Effect of Scramble Therapy on Chemotherapy Induced Peripheral Neuropathic Pain: A Prospective, Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Chemotherapy induced peripheral neuropathic pain (CIPN) score difference
Study Overview
Brief Summary
This trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. Scrambler therapy is a type of treatment that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of MC5-A scrambler therapy (scrambler therapy [ST]) in reducing chemotherapy-induced painful peripheral neuropathy (CIPPN).
II. Evaluate the change in pain score before and after 2 weeks (Monday-Friday) of the final ST treatment.
III. Assess for changes in other symptom burden (i.e insomnia, feeling of well-being, depression and anxiety) after 2 weeks (Monday-Friday) ST treatment.
SECONDARY OBJECTIVES:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a diagnosis of cancer and suffer from CIPN for at least 3 months after the end of their last cancer chemotherapy
- •Have average pain intensity of at least 4/10
- •Be in stable clinical situation (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled) in the month following the enrollment)
- •Can give a written informed consent
Exclusion Criteria
- •Pre-existence or history of seizure
- •Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy (i.e. idiopathic peripheral neuropathy, diabetic neuropathy
- •Pregnancy
- •Present with pacemaker or implantable defibrillators
- •Present or past psychotropic substances and alcohol dependence
- •Inability to understand patients' information and informed consent
- •Skin lesion at the electrode placement site
Arms & Interventions
Supportive Care (scrambler therapy, sensory test, gait test)
Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.
Intervention: Quality-of-Life Assessment (Other)
Supportive Care (scrambler therapy, sensory test, gait test)
Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.
Intervention: FitBit (Device)
Supportive Care (scrambler therapy, sensory test, gait test)
Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.
Intervention: Gait Assessment Test (Other)
Supportive Care (scrambler therapy, sensory test, gait test)
Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.
Intervention: MC5-A Scrambler Therapy (Other)
Supportive Care (scrambler therapy, sensory test, gait test)
Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.
Intervention: Quantitative Sensory Testing (Procedure)
Supportive Care (scrambler therapy, sensory test, gait test)
Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
Chemotherapy induced peripheral neuropathic pain (CIPN) score difference
Time Frame: Baseline to the last day of 2-week treatment
Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
Secondary Outcomes
- Change in therapy-induced neuropathy(Baseline to the last day of 2-week treatment)
- Change in cancer-related symptoms(Baseline to the last day of 2-week treatment)
- Change in physical function and quality of life(Baseline to the last day of 2-week treatment)