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

Not Applicable

Completed

• Conditions: Colon Neoplasms; Colorectal Neoplasms
• Interventions: Behavioral: Standard Care; Other: Ultrasound Therapy

• Registration Number: NCT02499939
• Lead Sponsor: Margie McNeely

Brief 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.

Study Timeline

• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Start: 2016-02-10
• Primary Completion: 2017-09-30
• Status Verified: 2018-04
• Study Completion: 2018-07-01
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Ultrasound Therapy	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.
Standard Care	Standard Care	Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.
Experimental: Ultrasound Therapy	Standard Care	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3	6 weeks	Change in quality of life and symptoms related to chemotherapy induced peripheral nerve injury
Protective sensation	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	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	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	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	6 weeks	Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.

Trial Locations

Locations (1)

University of Alberta/ Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada