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

Colorectal Neoplasms Clinical Trial

— ULTRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499939
• Other study ID #: HREBA-CC-15-0107
• Status: Completed
• Phase: N/A
• Start date: February 10, 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: April 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 1, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Neoplasms
• Colonic Neoplasms
• Colorectal Neoplasms
• Neoplasms
• Peripheral Nervous System Diseases

Intervention

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.)

Locations

Country	Name	City	State
Canada	University of Alberta/ Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Margie McNeely	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale	Change in pain and sensory disturbance	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Reflexes	Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex	6 weeks
Secondary	Balance Assessment	Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.	6 weeks