Conversion From Parenteral to Oral Methadone.
Information source: L'Hospitalet de Llobregat
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Parenteral /oral methadone ratio 1:2 (Drug); Parenteral /oral methadone ratio 1:1.2 (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: L'Hospitalet de Llobregat Official(s) and/or principal investigator(s): JESÚS GONZÁLEZ-BARBOTEO, MD, Principal Investigator, Affiliation: INSTITUT CATALÀ D'ONCOLOGIA. HOSPITAL DURAN I REYNALS
Overall contact: JESÚS GONZÁLEZ-BARBOTEO, MD, Phone: 0034932607789, Email: jgonzalez@iconcologia.net
Summary
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
Clinical Details
Official title: Prospective Randomized Simple Blinded Study Comparing Two Conversion Ratios From Parenteral to Oral Methadone in Patients With Cancer Pain.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Proportion of intoxicated patients in each groups
Secondary outcome: Parenteral/oral MTD final ratio in patients considered as "failure"
Detailed description:
OBJECTIVE: To compare the different ratios of conversion from MTD VP to MTD PO. To verify
the presence of lower toxicity in the ratio 1: 1. 2 against 1: 2 while still maintaining a good
control of pain in patients with advanced cancer that are hospitalized in different
palliative care units.
METHODOLOGY: Prospective randomized single blind study in patients with cancer pain treated
with parenteral MTD and that would move into MTD oral provided there is good control of
pain. The patients will be randomly split into two groups: (Group A = ratio 1: 1. 2 and Group
B=ratio 1: 2). Patients will be evaluated during the two days before the switch is applied,
the day of the change and during the 3 days post-ROP. The patients who display significant
toxicity and/or bad analgesic control within the first 72 hours post-ROP will be considered
negative cases. The size of the sample required will include 44 patients distributed in
balanced groups in order to obtain a size effect of 45% and a statistical power of 80%. The
significance level will be 0. 05 for two tails.
STATISTIC ANALYSIS: By means of Chi-squared to compare the proportion of Opioid Rotation
(OR) failure in both groups of study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
JESÚS GONZÁLEZ-BARBOTEO, MD, Phone: 0034932607789, Email: jgonzalez@iconcologia.net
Hospital Arnau de Vilanova, Lleida 25198, Spain; Recruiting MARÍA NABAL-VICUÑA, PHD, Phone: 0034973240100, Ext: 5243, Email: mnabal@secpal.com MARÍA NABAL-VICUÑA, PHD, Principal Investigator JAUME CANAL-SOTELO, MD, Sub-Investigator
Hospital Universitario La Paz, Madrid 28046, Spain; Recruiting Leyre Díez Porres, PhD, Phone: 003491 727 70 57, Email: ldiezporres@gmail.com Leyre Diez Porres, PhD, Principal Investigator Alberto Alonso Babarro, MD, Sub-Investigator Yolanda Vilches, MD, Sub-Investigator
Institut Català D'Ncologia. Hospital Duran Y Reynals, L'hospitalet de Llobregat, Barcelona 08907, Spain; Recruiting JESÚS GONZÁLEZ-BARBOTEO, MD, Phone: 0034932607789, Email: jgonzalez@iconcologia.net JESÚS GONZÁLEZ-BARBOTEO, MD, Principal Investigator JOSEP PORTA-SALES, PHD, Sub-Investigator CRISTINA GARZÓN-RODRÍGUEZ, PHD, Sub-Investigator
Additional Information
Related publications: 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.
Starting date: August 2011
Last updated: April 9, 2015
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