Clinical trial NCT04135326: Transcranial Direct Current Stimulation in Reducing Pain in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy
Official title: Transcranial Direct Current Stimulation (tDCS) to Reduce Pain in Patients With Chemotherapy Induced Peripheral Neuropathy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in chemotherapy induced peripheral neuropathy pain score
timeFrame: Baseline up to final day of treatment (3 weeks)
Secondary outcomes:
measure: Change in total opioid requirement (morphine equivalent daily dosage)
timeFrame: Baseline up to 4-6 weeks post-treatment
measure: Change in cancer related symptoms
timeFrame: Baseline up to 4-6 weeks post-treatment
measure: Change in functioning of Daily Activities
timeFrame: Baseline up to 4-6 weeks post-treatment
measure: Change in quality of life questionnaire
timeFrame: Baseline up to 4-6 weeks post-treatment
measure: Incidence of adverse events
timeFrame: Up to 4-6 weeks post-treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Salahadin Abdi
role: PRINCIPAL_INVESTIGATOR
References: