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NCT Number: NCT06725043

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

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

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Key information

Conditions

Colorectal Cancer Patients and Their Partners Nervous System Diseases Neuromuscular Diseases Oxaliplatin-induced Peripheral Neuropathy Peripheral Nervous System Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Suez Canal University

Ismailia, Ismalia, 41616, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic Ultrasound

Device

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).

Placebo therapeutic ultrasound

Device

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

Traditional physical therapy program

Other

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

Primary outcomes

  1. Pain level assessment

    Time frame: 2.5 months

    In 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

  2. Assessment of pain pressure threshold

    Time frame: 2.5 months

    Pain 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 outcomes

  1. National Cancer Institute Common Toxicity Criteria

    Time frame: 2.5 months

    NCI 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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