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

NCT02499939 | Completed

• 1 other identifier: HREBA-CC-15-0107
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Neoplasms; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale

  Change in pain and sensory disturbance

  6 weeks

Secondary Outcomes (6)

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3

  6 weeks

• Protective sensation

  6 weeks

• Temperature sensation

  6 weeks

• Vibration sensation

  6 weeks

• Reflexes

  6 weeks

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home.

Behavioral: Standard Care

Experimental: Ultrasound Therapy

EXPERIMENTAL

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; Other: Ultrasound Therapy

Interventions

Standard Care BEHAVIORAL

Education and home exercises

Experimental: Ultrasound Therapy; Standard Care

Ultrasound Therapy OTHER

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.)

Experimental: Ultrasound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Margie McNeely: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6J4P9, Canada

Location

Related Publications (1)

• 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.

  PMID: 33137422 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Interventions

Standard of Care; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Janice Yurick, BSc

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 16, 2015
• Study Start: February 10, 2016
• Primary Completion: September 30, 2017
• Study Completion: July 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)