Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer

University of Michigan

Status: Completed

Conditions: Cancer of Head and Neck

Treatments: Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02366611

U036889 (Other Identifier)

HUM 78942

Details and patient eligibility

About

The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS) can reduce pain perception associated with the effects of receiving definitive radiation therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.

Full description

The goal of this study is to investigate the effectiveness of tDCS as a novel pain relief modality for odynophagia due to mucositis in patients with locally advanced head and neck cancer undergoing definitive radiation therapy or chemoradiotherapy. Participants will be randomized into one of two arms: (1) Treatment: radiation/chemoradiotherapy standard of care + tDCS neuromodulation or (2) Control: radiation/chemoradiotherapy standard of care only.

Patients in the treatment arm will undergo tDCS stimulation on the day of their radiation/chemoradiotherapy appointments, prior to receiving treatment when doing tDCS session in clinic or after to receiving treatment when doing tDCS session at home. This will occur daily (5 days per week) during the second and third weeks of therapy, three times per week during the fourth and fifth weeks, and twice per week during the sixth and seventh weeks.

Patients will also have EEG and fNIRS recordings during the study. This will occur at the pre-study visit, the first stimulation appointment, the third week, the 7th week, and during the follow-up appointments (one-week and one-month).

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with AJCC stage III-IV head and neck malignancy scheduled for definitive radiation therapy or chemoradiotherapy, and who are capable of understanding and adhering to the protocol requirements.

Exclusion criteria

• Substantial dementia
• Patients are actively being treated for another cancer at the time of enrollment.
• Any condition that would prevent use of tDCS including skull abnormality, implanted metal, implanted electronic device, seizure disorder, neurologic condition.
• Use of an investigational drug or device within 30 days of study screening

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Transcranial Direct Current Stimulation (tDCS)

Experimental group

Description:

tDCS is a method of non-invasive brain stimulation that is based on the application of a weak direct current to the head that flows between two relatively large electrodes-anode and cathode. tDCS offers a unique analgesic modality of central pain neuromodulation by altering the activity of key sensory and motor cortical structures. Participants in this arm will undergo 20 tDCS sessions, tDCS in clinic and remotely supervised tDCS, and 2mA of transcranial direct current stimulation will be applied for 20 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Chemoradiotherapy Standard of Care

No Intervention group

Description:

The control group will consist of patients receiving the Standard of care and no neuromodulation.