Peripheral NeuropathyNCT05111730
Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients
A study testing The Shock wave Therapy. in people with Peripheral Neuropathy, run by South Valley University at 1 site in Egypt.
Trial summary
This study aimed to assess the efficacy of shock wave in reducing Chemotherapy- Induced Peripheral Neuropathy in adult and pediatric tumors patients. Read more about this study
- Who is it for?
- Ages 8 to 40 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- The Shock wave Therapy.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 May 2022
- 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 8 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Their age will ranging from eight to forty years.
- All cases participated in this study will from both sexes.
- All cases receiving chemotherapy as primary treatment, postoperative surgical removal of tumors or with conjunction with radiotherapy
- All cases have polyneuropathy caused by chemotherapy.
Who cannot join
- Patient with osteoporosis.
- Patient with DVT.
- Patient have a Pacemaker fitted
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Valley University, Faculty of Physical Therapy
Qina, Qena Governorate, 83523
Mohammed E. Ali., Ph.D student, 01011212425, m.essam@svu.edu.eg
Nehad A. Abo-zaid, Ph.D, +201223265216, dr.nehadahmed@svu.edu.eg
About this study
Official title: Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients:A Randomized Controlled Trail
This study aimed to assess the efficacy of shock wave in reducing Chemotherapy- Induced Peripheral Neuropathy in adult and pediatric tumors patients.
Read the detailed description
Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and nonpharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.
- Conditions
- Peripheral Neuropathy
- Being tested
- The Shock wave Therapy.
- Keywords
- PERIPHERAL NEUROPATHY, CHEMOTHERAPY, SHOCKWAVE
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Shock wave Therapy.Device
Shockwave therapy is a multidisciplinary device used in orthopedics, physiotherapy, sports medicine, urology and veterinary medicine. Its main assets are fast pain relief and mobility restoration. Together with being a non-surgical therapy with no need for painkillers makes it an ideal therapy to speed up recovery and cure various indications causing acute or chronic pain. Shockwave is an acoustic wave which carries high energy to painful spots and myoskeletal tissues with sub-acute, sub-chronic and chronic conditions. The energy promotes regeneration and reparative processes of the bones, tendons and other soft tissues. Shockwaves are characterized by jump change in pressure, high amplitude and non-periodicity. The kinetic energy of the projectile, created by compressed air, is transferred to the transmitter at the end of the applicator and further into the tissue.
| Study group | Role | What they receive |
|---|---|---|
| The shockwave Group | Experimental | Group (A) study group received medical care and standard chemotherapy and shock wave, three times / week for three successful months. Receives: Device: The Shock wave Therapy. |
| the traditional treatment group | No intervention | group (B) control group received medical care and standard chemotherapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde (MDA) as oxidative stress marker
Malondialdehyde level in blood will be measured
Measured: Malondialdehyde (MDA) level was assessed at day 0.
Malondialdehyde (MDA) as oxidative stress marker
Malondialdehyde level in blood will be measured
Measured: Malondialdehyde (MDA) level will be assessed at day 90.
Interlukin 6 (IL-6) as inflammatory marker
Interlukin 6 (IL-6) level in blood will be measured
Measured: Interlukin 6 (IL-6) level was assessed at day 0.
Interlukin 6 (IL-6) as inflammatory marker
Interlukin 6 (IL-6) level in blood will be measured
Measured: Interlukin 6 (IL-6) level will be assessed at day 90.
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Plasma Neurotensin (NT) level in blood will be measured
Measured: Plasma Neurotensin (NT)level was assessed at day 0.
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Plasma Neurotensin (NT) level in blood will be measured
Measured: Plasma Neurotensin (NT)level will be assessed at day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eighty children with tumors were enrolled in this study and were assessed for eligibility. Their aged ranged from eight and forty years. They were assigned randomly into two equal groups. Group (A) study group received the same medical care and shock wave, three times / weak for three successful months. And group (B) control group received medical care and standard chemotherapy only.Nerve conduction studies (NCS) and somatosensory-evoked potentials (SSEPs) were used to assess peripheral neuropathy pre and post intervention. All children were assisted before and after three months of intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed E. Ali, Ph. D Candidate., South Valley University
- Investigators
- Mohammed E Ali, Ph.D student, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111730
- Sponsor's protocol ID
- P.T.REC/012/002568
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients:A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05111730
- Acronym / sponsor ID
- P.T.REC/012/002568
- Conditions
- Peripheral Neuropathy
- Keywords
- PERIPHERAL NEUROPATHY, CHEMOTHERAPY, SHOCKWAVE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 8 Nov 2021 (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.
