Clinical trial NCT02499939: Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN)
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
Overall status: COMPLETED
Phase: NA
Conditions: Colon Neoplasms
Colorectal Neoplasms
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2015-07-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
timeFrame: 6 weeks
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3
timeFrame: 6 weeks
measure: Protective sensation
timeFrame: 6 weeks
measure: Temperature sensation
timeFrame: 6 weeks
measure: Vibration sensation
timeFrame: 6 weeks
measure: Reflexes
timeFrame: 6 weeks
measure: Balance Assessment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Janice Yurick, BSc
role: PRINCIPAL_INVESTIGATOR
References:
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.