Breast Cancer Females
Conditions
Keywords
conventional repetitive transcranial magnetic stimulation, breast cancer, chemotherapy induced peripheral neuropathy
Brief summary
Laboratory studies have shown that prolonged continuous theta burst stimulation (pcTBS) provides better pain relief than 10 Hz repetitive transcranial magnetic stimulation (rTMS), with a shorter stimulation time, making it more practical for clinical use. Chemotherapy-induced peripheral neuropathy often causes neuropathic pain in cancer patients. The aims of this study are: 1. To compare the effects of pcTBS and 20 Hz rTMS on chemotherapy-induced peripheral neuropathy; 2. To compare the effects of pcTBS applied to the primary motor cortex versus the dorsolateral prefrontal cortex on neuropathic pain as well as depression and anxiety.
Detailed description
\*\*Phase 1:\*\* Investigators will recruit 20 breast cancer patients who have chemotherapy-induced peripheral neuropathy. They will be randomly divided into two groups. * Group 1 will first receive pcTBS. After an 8-week break, they will then receive 20 Hz rTMS. * Group 2 will receive the treatments in the opposite order. Each treatment lasts for 5 consecutive days. Before and after each treatment, patients will be assessed using: * A pain visual analog scale (to measure pain levels) * A Neuropathic Pain Symptom Inventory (The scale ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain) • \* A Depression Anxiety Stress Scale 21 (The scale ranges from 0-63, with a higher scores mean a worse outcome) o \* Clinical pressure pain threshold tests (Higher PPT values indicate a higher tolerance to pressure pain (less sensitivity). * Nerve conduction studies \*\*Phase 2:\*\* Another 20 breast cancer patients with chemotherapy-induced peripheral neuropathy will be recruited and randomly divided into two groups. * Group 1 will first receive pcTBS on the primary motor cortex. After an 8-week break, they will receive the same stimulation on the left dorsolateral prefrontal cortex. * Group 2 will receive the treatments in the opposite order.
Interventions
DEVICEprolonged continuous TBS
prolonged continuous theta burst stimulation
DEVICE20 Hz rTMS
20 Hz repetitive transcranial magnetic stimulation
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* breast cancer patients aged between 18- and 80-years-old with CIPN * history of receiving chemotherapy including taxane-based neurotoxic agents * with neuropathic pain, score≥3 in a 0-10 VAS pain scale. * with fair cognition and can cooperate to evaluate pain severity. * neither at end-stage cancer nor at the estimated survival time less than 6 months.
Exclusion criteria
* brain tumor or history of epilepsy * intracranial metallic devices, artificial cochleae, pacemakers, or any other metal device * recent myocardial ischemia or unstable angina * severe cognitive dysfunction or pregnancy * injuries or fractures in the part of neuropathic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue pain scale (VAS pain scale) | baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up | visual analogue pain scale (VAS) range from 0-100, with a higher score inducating more pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scale 21 | baseline and after completion the intervention and at 4 weeks follow-up | Depression Anxiety Stress Scale 21 scale ranges from 0-63, with a higher scores mean a worse outcome. |
| pressure pain threshold test | baseline and after completion the intervention and at 4 weeks follow-up | o Higher pressure pain threshold values indicate a higher tolerance to pressure pain (less sensitivity). |
| Neuropathic Pain Symptom Inventory | baseline and after completion the intervention and at 4 weeks follow-up | Neuropathic Pain Symptom Inventory ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain. |
Countries
Taiwan
Outcome results
None listed