Clinical trial NCT05111730: Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients
Official title: Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients:A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: PERIPHERAL NEUROPATHY
CHEMOTHERAPY
SHOCKWAVE
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient with osteoporosis.
* Patient with DVT.
* Patient have a Pacemaker fitted
* Uncooperative patients

Primary outcomes:
measure: Malondialdehyde (MDA) as oxidative stress marker
timeFrame: Malondialdehyde (MDA) level was assessed at day 0.
measure: Malondialdehyde (MDA) as oxidative stress marker
timeFrame: Malondialdehyde (MDA) level will be assessed at day 90.
measure: Interlukin 6 (IL-6) as inflammatory marker
timeFrame: Interlukin 6 (IL-6) level was assessed at day 0.
measure: Interlukin 6 (IL-6) as inflammatory marker
timeFrame: Interlukin 6 (IL-6) level will be assessed at day 90.
measure: Plasma Neurotensin (NT) as potential marker for neuropathic pain
timeFrame: Plasma Neurotensin (NT)level was assessed at day 0.
measure: Plasma Neurotensin (NT) as potential marker for neuropathic pain
timeFrame: Plasma Neurotensin (NT)level will be assessed at day 90.
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
state: Qina
Study officials:
affiliation: South Valley University
name: Mohammed E Ali, Ph.D student
role: PRINCIPAL_INVESTIGATOR
References: