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Pain | Conversion From Parenteral to Oral Methadone.

Pain research study

What is the primary objective of this study?

The majority of current studies regarding the use of methadone (MTD) in the treatment of cancer pain are focused in its administration via the oral route (PO). The ratio considered from VO to parenteral route (BP) is 2:1. Academic literature assumes the ratio from BP to VO to be 1:2. In our unit, we use MTD in the context of ROP and not as the last opioid. If face with a situation where there is a good control of pain with MTD BP, usually we move to VO. We have observed that the traditional ratio tend to produce certain toxicity problems. Because of this, we have proposed a new ratio of conversion from PAR MTD to oral MTD, i.e. 1:1.2

Who is eligible to participate?

Inclusion Criteria: - diagnosis of advanced disease of any type of malignancy; - >18 years old at the time of inclusion; - for inclusion in the screening phase, the patient is a candidate to pass parenteral methadone to oral methadone (MTD) following to the physician criteria. - for inclusion in the assessment phase should follow: presence of cancer pain controlled with no significant toxicity with MTD VP for 48h. Be considered controlled pain and absence of significant toxicity due to MTD, as the definitions given in the general protocol; e) signing the informed consent form. Exclusion Criteria: 1. impairment cognitive status that interferes with the assessment; 2. diagnosis of psychiatric disorders at the time of recruitment that alters the ability to evaluate; 3. presence of side effects due to chemotherapy and / or radiotherapy prior to the change of route of administration, taking into account the following two criteria: - For patients on a protocol of successive cycles of chemotherapy (no change in chemotherapy regimen), having presented side effects due to chemotherapy in the 15 days prior to the change of route of administration as clinically and following the recommendations of the 2011 4th ed Oncomecum of the Spanish Society of Medical Oncology and deemed that may interfere with the assessment of the primary endpoint. - For patients starting a new protocol of chemotherapy or radiotherapy, have submitted side effects due to such treatment in the 28 days prior to the change of route of administration based on clinical judgment and following the recommendations of the Oncomecum 2011 4th ed. of the Spanish Society of Medical Oncology and deemed that may interfere with the assessment of the primary endpoint. 4. invasive anesthesic techniques have been made during the 3 days before changing to oral parenteral; 5. patients at agony.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Parenteral /oral methadone ratio 1:2See "arm/group descriptions"

Drug:Parenteral /oral methadone ratio 1:1.2See "arm/group descriptions"

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Parenteral /oral methadone ratio 1:2Far advanced cancer patients with cancer pain hospitalized, and treated with PMTD undergo a preliminary 48 hours observation phase. Blinded evaluators assess pain management and treatment toxicity and determine an OPTIMISED DOSE of parenteral METHADONE (pain control without toxicity) for each patient. Only patients with a correct control of pain and without significant toxicity throughout this period are eligible for randomization. INTERVENTION: Patients randomized to this arm will receive the double of OPTIMISED DOSE of parenteral METHADONE, orally every 24h in 3 administrations during the following 3 days.

Parenteral /oral methadone ratio 1:1.2Far advanced cancer patients with cancer pain hospitalized, and treated with PMTD undergo a preliminary 48 hours observation phase. Blinded evaluators assess pain management and treatment toxicity and determine an OPTIMISED DOSE of parenteral METHADONE (pain control without toxicity) for each patient. Only patients with a correct control of pain and without significant toxicity throughout this period are eligible for randomization. INTERVENTION: Patients randomized to this arm will receive the following Oral Methadone dose: 20% increase of optimised parenteral methadone dose every 24h in 3 administrations during the following 3 days.

Study Status

Completed

Start Date: August 2011

Completed Date: June 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Proportion of intoxicated patients in each groups

Secondary Outcome: Parenteral/oral MTD final ratio in patients considered as "failure"

Study sponsors, principal investigator, and references

Principal Investigator: JESÚS GONZÁLEZ-BARBOTEO, MD

Lead Sponsor: L'Hospitalet de Llobregat

Collaborator: Hospital Arnau de Vilanova

More information:https://clinicaltrials.gov/show/NCT01836328

González-Barboteo J, Porta-Sales J, Sánchez D, Tuca A, Gómez-Batiste X. Conversion from parenteral to oral methadone. J Pain Palliat Care Pharmacother. 2008;22(3):200-5.

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