NauseaPhase 2ProTreatNCT05315999
Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care
A Phase 2 study testing Palonosetron Hydrochloride in people with Nausea and Vomiting, run by Gerhild Becker at 1 site in Germany.
Trial summary
Palliative cancer patients with tumor pain often suffer from nausea and vomiting when starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Palonosetron Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2022to 18 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Palliative Care, Medical Center, University of Freiburg
Freiburg im Breisgau, D-79106
About this study
Official title: Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: a Randomized Controlled Phase II Feasibility Trial
Palliative cancer patients with tumor pain often suffer from nausea and vomiting when starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced nausea and vomiting.
Read the detailed description
Pain is one of the most common and debilitating symptoms in patients with advanced cancer and opioids are the main stay of treatment for cancer pain. However, initiation of opioid-therapy is frequently hindered by OINV. OINV is a highly distressing symptom and can affect medication compliance, enteral absorption, and quality of life.This Phase II feasibility study is conducted to assess the feasibility of the prophylactic antiemetic treatment of OINV with palonosetron in comparison to placebo. The objective is to investigate the feasibility of patient recruitment and implementation of the study design as well as to obtain an initial estimate of the antiemetic efficacy and safety of prophylactic treatment of OINV with palonosetron compared to placebo. A total of 30 palliative patients starting an opioid-therapy (WHO II \& III) for cancer pain will be randomly assigned to receive either a single dose of placebo or palonosetron. Safety and efficiency assessment are based on patient reports regarding OINV, pain and safety parameters during the following 6 days.
- Conditions
- Nausea, Vomiting, Pain, Advanced Cancer
- Being tested
- Palonosetron Hydrochloride, Placebo
- Medical subject headings
- Nausea, Vomiting, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palonosetron HydrochlorideDrug
Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III)
PlaceboDrug
Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III)
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron Hydrochloride | Experimental | Palonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III) Receives: Drug: Palonosetron Hydrochloride |
| Placebo | Placebo comparator | Placebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the study design
Rates of patient recruitment per month, screening failures, drop-out from the trial.
Measured: 12 months
Number of patients who show no relevant increase of nausea
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
Measured: day 1 to day 6
Secondary outcomes (11)
Complete response of OINV
Complete response defined as no emetic episodes, no nausea, no rescue anti-emetic. Comparing Palonosetron treatment with placebo
Measured: day 1 to day 6
Time to OINV
Time to emetic episodes or nausea or rescue antiemetic after randomisation, comparing Palonosetron treatment with placebo
Measured: day 1 to day 6
Nausea
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).
Measured: day 1 to day 6
Vomiting
Occurrence of vomiting, comparing Palonosetron treatment with placebo
Measured: day 1 to day 6
Pain control
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)
Measured: day 1 to day 6
Rescue anti-emetics
The use of rescue anti-emetics, comparing Palonosetron treatment with placebo
Measured: day 1 to day 6
Participant's burden by nausea, pain, constipation and headache
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
Measured: day 1 to day 6
Severity of constipation
Stool consistency and frequency, bowel function index (BFI)
Measured: day1 and day 6
Symptom preferences
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.
Measured: 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.
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.
Measured: day 1 to day 6
Patient satisfaction with the study drug
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.
Measured: day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start3 May 2022
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerhild Becker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gerhild Becker, University Hospital Freiburg
- Investigators
- Gerhild Becker, Prof. Dr. med., Study chair, Clinic for Palliative Care, Medical Center, University of Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315999
- Sponsor's protocol ID
- P003161
- Acronym
- ProTreat
- Status last verified
- Dec 2024
- First submitted
- 2 Mar 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: a Randomized Controlled Phase II Feasibility Trial
- ClinicalTrials.gov ID
- NCT05315999
- Acronym / sponsor ID
- ProTreat / P003161
- Conditions
- Nausea, Vomiting, Pain, Advanced Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gerhild BeckerUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palliative cancer patients with tumor pain often suffer from nausea and vomiting when starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced nausea and vomiting.
Detailed description
Pain is one of the most common and debilitating symptoms in patients with advanced cancer and opioids are the main stay of treatment for cancer pain. However, initiation of opioid-therapy is frequently hindered by OINV. OINV is a highly distressing symptom and can affect medication compliance, enteral absorption, and quality of life.This Phase II feasibility study is conducted to assess the feasibility of the prophylactic antiemetic treatment of OINV with palonosetron in comparison to placebo. The objective is to investigate the feasibility of patient recruitment and implementation of the study design as well as to obtain an initial estimate of the antiemetic efficacy and safety of prophylactic treatment of OINV with palonosetron compared to placebo. A total of 30 palliative patients starting an opioid-therapy (WHO II \& III) for cancer pain will be randomly assigned to receive either a single dose of placebo or palonosetron. Safety and efficiency assessment are based on patient reports regarding OINV, pain and safety parameters during the following 6 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron Hydrochloride | Experimental | Drug: Palonosetron HydrochloridePalonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palonosetron HydrochloridePalonosetron (500µg): single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III) | Drug | Palonosetron Hydrochloride |
| PlaceboPlacebo: single dose per os 1-2 hours before the start of opioid-therapy (WHO II \& III) | Drug | Placebo |
Primary outcome
Feasibility of the study design
Time frame: 12 months
Rates of patient recruitment per month, screening failures, drop-out from the trial.
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
11 secondary outcomes
Complete response of OINV
Time frame: day 1 to day 6
Time to OINV
Time frame: day 1 to day 6
Nausea
Time frame: day 1 to day 6
Vomiting
Time frame: day 1 to day 6
Pain control
Time frame: day 1 to day 6
Rescue anti-emetics
Time frame: day 1 to day 6
Participant's burden by nausea, pain, constipation and headache
Time frame: day 1 to day 6
Severity of constipation
Time frame: day1 and day 6
Symptom preferences
Time frame: 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
Patient satisfaction with the study drug
Time frame: day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhild Becker, Prof. Dr. med. study chair
Clinic for Palliative Care, Medical Center, University of Freiburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palonosetron Hydrochloride in people with Nausea and Vomiting, run by Gerhild Becker at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study design (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.