A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy

IIT2019-07-ASHER-QIGONG: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy

This pilot study will include up to 25 patients with cancer experiencing chemotherapy-induced peripheral neuropathy. Patients enrolled in the study will participate in a 10-week QiGong for Chemotherapy-Induced Neuropathy program. Patients will be evaluated before and after their program participation. Within 2 weeks before the program start date, patients will be administered an objective neuropathy assessment by a physician or nurse, and will complete questionnaires assessing chemotherapy-induced peripheral neuropathy, perceived cognitive functioning, quality of life, and cancer-related symptoms. Patients will repeat these assessments at the end of the last QiGong class and will be asked to provide feedback on the QiGong program as a whole. Self-report questionnaires will also be repeated one week after the last class.

Total duration of subject participation will be 11-13 weeks. Total duration of the study is expected to be approximately 9 months.

Inclusion Criteria:

• Diagnosed with cancer, stage 1-4.
• Completed taxane- or platinum-based chemotherapy at least three months (90 days) ago but within 24 months of signing consent. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay.
• Experiencing at least grade 1 peripheral sensory neuropathy, peripheral motor neuropathy, or dysesthesias based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 (NCI CTCAE v4.0).
• Age ≥ 18 years.
• Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to study enrollment).
• Reasonable functional stability as assessed by the evaluating physician.
• Must be able to understand and communicate proficiently in English.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

• Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician.
• Medical history of neuropathy from any type of nerve compression (e.g., carpal tunnel or tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy, leptomeningeal carcinomatosis), as assessed by the treating physician.
• Neuropathy related to abnormal TSH or B12 levels as assessed by treating physician
• Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician.
• Severe personality disorder or psychiatric disorder that would interfere with participation in a QiGong program, as assessed by the evaluating physician.
• Currently participating in another QiGong or Tai Chi program.