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
About this trial
This is an interventional supportive care trial for Cancer Pain
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
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
NCT ID
NCT05594459
First Posted
October 19, 2022
Last Updated
October 25, 2022
Sponsor
Regina Elena Cancer Institute
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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