Treatment Algorithm for Nausea and Vomiting in the Palliative Phase

January 9, 2017 updated by: Radboud University Medical Center

Feasibility Study to Compare 2 Strategies of Treatment Algorithm for Treating Nausea and or Vomiting in the Palliative Phase of Cancer Care

Nausea and vomiting are frequently occurring problems in the palliative phase of patients with cancer. Between 20-50% of them regularly suffer from nausea, retching or vomiting. Often the cause of nausea and vomiting is multifactorial and symptomatic treatment is necessary.

Potential drugs for symptomatic anti-nausea therapy are metoclopramide, serotonin antagonists, the combination of both and dexamethasone as rescue medication in case of failure. There is no data that depicts which strategy is the best. This study will be conducted to unravel which treatment algorithm is most successful.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nausea and vomiting are frequently occurring problems in the palliative phase of patients with cancer. Between 20-50% of them regularly suffer from nausea, retching or vomiting. Often the cause of nausea and vomiting is multifactorial and symptomatic treatment is necessary.

Potential drugs for symptomatic anti-nausea therapy are metoclopramide, serotonin antagonists, the combination of both and dexamethasone as rescue medication in case of failure. There is no data that depicts which strategy is the best. This study will be conducted to unravel which treatment algorithm is most successful: 1 to start with metoclopramide, to add a serotonin antagonist (granisetron transdermal patch and 2 milligram granisetron oral loading dose if the patient can swallow) in case of failure and to add dexamethasone as rescue medication versus 2 an algorithm to start with a serotonin antagonist (granisetron transdermal patch and 2 milligram granisetron oral loading dose if the patient can swallow), to add metoclopramide in case of failure and to add dexamethasone as rescue medication. Granisetron plaster is a new formulation of a well known serotonin antagonist and might be useful especially within the patient group in the palliative phase.

The questions are:

Is it feasible to compare treatment algorithms for symptomatic treatment of nausea and vomiting in palliative cancer patients? And is a stepwise symptomatic treatment algorithm to manage nausea and vomiting using metoclopramide or granisetron transdermal patch as a start medication effective in palliative patients in at least one of both treatment arms? Patients will be asked to complete the QLQC30 and ESAS on different moments during the study. Besides, they will be asked to complete a diary for nausea severity (NRS scale 0-10) and for the frequency of vomiting and retching twice daily.

Success of a treatment algorithm is defined as nausea is < 3 on NRS or a decrease of >2 on NRS for nausea combined with an absence of vomiting or retching in the last 3 days. Incomplete success is defined as nausea of 3 on NRS during one occasion of the last 3 days before the end of study but less than 4, no more than one retching a day during that period and absence of vomiting. Complete failure is defined as nausea of 4 or more on an NRS during the last 3 days or more than one retching daily or any vomiting or in case the patient has stopped all medication due to side effects.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients 18 years or older in the palliative phase and
  • who suffer from nausea or vomiting with a rating on a numeric rating scale (NRS) of more than 2 and
  • have a wish to be treated and
  • where no treatable cause is assignable

Exclusion Criteria:

  • Patients not able to sign informed consent.
  • Patients with known contra-indications for metoclopramide, 5HT-3 antagonists or dexamethasone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: algorithm 1 first metoclopramide
metoclopramide 10 mg tablets 3x daily orally and in those patients that cannot swallow tablets the medication will be substituted by suppositories 10 mg 3x daily rectally. In case of failure, granisetron patch 3.1mg/24 hours will be added to the treatment and a loading dose of 2 mg granisetron oral if the patient can swallow. In case of toxicity metoclopramide will be stopped. In case of failure of the combination (second step) or toxicity, an oral dose of dexamethasone 8 mg will be added daily.
Drug: metoclopramide
metoclopramide 10 mg tablets 3x daily orally or suppositories 10 mg 3x daily rectally, use until toxicity
Drug: granisetron
granisetron patch 3.1mg/24 hours, use until toxicity
Other Names:
  • Sancuso
Drug: Dexamethasone
dexamethasone 8 mg, last step in both algorithms
Drug: Granisetron 2Mg Tablet
granisetron 2 mg loading dose
Active Comparator: algorithm 2 first granisetron

granisetron patch 3.1 mg/24 hours will be offered to the patient, and a loading dose of 2 mg granisetron oral if the patient can swallow In case of failure, metoclopramide 10 mg tablets 3x daily orally will be added and in those patients that cannot swallow tablets the oral medication will be substituted with rectal suppositories 10 mg. The granisetron patch will only be withdrawn from patients that suffer from clinically relevant toxicity. Metoclopramide will then be administered.

In the case of secondary failure or toxicity, dexamethasone 8 mg orally daily will be added.
Drug: metoclopramide
metoclopramide 10 mg tablets 3x daily orally or suppositories 10 mg 3x daily rectally, use until toxicity
Drug: granisetron
granisetron patch 3.1mg/24 hours, use until toxicity
Other Names:
  • Sancuso
Drug: Dexamethasone
dexamethasone 8 mg, last step in both algorithms
Drug: Granisetron 2Mg Tablet
granisetron 2 mg loading dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS nausea
Time Frame: 15 days
response defined as NRS <3 or decrease of more than 2 on NRS and absence of vomiting or retching in the last 3 days
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
days from T0 to control
Time Frame: two weeks
The time from T0 until the moment that nausea and vomiting/retching is in control
two weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility
Time Frame: 6 months
number of included patients a 6 months period
6 months
comparison of starting metoclopramide to starting with granisetron
Time Frame: 6 months
response defined as NRS <3 or decrease of more than 2 on NRS and absence of vomiting or retching in the last 3 days
6 months
quality of life
Time Frame: 15 days
QLQC30 scale
15 days
adverse events
Time Frame: 14/15 days
diary adverse events
14/15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: C.A.H.H.V.M. Verhagen, M.D. Ph.D., Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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