Treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid. MedDRA version: 14.0 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: METHADONE AP-HP 5 mg, gélule
Product Name: METHADONE AP-HP 5 mg, gélule
Pharmaceutical Form: Capsule
INN or Proposed INN: METHADONE
CAS Number: 1095-90-5
Other descriptive name: METHADONE
Sponsors
Laboratoires Bouchara-Recordati
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patient of at least 18 years of age 2. Patient suffering from cancer disease, undergoing chemotherapy treatment or not 3. Patient presenting nociceptive or mixed pains inadequately relieved with level 3 opioids (morphine, oxycodone, transdermal fentanyl, hydromorphone) with a numeric pain scale score =5 evidence-based or presenting intolerable side effects with level 3 opioids 4. Patient undergoing level 3 opioid treatment (morphine sulphate or morphine chlorhydrate or fentanyl or oxycodone or hydromorphone) 5. Patient presenting a good understanding of the study objectives and able to give his/her written consent 6. Patient able to communicate with the investigator or his representative 7. Patient available during the whole course of the study and agreeing the study requirements 8. Patient with Social Insurance 9. Patient having received patient’s information form, orally informed and having signed the consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: 1. Patient in terminal cancer disease (life expectancy less than 2 months) according to investigator’s judgement 2. Patient treated with a medication that may result in an interaction with methadone, such as: antiarrythmic treatments (Ia or III), erythromycin, spiramycin, intravenous vincamin 3. Patient receiving opioid treatment for any other reason than pain 4. Patient unable to swallow the study treatment 5. Patient presenting contra-indication to the use of methadone 6. Patient having a decompensated respiratory failure or a severe hepatic disease 7. Patient having a known hypersensitivity to methadone 8. Patient presenting QT interval prolongation on ECG results 9. Patient receiving a concomitant treatment with a morphine-type agonist-antagonist medication (pentazocine, buprenorphine, nalbuphine) or with sultropide 10. Patient treated by radiotherapy within 15 days before inclusion 11. Patient participating or having participated in another clinical trial with a new therapy within 1 month before inclusion 12. Patient with a history of substance abuse 13. For woman with childbearing potential: pregnancy or breastfeeding. 14. Forfeiture of freedom or under guardianship 15. Past history of suicidal attempts 16. Patient likely not to respect the study conditions and/or study discontinuation criteria according to investigator’s judgement 17. Patient presenting any other medical condition or illness or clinically significant abnormal findings on the physical examination at screening that, in the opinion of the Investigator, make the patient unsuitable for the study or put the patient at additional risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate clinical effects (success/failure) after level 3 opioids switch to methadone in patients with cancer-related pain inadequately relieved or with intolerable side effects.;Secondary Objective: The secondary objectives are: - Overall safety of methadone during the study (adverse reactions related to methadone and withdrawal symptoms) - To describe the patients’ characteristics - To describe the effects of methadone on pain relief - To describe the methadone administration - To evaluate patient’s quality of life - To evaluate the prescriber’s opinion regarding the handling of methadone initiation. ;Primary end point(s): The binary main criterion is based on success/failure rate related to methadone switch on D4. The success is defined as the adequate pain relief on D4 and no occurrence of overdose between D1 and D4. All unmet definitions of success are considered as failures. The adequate pain relief is defined as the composite criterion: - Decrease of at least 2 points on the numeric pain scale score from 0 (no pain) to 10 (unacceptable pain) evaluated on D4 when compared to the numeric pain scale score at baseline, - And a numeric pain scale score <5 during two consecutive days (between D1 and D4). ;Timepoint(s) of evaluation of this end point: The success/failure rate after the switch to methadone will be compared at D4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following parameters will be considered as secondary evaluation parameters: Safety of methadone: 1 - Adverse event and SAE (type, intensity and number) related to methadone during the study 2 - Evaluation of Handelsman scores assessing the withdrawal syndrome 3 - Percentage of patients with a withdrawal syndrome, if applicable 4 - Change in QT interval 5 - Description of patients’ characteristics (sex, age, primary cancer disease location and metastases, ECOG performance status, previous/current opioid treatments for pain, adverse reactions related to the previous opioid treatment, current anti-cancer treatment) Effects of methadone on pain relief: 6 - Pain intensity with the numeric pain scale 7 - Pain intensity and pain interference scores from the BPI questionnaire 8 - Percentage of subjects with adequate pain relief 9 - Time to obtain pain relief Methadone administration: 10 - Mean doses of methadone 11 - Mean number and intensity of breakthrough pain episodes 12 - Number of interdoses for the group “patient-controlled dose”(Group A) 13 - Number of additional doses of methadone for the group “fixed dose” (Group B) 14 - Number of methadone dose adjustment for the group “patient-controlled dose” (Group A) 15 - Mean methadone stabilised dose (defined as a stable dose of methadone for at least two days and less than 4 breakthrough pain episodes per day) 16 - Time to achieve dose stabilization of methadone 17 - Description of adjuvant pain medications and rescue Quality of life: 18 - Quality of life improvement evaluated with EORTC QLQ-C30 quality of life scale Prescriber’s opinion: 19 - Prescriber’s opinion regarding the handling of methadone initiation ;Timepoint(s) of evaluation of this end point: The following parameters will be considered as secondary evaluation parameters: Safety of methadone: 1 - overall evaluation 2 - overall evaluation 3 - overall evaluation 4 - between D1 and D7 5 – at ba | — |
Countries
France
Contacts
Public ContactMedical Direction
Laboratoires Bouchara-Recordati
Outcome results
None listed