Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
Primary Purpose
Peripheral Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate St (Scrambler Therapy)
Waitlist ST (Scrambler Therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria:
- - Both genders aged 15-39 years
- - Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy.
- - Patients have had cancer and are not being actively treated,
- - Patients who speaks English and able to complete questionnaires by themselves or with help from parents and/or nurses. Written informed consent will be obtained from adults (aged 18-39 years) or from parents/guardians of adolescents (aged 15-17 years) and assent will be obtained from adolescents (aged 15-17 years) under an Institutional Review Board (IRB)-approved protocol.
Exclusion Criteria:
- - Inability to walk or stand without assistance (need for ambulatory-assist devices)
- - Bone and/or central nervous system metastases that affect gait, walking and balance
- - History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions.
- Implanted intrathecal drug-delivery system or a spinal cord and/or peripheral nerve stimulator;
a) a metal implant such as a cardiac pacemaker, automatic defibrillator, aneurysm clips, vena cava clips, or skull plate.
- - History of epilepsy.
- - Skin damage at the site of electrode placement; and i) prior ST treatment; j) Patients on pain medications for other than CIPN.
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate St (Scrambler Therapy)
Waitlist ST (Scrambler Therapy)
Arm Description
Participant will start ST (Scrambler Therapy) treatment right away.
Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.
Outcomes
Primary Outcome Measures
The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)
Five functional scales (physical, role, cognitive, emotional, and social); nine symptom scales (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties); and a global health status/QoL. Based on 30 questions in total, the scores range from 0 to 100.
Secondary Outcome Measures
Full Information
NCT ID
NCT05357469
First Posted
April 27, 2022
Last Updated
September 19, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05357469
Brief Title
Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
Official Title
Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy and safety of Scrambler therapy (ST) for chemotherapy-induced painful peripheral neuropathy (CIPN), and the impact of ST on physical functioning and quality of life (QoL) in adolescents and young adults (AYA) cancer patients.
In this proposed study, we will conduct a two-arm prospective, randomized wait-list controlled clinical trial to investigate the effectiveness of ST on pain and CIPN in AYAs with cancer.
Detailed Description
Baseline Visit:
If you agree to take part in this study, you will have a Baseline Visit (a visit done before you begin receiving ST). At this visit:
You will have a physical exam. You will complete questionnaires about your symptoms, pain levels and how you think pain is affecting your life (such as your mood, ability to work, enjoyment of life, relationships with other people, and so on), quality of life, and your ability to walk and sleep. These questionnaires should take less than 30 minutes to complete. You will be asked about your pain medication use (including the name of the medications and how often you use them). You will complete a 6-Minute Walk Test. For this test, you will be asked to walk back and forth over a short distance as many times as you can for 6 minutes. This helps researchers measure your physical ability to walk and how well you can walk. You will have a sensory test to help researchers measure your touch sensation and your pain threshold for warm and cold temperatures. This test should take about 1 hour.
Study Groups and Scrambler Therapy:
After your Baseline Visit, you will be randomly assigned to 1 of 2 groups: Immediate ST or Waitlist ST. This is done because no one knows if one group is better, the same, or worse than the other. In Immediate ST, you will start ST treatment right away. In Waitlist ST, you will start ST treatment about 4 weeks after your Baseline Visit. You will have an equal chance (50/50) of being assigned to either group. The study staff will tell you which group you are in and when you will start treatment. You will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments). During each ST treatment session, about 2-10 pads, called electrodes, will be placed on your legs/feet or wrist/hands where you are experiencing pain, tingling, and/or numbness. A small electrical current will then be sent to the electrodes. At each session, you will receive the current for about 30-45 minutes.
Study Visits
Before each ST:
You will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. These should take about 5-10 minutes to complete. copies You will be asked about your pain medication use.
At each ST session:
You will have a physical exam. You will have a sensory test.
Every week for 4 weeks after ST is complete, you will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. You will also be asked about your pain medication use.
At Months 1, 2, and 3 after ST:
You will have a physical exam. You will have a sensory test. You will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. You will be asked about your pain medication use.
At the Month 3 visit only:
You will complete the questionnaire about your quality of life. You will complete a 6 Minute Walk Test. Your participation in this study will be over after the 3-month visit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate St (Scrambler Therapy)
Arm Type
Experimental
Arm Description
Participant will start ST (Scrambler Therapy) treatment right away.
Arm Title
Waitlist ST (Scrambler Therapy)
Arm Type
Experimental
Arm Description
Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.
Intervention Type
Device
Intervention Name(s)
Immediate St (Scrambler Therapy)
Intervention Description
Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).
Intervention Type
Device
Intervention Name(s)
Waitlist ST (Scrambler Therapy)
Intervention Description
Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).
Primary Outcome Measure Information:
Title
The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)
Description
Five functional scales (physical, role, cognitive, emotional, and social); nine symptom scales (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties); and a global health status/QoL. Based on 30 questions in total, the scores range from 0 to 100.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Both genders aged 15-39 years
- Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy.
- Patients have had cancer and are not being actively treated,
- Patients who speaks English and able to complete questionnaires by themselves or with help from parents and/or nurses. Written informed consent will be obtained from adults (aged 18-39 years) or from parents/guardians of adolescents (aged 15-17 years) and assent will be obtained from adolescents (aged 15-17 years) under an Institutional Review Board (IRB)-approved protocol.
Exclusion Criteria:
- Inability to walk or stand without assistance (need for ambulatory-assist devices)
- Bone and/or central nervous system metastases that affect gait, walking and balance
- History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions.
- Implanted intrathecal drug-delivery system or a spinal cord and/or peripheral nerve stimulator;
a) a metal implant such as a cardiac pacemaker, automatic defibrillator, aneurysm clips, vena cava clips, or skull plate.
- History of epilepsy.
- Skin damage at the site of electrode placement; and i) prior ST treatment; j) Patients on pain medications for other than CIPN.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salahadin Abdi, MD
Phone
(713) 792-0883
Email
sabdi@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salahadin Abdi, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salahadin Abdi, MD
Phone
713-792-0883
Email
sabdi@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Salahadin Abdi, MD
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
We'll reach out to this number within 24 hrs