An Early Phase 1 interventional study of Quality-of-Life Assessment and Questionnaire Administration in Chemotherapy-Induced Peripheral Neuropathy and Malignant Neoplasm, sponsored by M.D. Anderson Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by M.D. Anderson Cancer Center · Early Phase 1, Interventional, and Supportive care
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.
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.
9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.
Browse Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 579 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion:
Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Procedure: Transcranial Direct Current Stimulation
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Undergo tDCS
Also known as: tDCS
Change in chemotherapy induced peripheral neuropathy pain score
The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
Time frame: Baseline up to final day of treatment (3 weeks)
Change in total opioid requirement (morphine equivalent daily dosage)
Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs.
Time frame: Baseline up to 4-6 weeks post-treatment
Change in cancer related symptoms
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).
Time frame: Baseline up to 4-6 weeks post-treatment
Change in functioning of Daily Activities
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).
Time frame: Baseline up to 4-6 weeks post-treatment
Change in quality of life questionnaire
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).
Time frame: Baseline up to 4-6 weeks post-treatment
Incidence of adverse events
Frequency counts and percentages will be documented.
Time frame: Up to 4-6 weeks post-treatment
Documents are hosted by the registry — open the source record to download them.
This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center