Skip to content

Treatment Algorithm for Nausea and Vomiting in the Palliative Phase

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03017391
Enrollment
20
Registered
2017-01-11
Start date
2017-01-31
Completion date
Unknown
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Nausea, Vomiting

Keywords

palliative care, palliative medicine, palliative

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.

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.

Interventions

DRUGmetoclopramide

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

DRUGgranisetron

granisetron patch 3.1mg/24 hours, use until toxicity

DRUGDexamethasone

dexamethasone 8 mg, last step in both algorithms

DRUGGranisetron 2Mg Tablet

granisetron 2 mg loading dose

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
NRS nausea15 daysresponse defined as NRS \<3 or decrease of more than 2 on NRS and absence of vomiting or retching in the last 3 days

Secondary

MeasureTime frameDescription
days from T0 to controltwo weeksThe time from T0 until the moment that nausea and vomiting/retching is in control

Other

MeasureTime frameDescription
feasibility6 monthsnumber of included patients a 6 months period
comparison of starting metoclopramide to starting with granisetron6 monthsresponse defined as NRS \<3 or decrease of more than 2 on NRS and absence of vomiting or retching in the last 3 days
quality of life15 daysQLQC30 scale
adverse events14/15 daysdiary adverse events

Contacts

Primary ContactChrista v Schaik
christa.vanschaik@radboudumc.nl024-3610353
Backup ContactC.A.H.H.V.M. Verhagen, M.D. Ph.D.
Stans.verhagen@radboudumc.nl024-3610353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026