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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08323 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0651 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
I. To evaluate the following with the treatment of ST:
Ia. Assess for changes in therapy induced neuropathy assessment scale (TNAS). Ib. Assess for changes in using pain medications. Ic. Assess for changes in daily physical activities/functional status. Id. Assess for changes in quality of life using European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (chemotherapy induced peripheral neuropathy) chemotherapy-induced neuropathic pain (CIPN) 20 questionnaire.
Ie. Assess overall satisfaction with the ST treatment using Global Impression of Change questionnaire.
TERTIARY (EXPLORATORY) OBJECTIVE:
I. Determine the change in sensation after 2 weeks (Monday-Friday) of the final ST treatment.
OUTLINE:
Patients undergo scrambler therapy over 30-45 minutes once daily (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.
After completion of study, patients are followed up weekly for 3 weeks and at 4 weeks after the last day of scrambler therapy treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (scrambler therapy, sensory test, gait test) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FitBit | Device | Wear FitBit for gait assessment test |
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| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy induced peripheral neuropathic pain (CIPN) score difference | 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). | Baseline to the last day of 2-week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in therapy-induced neuropathy | Will be assessed using therapy induced neuropathy assessment scale. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salahadin Abdi | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Gait Assessment Test | Other | Undergo gait assessment test |
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| MC5-A Scrambler Therapy | Other | Undergo scrambler therapy |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Quantitative Sensory Testing | Procedure | Undergo quantitative sensory test |
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| Questionnaire Administration | Other | Ancillary studies |
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| Baseline to the last day of 2-week treatment |
| Change in cancer-related symptoms | Will be assessed using therapy induced neuropathy assessment scale. 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. | Baseline to the last day of 2-week treatment |
| Change in physical function and quality of life | Will be assessed using the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire CIPN20 questionnaire. 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). | Baseline to the last day of 2-week treatment |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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