Treatment Algorithm for Nausea and Vomiting in the Palliative Phase

NCT03017391 | Unknown Phase 4

• 1 other identifier: CVS01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nausea; Vomiting; Cancer

Keywords

palliative care; palliative medicine; palliative

Outcome Measures

Primary Outcomes (1)

• NRS nausea

  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 Outcomes (1)

• days from T0 to control

  two weeks

Other Outcomes (4)

• feasibility

  6 months

• comparison of starting metoclopramide to starting with granisetron

  6 months

• quality of life

  15 days

Study Arms (2)

algorithm 1 first metoclopramide

ACTIVE COMPARATOR

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; Drug: granisetron; Drug: Dexamethasone; Drug: Granisetron 2Mg Tablet

algorithm 2 first granisetron

ACTIVE COMPARATOR

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 The granisetron patch will only be withdrawn from patients that suffer from clinically relevant toxicity.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; Drug: granisetron; Drug: Dexamethasone; Drug: Granisetron 2Mg Tablet

Interventions

metoclopramide DRUG

metoclopramide 10 mg tablets 3x daily orally or suppositories 10 mg 3x daily rectally, use until toxicity

algorithm 1 first metoclopramide; algorithm 2 first granisetron

granisetron DRUG

granisetron patch 3.1mg/24 hours, use until toxicity

Also known as: Sancuso

algorithm 1 first metoclopramide; algorithm 2 first granisetron

Dexamethasone DRUG

dexamethasone 8 mg, last step in both algorithms

algorithm 1 first metoclopramide; algorithm 2 first granisetron

Granisetron 2Mg Tablet DRUG

granisetron 2 mg loading dose

algorithm 1 first metoclopramide; algorithm 2 first granisetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Nausea; Vomiting; Neoplasms

Interventions

Metoclopramide; Granisetron; Dexamethasone; Tablets

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Azabicyclo Compounds; Aza Compounds; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Study Officials

• C.A.H.H.V.M. Verhagen, M.D. Ph.D.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christa v Schaik

CONTACT

024-3610353; christa.vanschaik@radboudumc.nl

C.A.H.H.V.M. Verhagen, M.D. Ph.D.

CONTACT

024-3610353; Stans.verhagen@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Last Updated: January 11, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share