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

Margie McNeely31 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Colon Neoplasms Colorectal Neoplasms

Interventions

Standard CareBEHAVIORAL

Education and home exercises

Ultrasound TherapyOTHER

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.)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale

Change in pain and sensory disturbance

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 weeks

Reflexes

Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex

Time frame: 6 weeks

Balance Assessment

Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.

Data from ClinicalTrials.gov

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