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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02499939
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
Margie McNeely, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Colon Neoplasms Colorectal Neoplasms Behavioral: Standard Care Other: Ultrasound Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial
Actual Study Start Date : February 10, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Care
Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.
Behavioral: Standard Care
Education and home exercises

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.
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.)





Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale [ Time Frame: 6 weeks ]
    Change in pain and sensory disturbance


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499939


Locations
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Canada, Alberta
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada, T6J4P9
Sponsors and Collaborators
Margie McNeely
Cross Cancer Institute
Investigators
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Principal Investigator: Janice Yurick, BSc Alberta Health Services

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Responsible Party: Margie McNeely, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02499939    
Other Study ID Numbers: HREBA-CC-15-0107
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases