CancerNCT06543264
Efficacy of Cryotherapy in Managing Chemotherapy-Induced Peripheral Neuropathy in Children With Leukemia
A study testing Cryotherapy in people with Cancer, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Cancer
- What is being tested?
- Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Jan 2025
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age will ranging from eight to seventeen years.
- Children participated in this study will from both sexes.
- Children receiving chemotherapy as medical treatment protocol
- All children have polyneuropathy caused by chemotherapy.
Who cannot join
- Children with Epilepsy.
- Children with blood clotting disorder.
- Children have Open wounds / broken skin
- Children with severe cardiac disease
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley University, Faculty of Physical Therapy
Qina, 83523
Nehad A. Abo-zaid,, PHD, 01223265216, dr.nehadahmed@svu.edu.eg
About this study
This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children
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 non pharmacologic 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
- Cancer
- Being tested
- Cryotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Cryotherapy is a pain treatment that uses a method of localized freezing temperatures to deaden an irritated nerve. Cryotherapy is also used as a method of treating localized areas of some cancers (called cryosurgery), such as prostate cancer and to treat abnormal skin cells by dermatologists
| Study group | Role | What they receive |
|---|---|---|
| the study group | Experimental | Cryotherapy (apparatus) Receives: Device: Cryotherapy |
| the control group | No intervention | not received cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction studies (NCS)
nerve conduction velocity for sensory ulnar nerve
Measured: nerve conduction velocity for sensory ulnar nerve at day 0
Nerve conduction studies (NCS)
nerve conduction velocity for sensory ulnar nerve
Measured: nerve conduction velocity for sensory ulnar nerve at day 90
Nerve conduction studies (NCS)
nerve conduction velocity for sensory median nerve
Measured: nerve conduction velocity for sensory sensory median nerve at day 0
Nerve conduction studies (NCS)
nerve conduction velocity for sensory median nerve
Measured: nerve conduction velocity for sensory sensory median nerve 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 posted7 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa eldesoukey heneidy, Delta University for Science and Technology
- Investigators
- Nehad A. Abo-zaid, PHD, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543264
- Sponsor's protocol ID
- Cryotherapy and Leukemia
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 12 Aug 2024
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cryotherapy in Managing Chemotherapy-Induced Peripheral Neuropathy in Children With Leukemia
- ClinicalTrials.gov ID
- NCT06543264
- Acronym / sponsor ID
- Cryotherapy and Leukemia
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Aug 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.
This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children
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 non pharmacologic 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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the study group | Experimental | Device: CryotherapyCryotherapy (apparatus) |
| the control group | No intervention | –not received cryotherapy |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their age will ranging from eight to seventeen years.
- Children participated in this study will from both sexes.
- Children receiving chemotherapy as medical treatment protocol
- All children have polyneuropathy caused by chemotherapy.
Key exclusion criteria (5 listed)
- Children with Epilepsy.
- Children with blood clotting disorder.
- Children have Open wounds / broken skin
- Children with severe cardiac disease
- 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 |
|---|---|---|
| CryotherapyCryotherapy is a pain treatment that uses a method of localized freezing temperatures to deaden an irritated nerve. Cryotherapy is also used as a method of treating localized areas of some cancers (called cryosurgery), such as prostate cancer and to treat abnormal skin cells by dermatologists | Device | the study group |
Primary outcome
Nerve conduction studies (NCS)
Time frame: nerve conduction velocity for sensory ulnar nerve at day 0
nerve conduction velocity for sensory ulnar nerve
Nerve conduction studies (NCS)
Time frame: nerve conduction velocity for sensory ulnar nerve at day 90
nerve conduction velocity for sensory ulnar nerve
Nerve conduction studies (NCS)
Time frame: nerve conduction velocity for sensory sensory median nerve at day 0
nerve conduction velocity for sensory median nerve
Nerve conduction studies (NCS)
Time frame: nerve conduction velocity for sensory sensory median nerve at day 90
nerve conduction velocity for sensory median nerve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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.
Nehad A. Abo-zaid, PHD 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 Cryotherapy in people with Cancer, run by Delta University for Science and Technology 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 5 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 12 Aug 2024. 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 Walaa E Heneidy, PHD (+20127512697, walaa.eldesoukey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction studies (NCS) (time frame: nerve conduction velocity for sensory ulnar nerve at day 0). The study lists 4 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 12 Aug 2024.