Back to resultsUltrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) (ULTRA)
Primary Purpose
Colon Neoplasms, Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard Care
Ultrasound Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Colon Neoplasms
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.
Sites / Locations
- University of Alberta/ Cross Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Care
Experimental: Ultrasound Therapy
Arm Description
Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.
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.
Outcomes
Primary Outcome Measures
Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
Change in pain and sensory disturbance
Secondary Outcome Measures
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
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.
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.
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.
Reflexes
Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex
Balance Assessment
Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.
Full Information
NCT ID
NCT02499939
First Posted
July 14, 2015
Last Updated
October 11, 2018
Sponsor
Margie McNeely
Collaborators
Cross Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02499939
Brief Title
Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 10, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Margie McNeely
Collaborators
Cross Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Neoplasms, Colorectal Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.
Arm Title
Experimental: Ultrasound Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Education and home exercises
Intervention Type
Other
Intervention Name(s)
Ultrasound Therapy
Intervention Description
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 Measure Information:
Title
Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
Description
Change in pain and sensory disturbance
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3
Description
Change in quality of life and symptoms related to chemotherapy induced peripheral nerve injury
Time Frame
6 weeks
Title
Protective sensation
Description
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
Title
Temperature sensation
Description
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
Title
Vibration sensation
Description
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
Title
Reflexes
Description
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
Title
Balance Assessment
Description
Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Yurick, BSc
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta/ Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6J4P9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33137422
Citation
Al Onazi MM, Yurick JL, Harris C, Nishimura K, Suderman K, Pituskin E, Chua N, McNeely ML. Therapeutic Ultrasound for Chemotherapy-Related Pain and Sensory Disturbance in the Hands and Feet in Patients With Colorectal Cancer: A Pilot Randomized Controlled Trial. J Pain Symptom Manage. 2021 Jun;61(6):1127-1138. doi: 10.1016/j.jpainsymman.2020.10.028. Epub 2020 Nov 1.
Results Reference
derived
Learn more about this trial
Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN)
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