Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- 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.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Salahadin Abdi, MD
sabdi@mdanderson.org
(713) 792-0883
Time Frame
Start Date: 2022-07-14
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 38
Treatments
Experimental: Immediate St (Scrambler Therapy)
Participant will start ST (Scrambler Therapy) treatment right away.
Experimental: Waitlist ST (Scrambler Therapy)
Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov