Early Treatment With Invasive Technique in Cancer Pain Management

Sponsor

Regina Elena Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05594459

Collaborator

(none)

Enrollment

Arms

25.2

Anticipated Duration (Months)

Study Details

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%.

Condition or Disease	Intervention/Treatment	Phase
Cancer Pain Opioid Use	Procedure: Mini invasive analgesic technique Drug: high opioids dosages	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Early Treatment With Invasive Technique in Cancer Pain Management, Impact on Patient's Quality of Life. A Randomized Clinical Trial

Anticipated Study Start Date :

Nov 25, 2022

Anticipated Primary Completion Date :

Jul 25, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Opioids	Drug: high opioids dosages patients will be treated with high opioids dosages
Experimental: Mini invasive	Procedure: Mini invasive analgesic technique patients will be treated with early interventional neuromodulatory techniques, before high opioids dosages.

Arm

Intervention/Treatment

Active Comparator: Opioids

Drug: high opioids dosages

patients will be treated with high opioids dosages

Experimental: Mini invasive

Procedure: Mini invasive analgesic technique

patients will be treated with early interventional neuromodulatory techniques, before high opioids dosages.

Outcome Measures

Primary Outcome Measures

Change in European Organization for Research and Treatment of Cancer Quality of life-Core 30 Summary Score (EORTC-QLQ C30) [V0 (up to 2 weeks), V1 (One month after), V2 (3 months later)]
difference of the quality of life questionnaire score between the groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Regina Elena Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ester Forastiere, MD, Director of Anesthesiology and Intensive Care Utin, Regina Elena Cancer Institute

ClinicalTrials.gov Identifier:

NCT05594459

Other Study ID Numbers:

V1.18.10.22

First Posted:

Oct 26, 2022

Last Update Posted:

Oct 26, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cancer Pain

Analgesics

Study Results

No Results Posted as of Oct 26, 2022