Overview

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

Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gerhild Becker
Treatments:
Palonosetron
Criteria
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.