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RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Cancer, Cancer Pain

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Trial Information

RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.


Inclusion Criteria:



- patients with diagnostic (histological or cytological) evidence of locally advanced
or metastatic solid tumour;

- with average pain intensity ≥ 4, measured with NRS and related to the last 24
hours, due to the cancer, requiring for the first time an analgesic treatment with
3rd step/WHO opioids

- with life expectancy > one month

- "strong" opioid naïve;

- eligible to take any of the medications under evaluation, by TDS or by mouth;

- with age ≥ 18 years;

Exclusion Criteria:

- Patients recruited in other researches that conflict or may confound the conduction
and results of the present study;

- Lack of informed consent;

- with presence of other diseases, including psychiatric/mental illness, severe senile
or other form of dementia, that can interfere with participation and compliance with
the study protocol or can contraindicate the use of the investigational drugs;

- with presence of co-morbidities, which could create potentially dangerous drug
interactions with opioids (eg, use of macrolide antibiotics or antifungal,….);

- any kind of contraindications to the use of opioid drugs;

- Patients with a known story, past or current, of drugs abuse or addiction;

- Use of drugs which presents a combination of opioids and other molecule (as NSAIDs,
paracetamol, naloxone, ..);

- Patients who cannot guarantee regular follow-up visits for logistic or geographic
reasons;

- Need of starting 3rd step treatment in an "emergency clinical situation" that do not
allow the correct procedures of randomization;

- diagnosis of primary brain tumor or leukaemia;

- diagnosis of chronic renal failure;

- patients with antalgic radiotherapy or radio-metabolic therapy in progress or
completed less than 14 days before study;

- patients starting a first line chemotherapy simultaneously to the beginning of the
study;

- other types of analgesic treatments, including local-regional anesthetic techniques
or neurosurgical /ablative methods.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Non-Responder (NR) patients

Outcome Description:

Evaluation of the proportion of Non-Responder (NR) patients. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity "stable" or "worsened" at day 28 compared with baseline values.

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Oscar Corli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mario Negri Institute of Pharmacological Research - IRCCS

Authority:

Italy: The Italian Medicines Agency

Study ID:

Studio CERP

NCT ID:

NCT01809106

Start Date:

April 2011

Completion Date:

April 2014

Related Keywords:

  • Cancer
  • Cancer Pain
  • cancer pain
  • major opioid
  • analgesics

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