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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Supportive Care
  • Masking: Single (Outcomes Assessor)
• Study Primary Completion Date: September 30, 2017

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.

Interventions

• 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.)

Arms, Groups and Cohorts

• Active Comparator: Standard Care
  • Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.
• Experimental: Experimental: Ultrasound Therapy
  • Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home. Participants in this group will also undergo 10 daily treatments of ultrasound therapy (e.g., Monday to Friday for two weeks) that is administered to their toes and fingers. The ultrasound therapy will be administered over the first two weeks of the intervention period.

Clinical Trial Outcome Measures

Primary Measures

• Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
  • Time Frame: 6 weeks
  • Change in pain and sensory disturbance

Secondary Measures

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3
  • Time Frame: 6 weeks
  • Change in quality of life and symptoms related to chemotherapy induced peripheral nerve injury
• Protective sensation
  • Time Frame: 6 weeks
  • Change in protective sensation: using a 10g monofilament for the feet and 6g for the hands to determine presence or absence of protective sensation.
• Temperature sensation
  • Time Frame: 6 weeks
  • Change in temperature sensation: hot and cold test tubes will be applied to the feet and hands to determine ability to distinguish hot and cold sensations.
• Vibration sensation
  • Time Frame: 6 weeks
  • Change in vibration sensation: A 128 Hz tuning fork will be applied to the big toe, medial malleolus, thumb and ulnar styloid to determine presence/ absence of vibration sensation.
• Reflexes
  • Time Frame: 6 weeks
  • Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex
• Balance Assessment
  • Time Frame: 6 weeks
  • Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.

Participating in This Clinical Trial

Inclusion Criteria

1. adults18 or older, 2. receiving or have received chemotherapy treatment for colon or colorectal cancer, 3. chemotherapy regimen includes the agent oxaliplatin, 4. Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy. Exclusion Criteria:

1. neuropathy pre-existing the patient's cancer diagnosis; 2. contraindications to therapeutic ultrasound:

• active cancer in region of hands or feet, – presence of deep vein thrombosis, – lack of sensation in hands or feet, – metal or plastic implants in hands or feet; 3. peripheral vascular disease or other serious existing non-malignant disease which may affect their ability to complete testing and treatment sessions.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Margie McNeely
• Collaborator
  • Cross Cancer Institute
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Margie McNeely, Associate Professor – University of Alberta
• Overall Official(s)
  • Janice Yurick, BSc, Principal Investigator, Alberta Health services