Clinical trial NCT03017391: Treatment Algorithm for Nausea and Vomiting in the Palliative Phase
Official title: Feasibility Study to Compare 2 Strategies of Treatment Algorithm for Treating Nausea and or Vomiting in the Palliative Phase of Cancer Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nausea
Vomiting
Cancer
Keywords: palliative care
palliative medicine
palliative
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NRS nausea
timeFrame: 15 days
Secondary outcomes:
measure: days from T0 to control
timeFrame: two weeks
Other outcomes:
measure: feasibility
timeFrame: 6 months
measure: comparison of starting metoclopramide to starting with granisetron
timeFrame: 6 months
measure: quality of life
timeFrame: 15 days
measure: adverse events
timeFrame: 14/15 days
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: C.A.H.H.V.M. Verhagen, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: