Chemotherapy-induced Peripheral NeuropathyPhase 2NCT05348408
Efficacy of Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy
A Phase 2 study testing platelet rich plasma in people with Chemotherapy-induced Peripheral Neuropathy, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
This study aims to show the efficacy and safety of ultra-sound guided peri-neural platelet rich injection in treatment of chemotherapy induced peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Dec 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cancer patients with peripheral neuropathy confirmed by clinical evaluation and nerve conduction study despite of medical treatment
Who cannot join
- Foot ulcers and / or amputation.
- Peripheral vascular disease.
- Uncontrolled diabetes
- Vertebral pathologies.
- Connective tissue diseases.
- Thyriod disorders, significant renal or hepatic dysfunction.
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- Platelet dysfunction syndrome, critical thrombocytopenia.
- Septicemia and local infection at the site of the procedure.
- Systemic corticosteriod adminstiration or local injection at the suspected treatment site within the last month.
- Recent fever or illness.
- Hemoglobin level less than 10 g/dl, platelet count less than 105-109/L.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pain clinic and intervention unit at South Egypt Cancer Institute, Assuit University
Asyut, Egypt, 71514
About this study
Official title: Efficacy of Ultra-sound Guided Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy: Randomized Controlled Trial
This study aims to show the efficacy and safety of ultra-sound guided peri-neural platelet rich injection in treatment of chemotherapy induced peripheral neuropathy.
Read the detailed description
This study is prospective, randomized, assessor blinded controlled trial. It is aims to study the effect of perineural platelet rich plasma injection in cancer patients with prepheral neuropathy despite of stoppage chemotherapy for 6 months and usage of medical treatment.
Ultrasound-guided PRP injection will be performed after preparation of plasma obtained from the patient by using 10-19 MHz high frequency linear transducer to scan the superficial nerves.
- Being tested
- platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaDrug
Also called medical treatment
perineural PRP injection under ultrasound guidance in addition to medical treatment
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma | Active comparator | patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve Receives: Drug: platelet rich plasma |
| contact group | Sham comparator | only medical treatment in form of opioid and NSAIDs will be used Receives: Drug: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of pain after injection
Change in severity of pain after prp injection wii be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 =worst imaginable pain
Measured: baseline, 15 days, 1 month, 2 months, 3 months
Secondary outcomes (4)
total neuropathy score
Peripheral neuropathy severity assessed using the reduced version of the Total Neuropathy Score (TNSr) due to feasibility and resource limitations
Measured: baseline, 15 days, 1 month, 2 months, 3 months
The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx)
a 27 questionnaire that measure health related quality of life in patients with cancer ad chronic illnesses
Measured: baseline, 15 days, 1 month, 2 months, 3 months
Nerve conduction study
To measure how fast the electrical impulses moves through the nerve.
Measured: baseline, 3 months
A 7- point Likert like verbal rating scale
extremely dissatisfied = 1, dissatisfied = 2, somewhat dissatisfied = 3, undecided = 4, somewhat satisfied = 5, satisfied = 6 and extremely satisfied = 7
Measured: baseline, 15 days, 1 month, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayira Mahmoud El-Husseini, South Egypt Cancer Institute
- Investigators
- Nayira Mahmoud Elhusseini, MSc, Principal investigator, South Egypt Cancer Institute, Assuit university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348408
- Sponsor's protocol ID
- 573
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultra-sound Guided Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05348408
- Acronym / sponsor ID
- 573
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Apr 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.
This study aims to show the efficacy and safety of ultra-sound guided peri-neural platelet rich injection in treatment of chemotherapy induced peripheral neuropathy.
Detailed description
This study is prospective, randomized, assessor blinded controlled trial. It is aims to study the effect of perineural platelet rich plasma injection in cancer patients with prepheral neuropathy despite of stoppage chemotherapy for 6 months and usage of medical treatment.
Ultrasound-guided PRP injection will be performed after preparation of plasma obtained from the patient by using 10-19 MHz high frequency linear transducer to scan the superficial nerves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma | Active comparator | Drug: platelet rich plasmapatients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve |
| contact group | Sham comparator | Drug: platelet rich plasmaonly medical treatment in form of opioid and NSAIDs will be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cancer patients with peripheral neuropathy confirmed by clinical evaluation and nerve conduction study despite of medical treatment
Key exclusion criteria (11 listed)
- Foot ulcers and / or amputation.
- Peripheral vascular disease.
- Uncontrolled diabetes
- Vertebral pathologies.
- Connective tissue diseases.
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 |
|---|---|---|
| platelet rich plasmaAlso: medical treatmentperineural PRP injection under ultrasound guidance in addition to medical treatment | Drug | contact group, platelet rich plasma |
Primary outcome
Change in severity of pain after injection
Time frame: baseline, 15 days, 1 month, 2 months, 3 months
Change in severity of pain after prp injection wii be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 =worst imaginable pain
4 secondary outcomes
total neuropathy score
Time frame: baseline, 15 days, 1 month, 2 months, 3 months
The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx)
Time frame: baseline, 15 days, 1 month, 2 months, 3 months
Nerve conduction study
Time frame: baseline, 3 months
A 7- point Likert like verbal rating scale
Time frame: baseline, 15 days, 1 month, 2 months, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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.
Nayira Mahmoud Elhusseini, MSc principal investigator
South Egypt Cancer Institute, Assuit university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing platelet rich plasma in people with Chemotherapy-induced Peripheral Neuropathy, run by South Egypt Cancer Institute 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 24 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of pain after injection (time frame: baseline, 15 days, 1 month, 2 months, 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 24 Apr 2026.