Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Standard Care (Behavioral)
Standard Care
Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.
Intervention: Standard Care (Behavioral)
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.
Intervention: Ultrasound Therapy (Other)
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
Time Frame: 6 weeks
Change in pain and sensory disturbance
Secondary Outcomes
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3(6 weeks)
- Balance Assessment(6 weeks)
- Protective sensation(6 weeks)
- Temperature sensation(6 weeks)
- Vibration sensation(6 weeks)
- Reflexes(6 weeks)
Investigators
Margie McNeely
Associate Professor
University of Alberta