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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06725043
Enrollment
60
Registered
2024-12-10
Start date
2023-07-01
Completion date
2024-12-03
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Patients and Their Partners, Oxaliplatin-induced Peripheral Neuropathy

Keywords

oxaliplatin, peripheral neuropathy, ultrasound acupuncture

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

Interventions

DEVICETherapeutic ultrasound

Pulsed therapeutic ultrasound (1 MHz , 50% duty cycle and intensity gradually increased till the patient felt a deqi sensation).Each point was stimulated by ultrasound for 5 minutes at bilateral acupuncture points of PC6, PC7, BL60 and KI1(3 times / week for 4 weeks).

patients were received placebo therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI.

OTHERTraditional physical therapy program

Strengthing exercise, balance training, stretching exercises and home exercise program and education

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain level assessment2.5 monthsIn comfortable siting position we asked them to give each item from the 10-items score from 0 to 10 according to the intensity of the symptom, 0 means that the symptom is absent and 10 means maximum intensity. Sum of scores is 100, a higher score is associated with increased pain
Assessment of pain pressure threshold2.5 monthsPain pressure threshold at hand and foot was measured by using a digital pressure algometer with a probe of 1 cm2 .PPT at feets was measured on the plantar foot surface over the second metatarsal. PPT at hands was measured on thenar eminence of the hand

Secondary

MeasureTime frameDescription
National Cancer Institute Common Toxicity Criteria2.5 monthsNCI CTC are set of medical terms very useful for the classification of adverse events related to cytotoxic drugs. These terms are not international codes for reporting adverse events to the Health Authorities. They are very frequently used in handling adverse events from oncology trials

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026