Ultrasound Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients

Cairo University (CU)

Status: Completed

Conditions: Oxaliplatin-induced Peripheral Neuropathy; Colorectal Cancer Patients and Their Partners

Treatments: Device: Placebo therapeutic ultrasound; Other: Traditional physical therapy program; Device: Therapeutic ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06725043

Ultrasound Acupuncture for OIP

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Therapeutic ultrasound (1 MHz) Pulsed mode at bilateral acupuncture points of PC6, PC7, BL60 andKI1

Treatment:

Device: Therapeutic ultrasound

Other: Traditional physical therapy program

Experime

Placebo Comparator group

Description:

Placebo Therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI1

Treatment:

Other: Traditional physical therapy program

Device: Placebo therapeutic ultrasound