Clinical trial NCT06725043: Ultrasound Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
Official title: Ultrasound Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Patients and Their Partners
Oxaliplatin-induced Peripheral Neuropathy
Keywords: oxaliplatin
peripheral neuropathy
ultrasound acupuncture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The current study was conducted to examine the effect of ultrasound acupuncture for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.

Detailed description: Oxaliplatin is platinum-based chemotherapy most usually used for the treatment of metastatic colorectal cancer, this drug can produce a cumulative and dose-limiting distal sensory neuropathy affecting the majority of oxaliplatin-treated patients. Despite intense investigation at the preclinical and clinical levels, no treatment can be suggested for the prevention of OIPN. Since acupuncture has proven effective in alleviating the severity of peripheral nerve neuropathy, as has ultrasound.

This systematic review was conducted to test the ability of ultrasound acupuncture in decreasing neuropathy-related symptoms induced by oxaliplatin-based chemotherapies in colorectal cancer patients

Eligibility criteria: Inclusion Criteria:

-

The subject selection was according to the following criteria:

* Adults their ages ranged from 20 to 70 years old.
* Receiving or have received chemotherapy treatment for colon or rectal cancer.
* Chemotherapy regimen included the agent oxaliplatin.
* Patients diagnosed with neuropathy by the oncologist.
* Both sexes.
* No neuropathy prior to oxaliplatin treatment.
* No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis)
* Stage II, III and IV colon or rectal cancer.
* Hands and Feets were the most affected by CIPN.
* The first dose of oxaliplatin was from 4 months or more.

Exclusion Criteria:

* The potential participants were excluded in the following conditions:

  * Another malignancy
  * Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
  * Participants who cannot remain on the same medications throughout the study period with minor dose adjustments allowed.
  * Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet (representing severe CIPN), metal or plastic implantation
  * Peripheral vascular disease in hands or feet.

Primary outcomes:
measure: Pain level assessment
timeFrame: 2.5 months
measure: Assessment of pain pressure threshold
timeFrame: 2.5 months
Secondary outcomes:
measure: National Cancer Institute Common Toxicity Criteria
timeFrame: 2.5 months
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of Physical Therapy, Suez Canal University
state: Ismalia
Study officials:
References: