaprepitant, 5HT3 Receptor Antagonists, Dexamethasone, Germ Cell Tumors, Testis Cancer, Rescue Medications
- Medical subject headings
- Vomiting, Neoplasms, Germ Cell and Embryonal, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosaprepitantDrug
Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophylaxis
DexamethasoneDrug
Dexamethasone 20mg PO daily on D1 and 2 for acute prophylaxis Dexamethasone 4mg PO BID on Days 6 through 8
5HT3Drug
Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used.
| Study group | Role | What they receive |
|---|---|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | Experimental | Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
* Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
* Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
* Dexamethasone 20mg PO (orally) daily, D1 and 2
* Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
* Fosaprepitant 150mg IV on D5
* Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
* No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Receives: Drug: Fosaprepitant; Drug: Dexamethasone; Drug: 5HT3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications
Measured: Days 1-8 of chemotherapy regimen
Secondary outcomes (3)
Total Number of Emetic Episodes
total number of emetic episodes
Measured: Days 1-8 of chemotherapy regimen
Use of Rescue Medications.
Total number of patients who received rescue medications.
Measured: Days 1-8 of chemotherapy regimen
Self-Reported Assessment of Nausea
the patient's self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.
The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day.
Measured: Days 1-8 of chemotherapy regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence Einhorn
- Sponsor type
- University, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Lawrence Einhorn, Hoosier Cancer Research Network
- Investigators
- Lawrence Einhorn, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736917
- Sponsor's protocol ID
- QL12-153
- Status last verified
- Apr 2016
- First submitted
- 21 Nov 2012
- Last updated
- 25 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Costantine Albany, Nasser H. Hanna, Joel Picus, Ralph J. Hauke, Christopher A. Fausel, Ziyue Liu, Mary J. Brames, Lawrence H. Einhorn. Phase II study of fosaprepitant plus 5HT3 receptor antagonists plus dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: Hoosier Oncology Group QL12-153. J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4594)
Brames MJ, Case-Eads S, Hanna NH, Fausel CA, Breen T, Einhorn LH. Phase II study of fosaprepitant +5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: A Hoosier Cancer Research Network Study. J Clin Oncol 33:5s, 2015 (suppl; abstr e20737)
Adra N, Albany C, Brames MJ, Case-Eads S, Johnson CS, Liu Z, Fausel CA, Breen T, Hanna NH, Hauke RJ, Picus J, Einhorn LH. Phase II study of fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study. Support Care Cancer. 2016 Jul;24(7):2837-42. doi: 10.1007/s00520-016-3100-y. Epub 2016 Feb 2.
PubMed 26838019
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-based Chemotherapy: Hoosier Oncology Group Study QL12-153
- ClinicalTrials.gov ID
- NCT01736917
- Acronym / sponsor ID
- QL12-153
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Keywords
- Fosaprepitant, 5HT3 Receptor Antagonists, Dexamethasone, Germ Cell Tumors, Testis Cancer, Rescue Medications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Lawrence EinhornUniversity, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Merck Sharp & Dohme LLC
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 25 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting, compared to the results of our prior study of aprepitant. This study will be the first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin. This will be a single arm, phase II study. The investigators propose to utilize intravenous (IV) fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is anticipated that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for 2-5 days after therapy. This study will test the value of fosaprepitant in this patient population.
Detailed description
OUTLINE: This is a multi-center study.
Treatment Regimen:
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
Any germ cell chemotherapy regimen utilizing cisplatin (20mg/m^2 x 5 days). This will usually be combined with bleomycin (BEP), etoposide (EP), ifosfamide (VIP), vinblastine (VeIP), paclitaxel (TIP) or epirubicin. All of these regimens get the identical cisplatin, which is the only highly emetic drug in any of the chemo regimens.
Acute emesis prophylaxis (administered per institutional standards prior to chemotherapy):
- Any 5HT3 receptor antagonist may be used days 1 through 5 or days 1, 3 and 5 if palonosetron is used per institutional standards.
