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CancerNCT04536207

Cryotherapy for Neuropathy in Children

A study testing Cryotherapy (apparatus) in people with Cancer, run by South Valley University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 (apparatus)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Feb 2022to 15 Jul 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 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.

Nehad A. Abo-Zaid, Ph.D contact

+201223265216

dr.nehadahmed@svu.edu.eg

Mohammed E Ali, Ph.D student contact

+201011212425

m.essam@svu.edu.eg

Egypt1 site, 1 recruiting

  • South Valley University, Faculty of Physical Therapy

    Qina, 83523

    Nehad A Abo-zaid, Lecturer, 01223265216, dr.nehadahmed@svu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Cryotherapy in Controlling Peripheral Neuropathy in Cancer Children

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 (apparatus)
Keywords
Cancer, Peripheral neuropathy, Cryotherapy
Medical subject headings
Neoplasms, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cryotherapy (apparatus)Other

    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 groups in NCT04536207
Study groupRoleWhat they receive
the study groupExperimentalGroup (A) the study group received cryotherapy
Receives: Other: Cryotherapy (apparatus)
the control groupNo interventionGroup (B) the control group not received cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nerve conduction studies (NCS)

    nerve conduction velocity for sensory ulnar nerve

    Measured: nerve conduction velocity for sensory ulnar nerve at day 0

  2. Nerve conduction studies (NCS)

    nerve conduction velocity for sensory ulnar nerve

    Measured: nerve conduction velocity for sensory ulnar nerve at day 90

  3. Nerve conduction studies (NCS)

    nerve conduction velocity for sensory median nerve

    Measured: nerve conduction velocity for sensory sensory median nerve at day 0

  4. Nerve conduction studies (NCS)

    nerve conduction velocity for sensory median nerve

    Measured: nerve conduction velocity for sensory sensory median nerve at day 90

  5. Nerve conduction studies (NCS)

    nerve conduction velocity for sensory sural nerve

    Measured: nerve conduction velocity for sensory sural nerve at day 0

  6. Nerve conduction studies (NCS)

    nerve conduction velocity for sensory sural nerve

    Measured: nerve conduction velocity for sensory sural nerve at day 90

  7. Nerve conduction studies (NCS)

    nerve conduction velocity for motor common peroneal nerve

    Measured: nerve conduction velocity for motor common peroneal nerve at day 0

  8. Nerve conduction studies (NCS)

    nerve conduction velocity for motor common peroneal nerve

    Measured: nerve conduction velocity for motor common peroneal 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.

  1. First posted2 Sep 2020
  2. Study start1 Feb 2022 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion15 Jul 2022 (estimated)

Resources

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
They were assigned randomly into two equal groups.Group (A) study group received the same medical care and cryotherapy, three times / weak for three successful months. And group (B) control group received medical care and standard chemotherapy only.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536207
Sponsor's protocol ID
P.T.REC/012/002570
Status last verified
Oct 2021
First submitted
16 Aug 2020
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

    PubMed 25261162

  • Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.

    PubMed 24733808

  • Scotte F, Banu E, Medioni J, Levy E, Ebenezer C, Marsan S, Banu A, Tourani JM, Andrieu JM, Oudard S. Matched case-control phase 2 study to evaluate the use of a frozen sock to prevent docetaxel-induced onycholysis and cutaneous toxicity of the foot. Cancer. 2008 Apr 1;112(7):1625-31. doi: 10.1002/cncr.23333.

    PubMed 18286527

  • Hanai A, Ishiguro H, Sozu T, Tsuda M, Yano I, Nakagawa T, Imai S, Hamabe Y, Toi M, Arai H, Tsuboyama T. Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. J Natl Cancer Inst. 2018 Feb 1;110(2):141-148. doi: 10.1093/jnci/djx178.

    PubMed 29924336

  • Tsuyuki S, Senda N, Kanng Y, Yamaguchi A, Yoshibayashi H, Kikawa Y, Katakami N, Kato H, Hashimoto T, Okuno T, Yamauchi A, Inamoto T. Evaluation of the effect of compression therapy using surgical gloves on nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: a phase II multicenter study by the Kamigata Breast Cancer Study Group. Breast Cancer Res Treat. 2016 Nov;160(1):61-67. doi: 10.1007/s10549-016-3977-7. Epub 2016 Sep 12.

    PubMed 27620884

  • Kadakia KC, Rozell SA, Butala AA, Loprinzi CL. Supportive cryotherapy: a review from head to toe. J Pain Symptom Manage. 2014 Jun;47(6):1100-15. doi: 10.1016/j.jpainsymman.2013.07.014. Epub 2013 Nov 7.

    PubMed 24210702

Questions about this trial

What is this clinical trial studying?

A study testing Cryotherapy (apparatus) in people with Cancer, 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 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 15 Oct 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 Nehad A. Abo-Zaid, Ph.D (+201223265216, dr.nehadahmed@svu.edu.eg), 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 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536207, which also lists 6 linked publications.

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 15 Oct 2021.

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Cryotherapy for Neuropathy in Children (NCT04536207) | AzTrials