NCT05594459

Early Treatment With Invasive Technique in Cancer Pain Management

Status unknown NA Last updated 26 October 2022

What this trial tests

NA trial testing Mini invasive analgesic technique in Cancer Pain in 76 participants. Status unknown.

Timeline

25 November 2022

Primary endpoint
25 July 2024

30 December 2024

Quick facts

Lead sponsor	Regina Elena Cancer Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	76
Start date	25 November 2022
Primary completion	25 July 2024
Estimated completion	30 December 2024

Drugs / interventions tested

• Mini invasive analgesic technique
• high opioids dosages — full drug profile →

Conditions studied

• Cancer Pain — all drugs for Cancer Pain →
• Opioid Use — all drugs for Opioid Use →

Sponsor

Regina Elena Cancer Institute

Who can join

Adults 18 to 75, any sex, with Cancer Pain or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sympathetic nerve blocks for persistent pain in adults with inoperable abdominopelvic cancer.
   Nagar SD, Nagar SJ, Jordan V, Dawson J. · · 2024 · cited 2× · PMID 38842054 · DOI 10.1002/14651858.cd015229.pub2