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

NCT06725043 | Completed DMC

• 1 other identifier: Ultrasound Acupuncture for OIP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

oxaliplatin; peripheral neuropathy; ultrasound acupuncture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• National Cancer Institute Common Toxicity Criteria

  2.5 months

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Device: Therapeutic ultrasound; Other: Traditional physical therapy program

Experime

PLACEBO COMPARATOR

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

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

Interventions

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).

Active

Placebo therapeutic ultrasound DEVICE

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

Experime

Traditional physical therapy program OTHER

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

Active; Experime

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Suez Canal University

Ismailia, Ismalia, 41616, Egypt

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 10, 2024
• Study Start: July 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 3, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)