Cancer PainNCT05594459
Early Treatment With Invasive Technique in Cancer Pain Management
A study testing Mini invasive analgesic technique and high opioids dosages in people with Cancer Pain and Opioid Use, run by Regina Elena Cancer Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Pain, Opioid Use
- What is being tested?
- Mini invasive analgesic technique and high opioids dosages
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to answer / fill in questionnaires
- Patients under psychotherapy treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Treatment With Invasive Technique in Cancer Pain Management, Impact on Patient's Quality of Life. A Randomized Clinical Trial
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 .
Read more
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%.
- Conditions
- Cancer Pain, Opioid Use
- Being tested
- Mini invasive analgesic technique, high opioids dosages
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini invasive analgesic techniqueProcedure or surgery
patients will be treated with early interventional neuromodulatory techniques, before high opioids dosages.
high opioids dosagesDrug
patients will be treated with high opioids dosages
| Study group | Role | What they receive |
|---|---|---|
| Opioids | Active comparator | Not described Receives: Drug: high opioids dosages |
| Mini invasive | Experimental | Not described Receives: Procedure: Mini invasive analgesic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: V0 (up to 2 weeks), V1 (One month after), V2 (3 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start25 Nov 2022 (estimated)
- Primary completion25 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, MD, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594459
- Sponsor's protocol ID
- V1.18.10.22
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment With Invasive Technique in Cancer Pain Management, Impact on Patient's Quality of Life. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05594459
- Acronym / sponsor ID
- V1.18.10.22
- Conditions
- Cancer Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 25 Nov 2022 (estimated)
- Primary completion
- 25 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioids | Active comparator | Drug: high opioids dosages |
| Mini invasive | Experimental | Procedure: Mini invasive analgesic technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to answer / fill in questionnaires
- Patients under psychotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini invasive analgesic techniquepatients will be treated with early interventional neuromodulatory techniques, before high opioids dosages. | Procedure or surgery | Mini invasive |
| high opioids dosagespatients will be treated with high opioids dosages | Drug | Opioids |
Primary outcome
Change in European Organization for Research and Treatment of Cancer Quality of life-Core 30 Summary Score (EORTC-QLQ C30)
Time frame: V0 (up to 2 weeks), V1 (One month after), V2 (3 months later)
difference of the quality of life questionnaire score between the groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Mini invasive analgesic technique and high opioids dosages in people with Cancer Pain and Opioid Use, run by Regina Elena Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ester Forastiere, MD (00390652665024, ester.forastiere@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in European Organization for Research and Treatment of Cancer Quality of life-Core 30 Summary Score (EORTC-QLQ C30) (time frame: V0 (up to 2 weeks), V1 (One month after), V2 (3 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.