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Early Treatment With Invasive Technique in Cancer Pain Management

Primary Purpose

Cancer Pain, Opioid Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mini invasive analgesic technique
high opioids dosages
Sponsored by
Regina Elena Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of an oncological disease defined as not curable
  • Pain localized in the abdomen, described as severe with NRS ≥ 7
  • American Society of Anesthesiology status ≤ III
  • Karnofsky performance status scale ≥60%
  • Written informed consent

Exclusion Criteria:

  • Inability to answer / fill in questionnaires
  • Patients under psychotherapy treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Opioids

    Mini invasive

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in European Organization for Research and Treatment of Cancer Quality of life-Core 30 Summary Score (EORTC-QLQ C30)
    difference of the quality of life questionnaire score between the groups

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2022
    Last Updated
    October 25, 2022
    Sponsor
    Regina Elena Cancer Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05594459
    Brief Title
    Early Treatment With Invasive Technique in Cancer Pain Management
    Official Title
    Early Treatment With Invasive Technique in Cancer Pain Management, Impact on Patient's Quality of Life. A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 25, 2022 (Anticipated)
    Primary Completion Date
    July 25, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Regina Elena Cancer Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Background: high or moderate intensity pain hits more than a half of patients with cancer and is not adequately treated way in 1/3 of this patients. Complexity of cancer pain makes right management difficult and the consequences of an incorrect management are far-reaching in a clinical and social way. A multimodal treatment tailored on the patient, and the evaluation of quality of life correlated to different treatment methodologies, must constitute a decisive element in terms of therapeutic choices. Over the past 30 years, the World Health Organization (WHO) analgesic step ladder has been used to guide the choices management of cancer-related pain, but in the last years the growth of innovative treatment strategies, led to the need to modulate this rigid yet useful system. Benefits would be obtained with interventional techniques (peripheral neural blockade, neuromodulatory device use, neuro-destructive techniques, and intrathecal drug delivery systems) performed in the initial parts of the treatment cycle (before the third step of the WHO scale), rather than applied according to the WHO scale algorithm. Some authors who adopted this approach, reported reduction in pain duration and less opioid consumption, minimizing the risk of opioid related side effects and an improving the overall quality of life . The hypothesis is that early application of interventional techniques in oncological patients has an improving effect in the treatment of chronic cancer pain in terms of efficacy and quality of life. Materials and methods: patients followed by the Cancer Pain Therapy Service of the Cancer National Institute Regina Elena, Rome, with chronic localizable abdominal pain with a value ≥ 7 according to the numeric rating scale (NRS) and a diagnosis of untreatable disease will be randomized into two groups: in the first group patients will be treated with early interventional neuromodulatory techniques, before high opioids dosages. The other group will follow the steps of the WHO scale. Every patient will receive the European Organization for Research and Treatment of Cancer Quality of life-Core 30 Summary Score (EORTC-QLQ C30) survey to detect quality of life and the Numeric rate scale NRS. They will receive it before the treatment, after invasive procedure, one month later and six months later. Primary end point will be the difference of the quality of life questionnaire score between the groups; secondary end point will be difference in the NRS values. The statistic analysis will be based on two groups of patients responding to the including criteria. The sample will be made of 76 patients divided in two sub-sample of equal dimension to select and analyze in 18 months. The sample thus defined is consistent for a confidence interval of 80% and for a margin of error of less than 5%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Pain, Opioid Use

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Opioids
    Arm Type
    Active Comparator
    Arm Title
    Mini invasive
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Mini invasive analgesic technique
    Intervention Description
    patients will be treated with early interventional neuromodulatory techniques, before high opioids dosages.
    Intervention Type
    Drug
    Intervention Name(s)
    high opioids dosages
    Intervention Description
    patients will be treated with high opioids dosages
    Primary Outcome Measure Information:
    Title
    Change in European Organization for Research and Treatment of Cancer Quality of life-Core 30 Summary Score (EORTC-QLQ C30)
    Description
    difference of the quality of life questionnaire score between the groups
    Time Frame
    V0 (up to 2 weeks), V1 (One month after), V2 (3 months later)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of an oncological disease defined as not curable Pain localized in the abdomen, described as severe with NRS ≥ 7 American Society of Anesthesiology status ≤ III Karnofsky performance status scale ≥60% Written informed consent Exclusion Criteria: Inability to answer / fill in questionnaires Patients under psychotherapy treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ester Forastiere, MD
    Phone
    00390652665024
    Email
    ester.forastiere@ifo.it

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Early Treatment With Invasive Technique in Cancer Pain Management

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