- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315999
Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care (ProTreat)
Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: A Randomized Controlled Phase II Feasibility Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Arlette Tais, Dr.
- Phone Number: +49 761 270-77840
- Email: arlette.tais@uniklinik-freiburg.de
Study Locations
-
-
-
Freiburg, Germany, D-79106
- Recruiting
- Clinic for Palliative Care, Medical Center, University of Freiburg
-
Contact:
- Gerhild Becker, Prof.
- Phone Number: +49 761 270 - 95412
- Email: gerhild.becker@uniklinik-freiburg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged ≥18 years
- Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy (WHO II & III) is started to treat cancer pain;
- Palliative (not curable) cancer pain patients;
- Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) < 3 at screening visit;
- Written informed consent obtained according to international guidelines and local laws;
- Ability of patient to understand nature, importance, and individual consequences of clinical trial;
- Patients must be able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
- Patient's death is imminent (judged by the "surprise" question of the treating physician or nurse: "Would you be surprised if this patient died within the next 7 days?"); If the answer is "no", trial subject cannot participate;
- Participation in the trial considered inappropriate based on the patient's physical, social, psychological, or spiritual condition (judgement of treating physician or nurse);
- Patients receiving antiemetic treatment within the last 72 h before study treatment period
- Patients if they are known to start a treatment causing acute nausea and/or emesis during study period
- Patients with contraindications or hypersensitivity to opioids or palonosetron, fructose, soya, lactose or peanut intolerance;
- Patients unable to take oral medications or patients receiving medication via PEG-tube;
- Patients undergoing dialyses treatment;
- Known or persistent abuse of medication, drugs, or alcohol;
- Current or planned pregnancy, nursing period;
Patients who are sexually active and unwilling to use highly effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly effective:
- Oral hormonal contraception ('pill')
- Dermal hormonal contraception
- Vaginal hormonal contraception (NuvaRing®)
- Contraceptive plaster
- Long-acting injectable contraceptives
- Implants that release progesterone (Implanon®)
- Tubal ligation (female sterilisation)
- Intrauterine devices that release hormones (hormone spiral)
- Double barrier methods This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, and female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
Except: Female patients who are surgically sterilised by hysterectomy or who are expected to be postmenopausal are eligible for this trial. A lack of menstruation of at least 12 months will be considered as a proof to be postmenopausal.
Men must agree to use a latex condom during sexual contact with females of childbearing potential while participating in this study even if they have undergone a successful vasectomy.
Patients must abstain from donating blood, semen, or sperm during participation in the study.
- Simultaneous participation in any other interventional clinical trial within the last 14 days before the start of this trial; simultaneous participation in registry and diagnostic trials is allowed;
- Patients without legal German language capacity who are unable to understand the nature, significance and consequences of the trial or any other co-existing medical or psychological condition that will preclude participation in the study;
- Persons who are in a relationship of dependence/employment with the sponsor or the investigator will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Palonosetron Hydrochloride
Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II & III)
|
Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II & III)
|
Placebo Comparator: Placebo
Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II & III)
|
Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II & III)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the study design
Time Frame: 12 months
|
Rates of patient recruitment per month, screening failures, drop-out from the trial.
|
12 months
|
Number of patients who show no relevant increase of nausea
Time Frame: day 1 to day 6
|
Number of patients who show no relevant increase of nausea after starting opioid therapy at any of the following 6 days.
Nausea scores are assessed on an increasing 11-point numeric rating scale (NRS) from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS).
Relevant is an increase on this NRS ≥1, which reflects the minimal clinically important difference (MCID) for nausea
|
day 1 to day 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response of OINV
Time Frame: day 1 to day 6
|
Complete response defined as no emetic episodes, no nausea, no rescue anti-emetic.
Comparing Palonosetron treatment with placebo
|
day 1 to day 6
|
Time to OINV
Time Frame: day 1 to day 6
|
Time to emetic episodes or nausea or rescue antiemetic after randomisation, comparing Palonosetron treatment with placebo
|
day 1 to day 6
|
Nausea
Time Frame: day 1 to day 6
|
Occurrence and severity of nausea rated by the participants on a 11-point numeric rating scale (NRS), comparing Palonosetron treatment with placebo.
Nausea scores are assessed on an increasing 11-point numerical scale from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS).
|
day 1 to day 6
|
Vomiting
Time Frame: day 1 to day 6
|
Occurrence of vomiting, comparing Palonosetron treatment with placebo
|
day 1 to day 6
|
Pain control
Time Frame: day 1 to day 6
|
Daily opioid intake and pain score rated by the participants on a 11-point numeric rating scale (NRS).
Pain scores are assessed on an increasing 11-point numerical scale from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS)
|
day 1 to day 6
|
Rescue anti-emetics
Time Frame: day 1 to day 6
|
The use of rescue anti-emetics, comparing Palonosetron treatment with placebo
|
day 1 to day 6
|
Participant's burden by nausea, pain, constipation and headache
Time Frame: day 1 to day 6
|
Assessed by a questionnaire: Patients are asked to assign the burden of their symptoms to one of 4 categories: not at all, a little, strongly, extremely strongly
|
day 1 to day 6
|
Severity of constipation
Time Frame: day1 and day 6
|
Stool consistency and frequency, bowel function index (BFI)
|
day1 and day 6
|
Symptom preferences
Time Frame: day1 and day 6
|
Patients were asked to rank 5 possible symptoms (tumor pain, nausea, vomiting, constipation, headache) from their most undesired to their most acceptable symptom.
Rated by the participants at day 6 and compared to baseline.
|
day1 and day 6
|
Percentage of participants reporting any grade 3 adverse event (AE) or any serious adverse event (SAE) from patients from the time of the signed ICF to the end of the study.
Time Frame: day 1 to day 6
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. |
day 1 to day 6
|
Patient satisfaction with the study drug
Time Frame: day 6
|
Patients are asked to rate speed of action of the study drug received, the satisfaction with the overall control of nausea and emesis using 4 categories (very satisfied, satisfied, dissatisfied, very dissatisfied) and the and willingness to use the study drug again (yes, no, unknown).
Rated by the participants at day 6.
|
day 6
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gerhild Becker, Prof. Dr. med., Clinic for Palliative Care, Medical Center, University of Freiburg, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Antagonists
- Serotonin 5-HT3 Receptor Antagonists
- Palonosetron
Other Study ID Numbers
- P003161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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