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

Margie McNeely

Status: Completed

Conditions: Colon Neoplasms; Colorectal Neoplasms

Treatments: Behavioral: Standard Care; Other: Ultrasound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02499939

HREBA-CC-15-0107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Care

Experimental: Ultrasound Therapy

Experimental group

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.

Treatment:

Other: Ultrasound Therapy

Behavioral: Standard Care