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

Study Overview
=================
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.

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

Conditions
-----------------
Colon Neoplasms, Colorectal Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Standard Care
* Other: Ultrasound Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults18 or older, receiving or have received chemotherapy treatment for colon or colorectal cancer, chemotherapy regimen includes the agent oxaliplatin, Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy. Exclusion Criteria: neuropathy pre-existing the patient's cancer diagnosis; 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; peripheral vascular disease or other serious existing non-malignant disease which may affect their ability to complete testing and treatment sessions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home. | Behavioral: Standard Care<br>* Education and home exercises<br>|
| Experimental: Experimental: Ultrasound Therapy<br>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. | Behavioral: Standard Care<br>* Education and home exercises<br>Other: Ultrasound Therapy<br>* 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.)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale | Change in pain and sensory disturbance | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3 | Change in quality of life and symptoms related to chemotherapy induced peripheral nerve injury | 6 weeks | 
| Protective sensation | Change in protective sensation: using a 10g monofilament for the feet and 6g for the hands to determine presence or absence of protective sensation. | 6 weeks | 
| Temperature sensation | 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. | 6 weeks | 
| Vibration sensation | 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. | 6 weeks | 
| Reflexes | Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex | 6 weeks | 
| Balance Assessment | Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed. | 6 weeks |