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

NCT ID: NCT06725043

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-03

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

Conditions

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

Keywords

oxaliplatin; peripheral neuropathy; ultrasound acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active

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

Group Type: ACTIVE_COMPARATOR

Therapeutic ultrasound

Intervention Type: 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).

Traditional physical therapy program

Intervention Type: OTHER

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

Experime

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

Group Type: PLACEBO_COMPARATOR

Placebo therapeutic ultrasound

Intervention Type: DEVICE

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

Traditional physical therapy program

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: DEVICE

Placebo therapeutic ultrasound

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

Intervention Type: DEVICE

Traditional physical therapy program

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hend Ali Mahmoud Ibrahim Badr Al-din

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy, Suez Canal University

Ismailia, Ismalia, Egypt

Countries

Egypt

Other Identifiers

Ultrasound Acupuncture for OIP

Identifier Type: -

Identifier Source: org_study_id