Opioid induced Nausea and Vomiting (OINV)
Conditions
Interventions
Group 1: Palonosetron (500µg): p.o. single dose 1-2 hours before the start of opioid-theraphy
Group 2: Placebo: p.o. single dose 1-2 hours before the start of opioid-theraphy
Sponsors
Universitätsklinikum Freiburg Klinik für Palliativmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged =18 years 2. Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy (WHO II & III) is started to treat cancer pain; 3. Palliative (not curable) cancer pain patients; 4. Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) < 3 at screening visit; 5. Written informed consent obtained according to international guidelines and local laws; 6. Ability of patient to understand nature, importance, and individual consequences of clinical trial; 7. Patients must be able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Participation in the trial considered inappropriate based on the patient's physical, social, psychological, or spiritual condition (judgement of treating physician or nurse); 3. Patients receiving antiemetic treatment within the last 72 h before study treatment period 4. Patients if they are known to start a treatment causing acute nausea and/or emesis during study period 5. Patients with contraindications or hypersensitivity to opioids or palonosetron, fructose, soya, lactose or peanut intolerance; 6. Patients unable to take oral medications or patients receiving medication via PEG-tube; 7. Patients undergoing dialyses treatment; 8. Known or persistent abuse of medication, drugs, or alcohol; 9. Current or planned pregnancy, nursing period; 10. 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: a) Oral hormonal contraception (‘pill’) b) Dermal hormonal contraception c) Vaginal hormonal contraception (NuvaRing®) d) Contraceptive plaster e) Long-acting injectable contraceptives f) Implants that release progesterone (Implanon®) g) Tubal ligation (female sterilisation) h) Intrauterine devices that release hormones (hormone spiral) i) 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. 11. 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; 12. 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; 13. Persons who are in a relationship of dependence/employment with the sponsor or the investigator will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of patient recruitment per month, screening failures, drop-out from the trial, adverse Events/Serious Adverse Events and feasibility of implementation of the study design. Number of patients who show no relevant increase of nausea after starting opioid therapy at any of the following 6 days. Relevant is an increase on a 11-point numeric rating scale (NRS) =1, which reflects the minimal clinically important difference (MCID) for nausea | — |
Secondary
| Measure | Time frame |
|---|---|
| - Complete response (no emetic episodes, no nausea, no rescue anti-emetic) at day 6 - Time to emetic episodes and nausea or rescue antiemetic after randomization - change to baseline in the 11-point numeric rating scale (NRS) for nausea and pain at 6 days after randomization - duration of nausea within 6 days after starting opioid therapy (5 categories), daily assessment by patient for 6 days - Type of nausea within 6 days after starting opioid therapy , daily assessment by patient for 6 days - Daily opioid intake - Patient satisfaction with the study drug, rated by the patient - symptom preferences rated by the patient at day 6 and compared to baseline, rated by the patient emetic episodes - time to emetic episodes developed since randomization - time to rescue antiemetic medication since randomization - time to nausea since randomization - tumor pain: daily assessment for 6 days on an 11-point numeric rating scale (NRS) by the patient - Patient’s burden by nausea, pain, obstipation and headache, daily rating for 6 days by patient - Severity of constipation (stool consistency and frequency, bowel function index), daily assessment by patient for 6 days - Adverse events (AEs) - Serious adverse events (SAEs) Patients complete a daily diary for 6 days after randomization in which they document and assess symptoms. | — |
Countries
Germany
Contacts
Public ContactArlette Tais
Universitätsklinikum FreiburgZentrum Klinische Studien
Outcome results
None listed