This study aimed to assess the efficacy of shock wave in reducing Chemotherapy- Induced Peripheral Neuropathy in adult and pediatric tumors patients.
Detailed description
Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and nonpharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eighty children with tumors were enrolled in this study and were assessed for eligibility. Their aged ranged from eight and forty years. They were assigned randomly into two equal groups. Group (A) study group received the same medical care and shock wave, three times / weak for three successful months. And group (B) control group received medical care and standard chemotherapy only.Nerve conduction studies (NCS) and somatosensory-evoked potentials (SSEPs) were used to assess peripheral neuropathy pre and post intervention. All children were assisted before and after three months of intervention.
| Arm | Type | Receives |
|---|---|---|
| The shockwave Group | Experimental | Device: The Shock wave Therapy.Group (A) study group received medical care and standard chemotherapy and shock wave, three times / week for three successful months. |
| the traditional treatment group | No intervention | –group (B) control group received medical care and standard chemotherapy only. |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Their age will ranging from eight to forty years.
- All cases participated in this study will from both sexes.
- All cases receiving chemotherapy as primary treatment, postoperative surgical removal of tumors or with conjunction with radiotherapy
- All cases have polyneuropathy caused by chemotherapy.
Key exclusion criteria (4 listed)
- Patient with osteoporosis.
- Patient with DVT.
- Patient have a Pacemaker fitted
- Uncooperative patients
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 |
|---|---|---|
| The Shock wave Therapy.Shockwave therapy is a multidisciplinary device used in orthopedics, physiotherapy, sports medicine, urology and veterinary medicine. Its main assets are fast pain relief and mobility restoration. Together with being a non-surgical therapy with no need for painkillers makes it an ideal therapy to speed up recovery and cure various indications causing acute or chronic pain. Shockwave is an acoustic wave which carries high energy to painful spots and myoskeletal tissues with sub-acute, sub-chronic and chronic conditions. The energy promotes regeneration and reparative processes of the bones, tendons and other soft tissues. Shockwaves are characterized by jump change in pressure, high amplitude and non-periodicity. The kinetic energy of the projectile, created by compressed air, is transferred to the transmitter at the end of the applicator and further into the tissue. | Device | The shockwave Group |
Primary outcome
Malondialdehyde (MDA) as oxidative stress marker
Time frame: Malondialdehyde (MDA) level was assessed at day 0.
Malondialdehyde level in blood will be measured
Malondialdehyde (MDA) as oxidative stress marker
Time frame: Malondialdehyde (MDA) level will be assessed at day 90.
Malondialdehyde level in blood will be measured
Interlukin 6 (IL-6) as inflammatory marker
Time frame: Interlukin 6 (IL-6) level was assessed at day 0.
Interlukin 6 (IL-6) level in blood will be measured
Interlukin 6 (IL-6) as inflammatory marker
Time frame: Interlukin 6 (IL-6) level will be assessed at day 90.
Interlukin 6 (IL-6) level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Time frame: Plasma Neurotensin (NT)level was assessed at day 0.
Plasma Neurotensin (NT) level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Time frame: Plasma Neurotensin (NT)level will be assessed at day 90.
Plasma Neurotensin (NT) level in blood will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- 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.
Mohammed E Ali, Ph.D student principal investigator
South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Shock wave Therapy. in people with Peripheral Neuropathy, run by South Valley University at 1 site in Egypt.
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 4 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 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mohammed E Ali, Ph.D student (01011212425, m.essam@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malondialdehyde (MDA) as oxidative stress marker (time frame: Malondialdehyde (MDA) level was assessed at day 0.). The study lists 6 primary outcomes in all. 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 8 Nov 2021.