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Chemotherapy-induced Nausea and VomitingNCT02970643

Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

A study testing Olanzapine and Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, run by Hee Jun Kim.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting. 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?
Olanzapine and Palonosetron
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
Jul 2016to Dec 2017
Phase
Interventional
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

  • European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • no severe cognitive compromise
  • Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
  • Confirmed histology

Who cannot join

  • European Cooperative Oncology Group (ECOG) performance status of 3 and 4
  • Nausea or vomiting in the 24 hours before enrollment
  • History of Nausea or vomiting Grade 3 before previous chemotherapy
  • Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
  • Bowel obstruction
  • Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more
Show all 13Show fewer
  • Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range
  • Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment
  • Treatment with another antiemetic agent before 48 hours before enrollment
  • Uncontrolled severe infection or uncontrolled severe comorbidity
  • Concurrent abdominal radiotherapy
  • Known hypersensitivity to olanzapine, palonosetron
  • Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month

About this study

Official title: Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting

The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.

Read the detailed description

This study was designed to evaluate efficacy and safety of olanzapine compared with 5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced nausea and vomiting.

Being tested
Olanzapine, Palonosetron
Keywords
Olanzapine, Chemotherapy-Induced Nausea and Vomiting, Moderate risk
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlanzapineDrug

    Also called Zyprexa

    Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO

  • PalonosetronDrug

    Also called Aloxi

    Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV

Study groups in NCT02970643
Study groupRoleWhat they receive
Olanzapine groupExperimentalPalonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group
Receives: Drug: Olanzapine; Drug: Palonosetron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea

    Measured: the overall assessment period (0 to 72 hours)

Secondary outcomes (1)

  1. Quality of life was evaluated according to MDASI-K

    Measured: the overall assessment period (0 to 72 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionSep 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02970643
Sponsor's protocol ID
C2016034
Status last verified
Nov 2016
First submitted
16 Nov 2016
Last updated
23 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.

    PubMed 27410922

  • Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.

    PubMed 19775450

  • Naeim A, Dy SM, Lorenz KA, Sanati H, Walling A, Asch SM. Evidence-based recommendations for cancer nausea and vomiting. J Clin Oncol. 2008 Aug 10;26(23):3903-10. doi: 10.1200/JCO.2007.15.9533.

    PubMed 18688059

  • Lohr L. Chemotherapy-induced nausea and vomiting. Cancer J. 2008 Mar-Apr;14(2):85-93. doi: 10.1097/PPO.0b013e31816a0f07.

    PubMed 18391612

  • American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22.

    PubMed 16717289

  • Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.

    PubMed 22024310

  • Vardy J, Chiew KS, Galica J, Pond GR, Tannock IF. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer. 2006 Apr 10;94(7):1011-5. doi: 10.1038/sj.bjc.6603048.

    PubMed 16552437

  • Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.

    PubMed 11013380

Questions about this trial

What is this clinical trial studying?

A study testing Olanzapine and Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, run by Hee Jun Kim.

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 4 inclusion and 13 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea (time frame: the overall assessment period (0 to 72 hours)). 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 NCT02970643, which also lists 8 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 23 Nov 2016.

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