Cancer RectumNCT06392399
Interventions for the Management of Perineal Cancer Pain
A study testing cooled radiofrequency ,, conventional radiofrequency and neurolysis of ganglion in people with Cancer Rectum and Cancer Vulva, run by Assiut University.
Trial summary
Pain associated with neoplasms may be of somatic, visceral, or neuropathic origin.Visceral pain or pain that is mediated by the sympathetic fibers in the perineal area associated with malignancy in the pelvis may be effectively treated with neurolysis of impar ganglion.In recent years, radiofrequency lesioning of the… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cancer Rectum, Cancer Vulva, Cancer Vagina
- What is being tested?
- cooled radiofrequency ,, conventional radiofrequency and neurolysis of ganglion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients aged from 20-70 years old, with lower third cancer rectum, caner vulva, cancer vagina and cancer perineum.
- The intensity of perineal pain on VAS score ≥ 5.
- Unsatisfactory treatment with tramadol (400 mg daily) , Pregabalin (150 mg daily) or presence of side effects of tramadol as headache, dizziness, constipation, rash, sweating, dry mouth.
- Included participants should show adequate response to diagnostic ganglion impar block , i.e. reduction of VAS pain score > 50% at least for 2 hours.
Who cannot join
- Infection of the skin at or near site of needle puncture.
- Coagulopathy or prolonged bleeding time.
- Drug hypersensitivity or allergy to the studied drugs.
- Central or peripheral neuropathy .
- Significant organ dysfunction as respiratory , liver or renal failure.
- Any psychiatric illness that would interfere with the perception and the assessment of pain.
- Vertebral anomalies.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cooled Radiofrequency in Comparison to Either Conventional Radiofrequency Thermocoagulation or Neurolytic Block of Ganglion Impar in the Management of Perineal Cancer Pain
Pain associated with neoplasms may be of somatic, visceral, or neuropathic origin.Visceral pain or pain that is mediated by the sympathetic fibers in the perineal area associated with malignancy in the pelvis may be effectively treated with neurolysis of impar ganglion.In recent years, radiofrequency lesioning of the ganglion Impar has evolved as a novel non pharmacological technique for the management of patients suffering from intractable perineal pain.
- Conditions
- Cancer Rectum, Cancer Vulva, Cancer Vagina
- Being tested
- cooled radiofrequency ,, conventional radiofrequency, neurolysis of ganglion
- Keywords
- cooled radiofrequency , conventional radiofrequency
- Medical subject headings
- Rectal Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooled radiofrequency ,Device
In Cooled RF, after placement of the introducer needle, the 18 gauge internally cooled RF electrode is used for 90 seconds at a temperature of 60°C.
conventional radiofrequencyDevice
In conventional RF group lesion will be performed at 80°C for 120 seconds.
neurolysis of ganglionDevice
In neurolytic block, Once the position of the needle tip confirmed, 4 - 6 mL of 8% phenol in saline will be injected followed by 1 mL of saline to avoid the deposition of phenol within the intervertebral disc material.
| Study group | Role | What they receive |
|---|---|---|
| Conventional radiofrequency | Active comparator | In this group we will use conventional radiofrequency thermocoagulation in the management of perineal cancer pain Receives: Device: conventional radiofrequency |
| Cooled radiofrequency | Active comparator | In this group we will use cooled radiofrequency in the management of perineal cancer pain Receives: Device: cooled radiofrequency , |
| Neurolytic block of Ganglion | Active comparator | In this group we will use neurolysis of ganglion impar in the management of perineal cancer pain Receives: Device: neurolysis of ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.
Patients rate pain on a scale from 0-10, 0 being no pain and 10 being the worst pain imaginable.
Measured: 2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.
Secondary outcomes (1)
Total Tramadol consumption
we will measure consumption of tramadol either it increasing or decreasing .
Measured: at 2 weeks, 1 month, 2 months and 3 months' post procedural.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer RectumStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abo eldahab Ali elden, Assiut University
- Investigators
- aya ali, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392399
- Sponsor's protocol ID
- 18-2024-679
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooled Radiofrequency in Comparison to Either Conventional Radiofrequency Thermocoagulation or Neurolytic Block of Ganglion Impar in the Management of Perineal Cancer Pain
- ClinicalTrials.gov ID
- NCT06392399
- Acronym / sponsor ID
- 18-2024-679
- Conditions
- Cancer Rectum, Cancer Vulva, Cancer Vagina
- Keywords
- cooled radiofrequency , conventional radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 Apr 2024 (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.
Pain associated with neoplasms may be of somatic, visceral, or neuropathic origin.Visceral pain or pain that is mediated by the sympathetic fibers in the perineal area associated with malignancy in the pelvis may be effectively treated with neurolysis of impar ganglion.In recent years, radiofrequency lesioning of the ganglion Impar has evolved as a novel non pharmacological technique for the management of patients suffering from intractable perineal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional radiofrequency | Active comparator | Device: conventional radiofrequencyIn this group we will use conventional radiofrequency thermocoagulation in the management of perineal cancer pain |
| Cooled radiofrequency | Active comparator | Device: cooled radiofrequency ,In this group we will use cooled radiofrequency in the management of perineal cancer pain |
| Neurolytic block of Ganglion | Active comparator | Device: neurolysis of ganglionIn this group we will use neurolysis of ganglion impar in the management of perineal cancer pain |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients aged from 20-70 years old, with lower third cancer rectum, caner vulva, cancer vagina and cancer perineum.
- The intensity of perineal pain on VAS score ≥ 5.
- Unsatisfactory treatment with tramadol (400 mg daily) , Pregabalin (150 mg daily) or presence of side effects of tramadol as headache, dizziness, constipation, rash, sweating, dry mouth.
- Included participants should show adequate response to diagnostic ganglion impar block , i.e. reduction of VAS pain score > 50% at least for 2 hours.
Key exclusion criteria (8 listed)
- Infection of the skin at or near site of needle puncture.
- Coagulopathy or prolonged bleeding time.
- Drug hypersensitivity or allergy to the studied drugs.
- Central or peripheral neuropathy .
- Significant organ dysfunction as respiratory , liver or renal failure.
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 |
|---|---|---|
| cooled radiofrequency ,In Cooled RF, after placement of the introducer needle, the 18 gauge internally cooled RF electrode is used for 90 seconds at a temperature of 60°C. | Device | Cooled radiofrequency |
| conventional radiofrequencyIn conventional RF group lesion will be performed at 80°C for 120 seconds. | Device | Conventional radiofrequency |
| neurolysis of ganglionIn neurolytic block, Once the position of the needle tip confirmed, 4 - 6 mL of 8% phenol in saline will be injected followed by 1 mL of saline to avoid the deposition of phenol within the intervertebral disc material. | Device | Neurolytic block of Ganglion |
Primary outcome
Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.
Time frame: 2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.
Patients rate pain on a scale from 0-10, 0 being no pain and 10 being the worst pain imaginable.
1 secondary outcome
Total Tramadol consumption
Time frame: at 2 weeks, 1 month, 2 months and 3 months' post procedural.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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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.
aya ali principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing cooled radiofrequency ,, conventional radiofrequency and neurolysis of ganglion in people with Cancer Rectum and Cancer Vulva, run by Assiut University.
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 4 inclusion and 8 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 2 May 2024. 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 aya ali (01068744428, totaaboeldahab8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value. (time frame: 2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.). 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 2 May 2024.