- Dexamethasone 20mg PO (orally) daily, days 1 and 2
- Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
- Fosaprepitant 150mg IV on day 5
- Dexamethasone 4mg PO BID (twice a day) on days 6, 7 and 8
PRN (as needed) antiemetics allowed at the discretion of the treating investigator
- No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
ECOG Performance Status of 0-2
Life Expectancy: Not specified
Hematopoietic:
- White blood cell count (WBC) > 3.0 K/mm3
- Absolute neutrophil count ≥ 1.5 K/mm3
- Hemoglobin (Hgb) > 10 g/dL
- Platelets > 100 K/mm3
Hepatic:
- Bilirubin < 1.5 x ULN (upper limit of normal)
- Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN
Renal:
- Creatinine ≤ 2 mg/dl
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | Experimental | Drug: Fosaprepitant, Drug: Dexamethasone, Drug: 5HT3Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied. * Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days). Acute emesis prophylaxis: * Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards. * Dexamethasone 20mg PO (orally) daily, D1 and 2 * Fosaprepitant 150mg IV on day 3 Delayed emesis prophylaxis: * Fosaprepitant 150mg IV on D5 * Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator * No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients ≥15 years of age with histologically or cytologically confirmed diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve.
- Written informed consent and HIPAA authorization for release of personal health information.
- Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for 72 hours prior to starting protocol therapy. Treatment must not start in registered patients until this criteria is met.
Key exclusion criteria (9 listed)
- No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 1 year.
- No previous treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No concurrent participation in a clinical trial which involves another investigational agent.
- No use of agents expected to induce the metabolism of fosaprepitant which include: rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates.
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 |
|---|---|---|
| FosaprepitantFosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophylaxis | Drug | Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone |
| DexamethasoneDexamethasone 20mg PO daily on D1 and 2 for acute prophylaxis Dexamethasone 4mg PO BID on Days 6 through 8 | Drug | Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone |
| 5HT3Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used. | Drug | Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone |
Primary outcome
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
Time frame: Days 1-8 of chemotherapy regimen
complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications
3 secondary outcomes
Total Number of Emetic Episodes
Time frame: Days 1-8 of chemotherapy regimen
Use of Rescue Medications.
Time frame: Days 1-8 of chemotherapy regimen
Self-Reported Assessment of Nausea
Time frame: Days 1-8 of chemotherapy regimen
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundCostantine Albany, Nasser H. Hanna, Joel Picus, Ralph J. Hauke, Christopher A. Fausel, Ziyue Liu, Mary J. Brames, Lawrence H. Einhorn. Phase II study of fosaprepitant plus 5HT3 receptor antagonists plus dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: Hoosier Oncology Group QL12-153. J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4594)
- Results publicationBrames MJ, Case-Eads S, Hanna NH, Fausel CA, Breen T, Einhorn LH. Phase II study of fosaprepitant +5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: A Hoosier Cancer Research Network Study. J Clin Oncol 33:5s, 2015 (suppl; abstr e20737)
- Derived from this study: PubMed 26838019Adra N, Albany C, Brames MJ, Case-Eads S, Johnson CS, Liu Z, Fausel CA, Breen T, Hanna NH, Hauke RJ, Picus J, Einhorn LH. Phase II study of fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study. Support Care Cancer. 2016 Jul;24(7):2837-42. doi: 10.1007/s00520-016-3100-y. Epub 2016 Feb 2.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- 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.
Lawrence Einhorn, M.D. study chair
Hoosier Cancer Research Network
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosaprepitant, Dexamethasone and 5HT3 in people with Chemotherapy-Induced Nausea and Vomiting, run by Lawrence Einhorn at 4 sites in United States.
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 3 inclusion and 9 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 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (time frame: Days 1-8 of chemotherapy regimen). 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 NCT01736917, which also lists 3 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 25 May 2016.