Treatment Algorithm for Nausea and Vomiting in the Palliative Phase
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| ClinicalTrials.gov Identifier: NCT03017391 |
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Recruitment Status : Unknown
Verified December 2016 by Radboud University.
Recruitment status was: Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nausea Vomiting Cancer | Drug: metoclopramide Drug: granisetron Drug: Dexamethasone Drug: Granisetron 2Mg Tablet | Phase 4 |
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 (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2017 |
| Estimated Primary Completion Date : | April 2018 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 Name: Sancuso Drug: Dexamethasone dexamethasone 8 mg, last step in both algorithms Drug: Granisetron 2Mg Tablet granisetron 2 mg loading dose |
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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 Name: Sancuso Drug: Dexamethasone dexamethasone 8 mg, last step in both algorithms Drug: Granisetron 2Mg Tablet granisetron 2 mg loading dose |
- 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
- days from T0 to control [ Time Frame: two weeks ]The time from T0 until the moment that nausea and vomiting/retching is in control
- feasibility [ Time Frame: 6 months ]number of included patients a 6 months period
- 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
- quality of life [ Time Frame: 15 days ]QLQC30 scale
- adverse events [ Time Frame: 14/15 days ]diary adverse events
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017391
| Contact: Christa v Schaik | 024-3610353 | christa.vanschaik@radboudumc.nl | |
| Contact: C.A.H.H.V.M. Verhagen, M.D. Ph.D. | 024-3610353 | Stans.verhagen@radboudumc.nl |
| Principal Investigator: | C.A.H.H.V.M. Verhagen, M.D. Ph.D. | Radboud University |
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT03017391 History of Changes |
| Other Study ID Numbers: |
CVS01 |
| First Posted: | January 11, 2017 Key Record Dates |
| Last Update Posted: | January 11, 2017 |
| Last Verified: | December 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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palliative care palliative medicine palliative |
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Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone Dexamethasone acetate Metoclopramide Granisetron BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Serotonin Antagonists Serotonin Agents |