Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care (ProTreat)

This is an interventional treatment trial for Nausea Read More

Inclusion Criteria:

1. Patients aged ≥18 years
2. Opioid naïve (no opioids intake within last 72 hours) patients in whom opioid therapy (WHO III) is started to treat cancer pain;
3. Palliative (not curable) cancer pain patients;
4. The latest laboratory values before registration meet the following criteria: Potassium within normal range: 3,5 - 5,1 mmol/l;
5. Patients must have a score for nausea on a 0-10 numeric rating scale (NRS) < 3 at screening visit;
6. Patients under risk for QT prolongation (e.g. history of cardiac disease, receiving concomitant medication known to cause QT-prolongation, electrolyte abnormalities must show an Electrocardiogram with no QTc prolongation (QTc men> 460 msec; women >440msec);
7. Written informed consent obtained according to international guidelines and local laws;
8. Ability of patient to understand nature, importance, and individual consequences of clinical trial;
9. Patients must be able to adhere to the study visit schedule and other protocol requirements.

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 if they had other known acute reasons for nausea and/or emesis, e.g.:

   1. were undergoing chemotherapy < 72 h before or during the study treatment period;
   2. were undergoing radiotherapy to the skull or abdomen < 72 h before or during the study treatment period;
   3. were undergoing surgical procedures or non-invasive procedures under general anaesthesia < 72 h before or during the study treatment period;
   4. a score for nausea on a 0-10 numeric rating scale ≥ 3 at screening visit;
   5. other reason;
4. Patients with contraindications or hypersensitivity to opioids or palonosetron, fructose, soya, lactose or peanut intolerance;
5. Patients unable to take oral medications;
6. Patients undergoing dialyses treatment;
7. Known or persistent abuse of medication, drugs, or alcohol;
8. Current or planned pregnancy, nursing period;

9. 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:

   1. Oral hormonal contraception ('pill')
   2. Dermal hormonal contraception
   3. Vaginal hormonal contraception (NuvaRing®)
   4. Contraceptive plaster
   5. Long-acting injectable contraceptives
   6. Implants that release progesterone (Implanon®)
   7. Tubal ligation (female sterilisation)
   8. Intrauterine devices that release hormones (hormone spiral)
   9. 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.

10. 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;
11. 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;
12. Persons who are in a relationship of dependence/employment with the sponsor or the investigator will be excluded.