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Behavioural Intervention

Scrambler Therapy for Peripheral Neuropathy

N/A
Recruiting
Led By Salahadin Abdi, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy
Patients who have had cancer and are not being actively treated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will investigate whether Scrambler therapy is effective in reducing pain and chemotherapy-induced peripheral neuropathy in adolescents and young adults with cancer, as well as the impact of this therapy on physical functioning and quality of life.

Who is the study for?
This trial is for English-speaking adolescents and young adults aged 15-39 who have had cancer, are not currently in active treatment, and suffer from moderate to severe chemotherapy-induced painful peripheral neuropathy (pain level ≥4). They must be able to complete questionnaires with or without assistance. Those with mobility issues, brain or bone metastases affecting movement, prior Scrambler Therapy, certain implants, epilepsy, skin damage where electrodes would go, or other pain conditions are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Scrambler Therapy on reducing pain from chemotherapy-induced peripheral neuropathy and improving physical function and quality of life. Participants will be randomly assigned to either receive immediate therapy or placed on a waitlist (control group) in this prospective randomized controlled trial.See study design
What are the potential side effects?
While specific side effects of Scrambler Therapy aren't detailed here, it's generally considered non-invasive with minimal risks. Potential discomfort may arise from electrode placement on the skin depending on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience moderate to severe pain or neuropathy from chemotherapy.
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I had cancer but am not currently receiving treatment.
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I am between 15 and 39 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waitlist ST (Scrambler Therapy)Experimental Treatment1 Intervention
Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.
Group II: Immediate St (Scrambler Therapy)Experimental Treatment1 Intervention
Participant will start ST (Scrambler Therapy) treatment right away.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,352 Total Patients Enrolled
4 Trials studying Peripheral Neuropathy
197 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,816 Total Patients Enrolled
13 Trials studying Peripheral Neuropathy
1,435 Patients Enrolled for Peripheral Neuropathy
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,838 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
301 Patients Enrolled for Peripheral Neuropathy

Media Library

Scrambler Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05357469 — N/A
Peripheral Neuropathy Research Study Groups: Immediate St (Scrambler Therapy), Waitlist ST (Scrambler Therapy)
Peripheral Neuropathy Clinical Trial 2023: Scrambler Therapy Highlights & Side Effects. Trial Name: NCT05357469 — N/A
Scrambler Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05357469 — N/A
Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT05357469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this clinical trial presently?

"According to the clinicaltrials.gov website, this trial is currently seeking participants who meet its criteria. The study was first launched on July 14th 2022 and has been recently revised on October 13th 2022."

Answered by AI

How many participants have been enlisted in this trial thus far?

"Affirmative. According to clinicaltrials.gov, this experiment was posted on July 14th 2022 and is actively searching for 38 participants from a single medical site. The listing has been recently updated as of October 13th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
Missouri
Michigan
How old are they?
< 18
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've dealt with chronic nerve pain in both feet and ankles since 2006. I've tried many drugs with limited success.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
2022. "Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05357469.
All > Neuropathy > Peripheral Neuropathy
~11 spots leftby Jan 2025
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