Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05357469
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
Study:
NCT05357469
Study Brief:
Protocol Section:
NCT05357469