Treatment Algorithm for Nausea and Vomiting in the Palliative Phase

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03017391
• Other study ID #: CVS01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 21, 2016
• Last updated: January 9, 2017
• Start date: January 2017

Study information

• Verified date: December 2016
• Source: Radboud University
• Contact: Christa v Schaik
• Phone: 024-3610353
• Email: christa.vanschaik[@]radboudumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Nausea
• Vomiting

Intervention

Drug:
• metoclopramide
metoclopramide 10 mg tablets 3x daily orally or suppositories 10 mg 3x daily rectally, use until toxicity
• granisetron
granisetron patch 3.1mg/24 hours, use until toxicity
• Dexamethasone
dexamethasone 8 mg, last step in both algorithms
• Granisetron 2Mg Tablet
granisetron 2 mg loading dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	feasibility	number of included patients a 6 months period	6 months	No
Other	comparison of starting metoclopramide to starting with granisetron	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	No
Other	quality of life	QLQC30 scale	15 days	No
Other	adverse events	diary adverse events	14/15 days	No
Primary	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	No
Secondary	days from T0 to control	The time from T0 until the moment that nausea and vomiting/retching is in control	two weeks	No