Chemotherapy-Induced Peripheral Neuropathy, Malignant Neoplasm
Conditions
Brief summary
This early phase I trial studies how well transcranial direct current stimulation works in reducing pain in cancer patients with chemotherapy induced peripheral neuropathy. Transcranial direct current stimulation is used for patients with brain injuries such as strokes as well as for mental health issues such as depression and may help to control pain in cancer patients with chemotherapy induced peripheral neuropathy.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing chemotherapy induced painful peripheral neuropathy (CIPPN). Ia. Evaluate the change in pain scores Ib. Assess for changes in other symptoms (i.e insomnia, feeling of well-being, depression and anxiety). SECONDARY OBJECTIVES: I. To evaluate the following with the treatment of tDCS: Ia. Assess for changes in using pain medications. Ib. Assess for changes in functioning (daily activities). Ic. Assess for changes in quality of life. Id. Assess for changes in neuropathy. Ie. Assess overall satisfaction with the tDCS treatment. TERTIARY OBJECTIVES: I. To evaluate tDCS treatment related side-effects. OUTLINE: Patients undergo tDCS once daily (QD) over 20 minutes 5 days each week (Monday-Friday) for 3 weeks. After completion of study treatment, patients are followed up weekly for 3 weeks and at 4-6 weeks.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURETranscranial Direct Current Stimulation
Undergo tDCS
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Age greater than or equal to 18 years. * Able to give a Voluntary written consent. * Cancer patients with chemotherapy induced peripheral neuropathy of at least 3 months duration.. * Pain and/or tingling of at least 4/10 Exclusion: * History of seizure * History of migraine headache * History of brain cancer and/or brain metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in chemotherapy induced peripheral neuropathy pain score | Baseline up to final day of treatment (3 weeks) | The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total opioid requirement (morphine equivalent daily dosage) | Baseline up to 4-6 weeks post-treatment | Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs. |
| Change in cancer related symptoms | Baseline up to 4-6 weeks post-treatment | We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst). |
| Change in functioning of Daily Activities | Baseline up to 4-6 weeks post-treatment | We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst). |
| Change in quality of life questionnaire | Baseline up to 4-6 weeks post-treatment | We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst). |
| Incidence of adverse events | Up to 4-6 weeks post-treatment | Frequency counts and percentages will be documented. |
Countries
United States
Outcome results
None listed