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.

Study Overview

• Status: Completed
• Conditions: Oxaliplatin-induced Peripheral Neuropathy; Colorectal Cancer Patients and Their Partners
• Intervention / Treatment: Device: Therapeutic ultrasound; Other: Traditional physical therapy program; Device: Placebo therapeutic ultrasound

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismalia
    • Ismailia, Ismalia, Egypt, 41616
      • Faculty of Physical Therapy, Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Therapeutic ultrasound (1 MHz) Pulsed mode at bilateral acupuncture points of PC6, PC7, BL60 andKI1	Device: Therapeutic 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).; Other: Traditional physical therapy program; Strengthing exercise, balance training, stretching exercises and home exercise program and education
Placebo Comparator: Experime; Placebo Therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI1	Other: Traditional physical therapy program; Strengthing exercise, balance training, stretching exercises and home exercise program and education; Device: Placebo therapeutic ultrasound; patients were received placebo therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level assessment	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	2.5 months
Assessment of pain pressure threshold	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	2.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Cancer Institute Common Toxicity Criteria	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	2.5 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): December 3, 2024

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 7, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: oxaliplatin; peripheral neuropathy; ultrasound acupuncture
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: Ultrasound Acupuncture for OIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No