Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
M.D. Anderson Cancer Center
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.
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 medicatio…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. \- Both genders aged 15-39 years 2. \- Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy. 3. \- Patients have had cancer and are not being actively treated, 4. \- 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 (I…
Interventions
- DeviceImmediate St (Scrambler Therapy)
Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).
- DeviceWaitlist ST (Scrambler Therapy)
Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).
Location
- M D Anderson Cancer CenterHouston, Texas