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

NCT ID: NCT02499939

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-10
• Study Completion Date: 2018-07-01

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.

Conditions

Colon Neoplasms; Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard Care

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

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

Education and home exercises

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.

Group Type: EXPERIMENTAL

Standard Care

Intervention Type: BEHAVIORAL

Education and home exercises

Ultrasound Therapy

Intervention Type: 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.)

Interventions

Standard Care

Education and home exercises

Intervention Type: BEHAVIORAL

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.)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross Cancer Institute

OTHER

Sponsor Role: collaborator

Margie McNeely

OTHER

Sponsor Role: lead

Responsible Party

Margie McNeely

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Janice Yurick, BSc

Role: PRINCIPAL_INVESTIGATOR

Alberta Health services

Locations

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33137422 (View on PubMed)

Other Identifiers

HREBA-CC-15-0107

Identifier Type: -

Identifier Source: org_study_id