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Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain (RER)

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ClinicalTrials.gov Identifier: NCT01946555
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Tracking Information
First Submitted Date September 10, 2013
First Posted Date September 19, 2013
Last Update Posted Date April 14, 2016
Study Start Date September 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2013)
  • Number and duration of episodes of BTcP [ Time Frame: 28 days ]
  • Time to reach the peak of pain in the BTcP [ Time Frame: 28 days ]
  • Maximum intensity of BTcP [ Time Frame: 28 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 16, 2013)
  • Intensity of pain [ Time Frame: 28 days ]
    Evaluate the relationship between the intensity of baseline pain in its various dimensions (worst, average and light on the last 24 hours) and intensity of pain reported during episodes of BTCP;
  • Effect of the treatments [ Time Frame: 28 days ]
    Evaluate over time the effect of the treatments on the rescue BTCP, in terms of reduction of the number that the intensity of the episodes of BTCP
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
Official Title Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
Brief Summary

The BTP (Breakthrough pain)was defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain".

The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough cancer pain). The prevalence of BTcP is equal to 56%.

Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP in the three sub-types: voluntary, non- voluntary and procedural.

The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe changes in the intensity of pain during the day, so it is necessary to differentiate slight fluctuations from the presence of real episodes of BTCP, for which is necessary to use a rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm, present in the literature, to perform the diagnosis of BTCP.

In the presence of BTCP, is important both a correct controlled background pain with major opioids, which can reduce the number and the intensity of the painful episodes, both implement an adjunctive therapy, called "rescue", to be administered at the time which takes over the painful episode using, in this case, an opioid greater.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study involves a longitudinal evaluation of BTCP in cancer patients with pain, through a follow-up of 4 weeks, which will examine in a dynamic clinical aspects (variation over time of the number and duration of episodes, painful intensity, changes in ATC and rescue therapy).
Condition
  • Tumor
  • Cancer Pain
  • Breakthrough Cancer Pain
  • Neuropathic Pain
Intervention
  • Drug: Morphine
  • Drug: Fentanyl
  • Drug: Methadone
  • Drug: Buprenorphine
  • Drug: Oxycodone
  • Drug: Hydromorphone
  • Drug: Tapentadol
Study Groups/Cohorts Worst pain, Average pain
It is necessary that patients are treated for their baseline pain with opioid medications 3rd step (WHO guidelines), having seven different provisions molecules (morphine, methadone, fentanyl, buprenorphine, oxycodone, hydromorphone and tapentadol), and that they receive opioid rescue medication, based on free choice among the options available on the market (in the form of transmucosal fentanyl: OTFC - lollipop, buccal buccal tablets, sublingual tablets, nasal spray in aqueous solution, with pectin nasal spray, morphine or other opioid "oral immediate release" or intravenously).
Interventions:
  • Drug: Morphine
  • Drug: Fentanyl
  • Drug: Methadone
  • Drug: Buprenorphine
  • Drug: Oxycodone
  • Drug: Hydromorphone
  • Drug: Tapentadol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 15, 2015)
150
Original Estimated Enrollment
 (submitted: September 16, 2013)
250
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosis (histologic or cytologic) of locally advanced cancer and / or metastatic disease;
  • presence of baseline pain of moderate intensity / severe, necessitating treatment with opioids of the 3rd step / WHO, already in progress or to be undertaken at a stage just prior to the start of the study (see also criterion 4 where indicates that "the pain of base must be adequately controlled with opioids of the wHO 3rd step");
  • estimated life expectancy of more than one month;
  • presence of BTCP, diagnosed according to the criteria set by the definition of BTCP and the algorithm of Davies, for which it is established to undertake a treatment "rescue" of painful episodes, with the appropriate opioid drugs at the time of commencement of the study;
  • capable of taking opioid medications for pain basic and breakthrough pain, by any route of administration;
  • aged more than 18 years.

Exclusion Criteria:

  • participation in other research projects that are in conflict or could confound the results of the study;
  • absence of informed consent, or withdrawal of consent for study participation;
  • presence of some pathological mental or psychiatric conditions, due to the tumor or concomitant diseases, which interfere with the state of consciousness or the ability to judge the point of jeopardizing the study protocol;
  • need treatment for comorbid conditions present at the beginning of the study that could create potentially dangerous drug interactions with opioids (conazolici use of antifungals or macrolide antibiotics);
  • contraindications of any kind for use of opioid drugs;
  • positivity of a story, past or current, of substance abuse;
  • inability to ensure regular follow-up;
  • diagnosis of primary tumor of the brain;
  • situation of the presence of BTCP already in treatment with opioid rescue of 3rd step;
  • decision to use drugs "rescue" of different opioid 3rd step / WHO (NSAIDs, opioids of 2 ° step), for the treatment of BTCP;
  • diagnosis of chronic renal failure proclaimed already in place, with values of blood creatinine ≥ 2 mg / dL.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01946555
Other Study ID Numbers Studio RER
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mario Negri Institute for Pharmacological Research
Study Sponsor Mario Negri Institute for Pharmacological Research
Collaborators Not Provided
Investigators
Principal Investigator: Oscar Corli, MD Mario Negri Institute of Pharmacological Research - IRCCS
PRS Account Mario Negri Institute for Pharmacological Research
Verification Date April 2016