Symptoms and General Pathology

All Conditions

Nausea

Vomiting

Signs and Symptoms, Digestive

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Cardiotonic Agents

Dexamethasone

Dexamethasone acetate

Metoclopramide

Granisetron

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

Serotonin

Serotonin 5-HT3 Receptor Antagonists

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.

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 The granisetron patch will only be withdrawn from patients that suffer from clinically relevant toxicity.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.

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

metoclopramide

granisetron patch 3.1mg/24 hours, use until toxicity

granisetron

dexamethasone 8 mg, last step in both algorithms

Granisetron 2Mg Tablet

Christa v Schaik

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

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.

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.

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

number of included patients a 6 months period

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

The time from T0 until the moment that nausea and vomiting/retching is in control

Radboud University Medical Center

Emetics

Palonosetron

Cisplatin

1st cycle Palonosetron, 2nd cycle Granisetron

1st cycle Granisetron, 2nd cycle Palonosetron

3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Shiying Yu, MD

This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.

The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

Jiangsu Simcere Pharmaceutical Co., Ltd.

Epirubicin

receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)

receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.

palonosetron

receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.

This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.

An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients

Xijing Hospital

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Lymphoma, Mantle-Cell

Graft vs Host Disease

Leukemia, Mast-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Mastocytosis

Mastocytosis, Systemic

Mast Cell Activation Disorders

Chronic Graft Versus Host Disease

Lymphosarcoma

Mantle Cell Lymphoma

Homologous Wasting Disease

Acute Graft Versus Host Disease

Antipyretics

Analgesics

Antirheumatic Agents

Anti-Infective Agents

Dermatologic Agents

Neuroprotective Agents

Anti-Allergic Agents

Central Nervous System Depressants

Other Dietary Supplements

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Acetaminophen

Rituximab

Cyclosporine

Cyclosporins

Prednisolone

Lenograstim

Mycophenolic Acid

Thymoglobulin

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Diphenhydramine

Promethazine

Benzocaine

Antilymphocyte Serum

Antineoplastic Agents, Immunological

Immunologic Factors

Adjuvants, Immunologic

Enzyme Inhibitors

Immunosuppressive Agents

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

Analgesics, Non-Narcotic

Protective Agents

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Tannic Acid

Rituximab will be infused after a non-myeloablative transplantation regimen of total lymphoid irradiation (TLI) + anti-thymoglobulin (ATG), with the intention of reducing chronic graft-vs-host disease (cGvHD)

Total lymphoid irradiation (TLI) administered at 80cGy for 10 days

Total lymphoid irradiation

Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.

Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg.

Anti-thymoglobulin, rabbit (ATG, rabbit ATG)

Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates \> 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week).

Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete

Mycophenylate mofetil

Filgrastim provided as needed for neutrophil support

Filgrastim

Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI

Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)

Solumedrol

Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC

Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC

Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC

David Miklos

To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of chronic graft-vs-host disease (cGvHD).

Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation

The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)

Subjects who Relapsed following after Allogeneic HSCT

Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse.

The Leukemia and Lymphoma Society

National Cancer Institute (NCI)

Stanford University

Assistant Professor of Medicine

Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Prophylactic Rituximab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

CLL- Chronic Lymphocytic Leukemia

MCL- Mantle Cell lymphoma

unknown or Not Reported

Patient Disease characteristics

David Miklos, MD, PhD; Associate Professor of Medicine (Blood and Marrow Transplantation)

35 total participants were analyzed. No data is available for the withdrawn participant.

Chronic Graft-vs-Host Disease (cGvHD)

Incidence of Relapse

Mortality within 100 days, all causes

Nonrelapse mortality within 1 year

Relapse + mortality within 1 year

Mortality

CLL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Prophylactic Rituximab (CLL Patients)

MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment Algorithm for Nausea and Vomiting in the Palliative Phase	NCT03017391	Nausea Vomiting Cancer	metoclopramide granisetron Dexamethasone Granisetron 2Mg...	18 Years -	Radboud University Medical Center
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy	NCT01909856	Cancer	Palonosetron Granisetron Dexamethasone Cisplatin	18 Years - 90 Years	Jiangsu Simcere Pharmaceutical Co., Ltd.
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients	NCT00666783	Chemotherapy-In...	palonosetron Granisetron	18 Years - 70 Years	Xijing Hospital
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD	NCT00186628	Leukemia, Mast-... Mantle-cell Lym...	Total lymphoid ... Rituximab Anti-thymoglobu... Cyclosporine Mycophenylate m... Filgrastim Granisetron Solumedrol Acetaminophen Diphenhydramine Hydrocortisone	18 Years - 76 Years	Stanford University
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma	NCT00450801	Lymphoma	Rituximab Cyclophosphamid... Cytarabine Doxorubicin Etoposide Ifosfamide Leucovorin Methotrexate Thalidomide Vincristine Mesna Filgrastim (G-C... Granisetron Decadron	18 Years -	University of Miami
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation	NCT01536392	Cancer of the C...	Granisetron Ondansetron Questionnaires Study Drug Diar...	18 Years -	M.D. Anderson Cancer Center
Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients	NCT00450853	Vomiting	granisetron	18 Years -	Clinica Universidad de Navarra, Universidad de Navarra
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation	NCT01536392	Cancer of the C...	Granisetron Ondansetron Questionnaires Study Drug Diar...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for granisetron

Every month we try and update this database with for granisetron cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for granisetron

Every month we try and update this database with for granisetron cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for granisetron cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.