Colon NeoplasmsULTRANCT02499939
Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN)
A study testing Ultrasound Therapy in people with Colon Neoplasms and Colorectal Neoplasms, run by Margie McNeely at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Neoplasms, Colorectal Neoplasms
- What is being tested?
- Ultrasound Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6J4P9
About this study
Official title: Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial
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.
Read the 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
- Being tested
- Standard Care, Ultrasound Therapy
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Education and home exercises
Ultrasound TherapyOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home. Receives: 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. Receives: Behavioral: Standard Care; Other: Ultrasound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
Change in pain and sensory disturbance
Measured: 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
Change in quality of life and symptoms related to chemotherapy induced peripheral nerve injury
Measured: 6 weeks
Protective sensation
Change in protective sensation: using a 10g monofilament for the feet and 6g for the hands to determine presence or absence of protective sensation.
Measured: 6 weeks
Temperature sensation
Change in temperature sensation: hot and cold test tubes will be applied to the feet and hands to determine ability to distinguish hot and cold sensations.
Measured: 6 weeks
Vibration sensation
Change in vibration sensation: A 128 Hz tuning fork will be applied to the big toe, medial malleolus, thumb and ulnar styloid to determine presence/ absence of vibration sensation.
Measured: 6 weeks
Reflexes
Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex
Measured: 6 weeks
Balance Assessment
Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start10 Feb 2016
- Primary completion30 Sep 2017
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margie McNeely
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor-investigator, Margie McNeely, University of Alberta
- Investigators
- Janice Yurick, BSc, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499939
- Sponsor's protocol ID
- HREBA-CC-15-0107
- Acronym
- ULTRA
- Status last verified
- Apr 2018
- First submitted
- 14 Jul 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33137422
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02499939
- Acronym / sponsor ID
- ULTRA / HREBA-CC-15-0107
- Conditions
- Colon Neoplasms, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Margie McNeelyUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareParticipants in this group will receive standard education about CIPN and therapeutic exercises to carry out at home. |
| Experimental: Ultrasound Therapy | Experimental | Behavioral: Standard Care, Other: Ultrasound TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- neuropathy pre-existing the patient's cancer diagnosis;
- contraindications to therapeutic ultrasound:
- peripheral vascular disease or other serious existing non-malignant disease which may affect their ability to complete testing and treatment sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareEducation and home exercises | Behavioural | Experimental: Ultrasound Therapy, Standard Care |
| Ultrasound TherapyUltrasound 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.) | Other | Experimental: Ultrasound Therapy |
Primary outcome
Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale
Time frame: 6 weeks
Change in pain and sensory disturbance
6 secondary outcomes
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3
Time frame: 6 weeks
Protective sensation
Time frame: 6 weeks
Temperature sensation
Time frame: 6 weeks
Vibration sensation
Time frame: 6 weeks
Reflexes
Time frame: 6 weeks
Balance Assessment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 33137422Al 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.
- Individual participant dataSharing planned: No
Related trials for Colon Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Yurick, BSc principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Therapy in people with Colon Neoplasms and Colorectal Neoplasms, run by Margie McNeely at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02499939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.