NCT02499939

Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN)

Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Margie McNeely · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the trial is to determine the preliminary efficacy of therapeutic ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced peripheral neuropathy.

Detailed description

Thirty cancer patients with colon or colorectal cancer undergoing chemotherapy treatment including the agent oxaliplatin will take part in the study. Patients will be randomly assigned to either standard care alone (education and therapeutic exercises) or standard care plus 10 treatments of therapeutic ultrasound to the toes and fingers. Participants in both groups will follow a home exercise program for a 6 week period. Therapeutic ultrasound will be administered daily (e.g., Monday to Friday) over the first two week period of the study.

Conditions

• Colon Neoplasms
• Colorectal Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	Standard Care	Education and home exercises
OTHER	Ultrasound Therapy	Ultrasound is a therapeutic modality that is used by physical therapists to help reduce local tissue pain and inflammation. Ultrasound is applied using a round-headed wand or probe that is placed in direct contact with the patient's skin. Ultrasound gel is used on all surfaces of the ultrasound head to reduce friction and assist in the transmission of the ultrasonic waves. For the purposes of treatment for CIPN, the ultrasound will be applied for 5 minutes to each limb (right toes, left toes, right fingers, left fingers) at frequency of 3.0 megahertz (MHz) and an intensity of 0.7-0.8 watts per cm2. (For CIPN, the ultrasound will be administered at a lower intensity in order to avoid a heating effect on the tissues.)

Timeline

• Start date: 2016-02-10
• Primary completion: 2017-09-30
• Completion: 2018-07-01
• First posted: 2015-07-16
• Last updated: 2018-10-15

Locations

1 site across 1 country: Canada