A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy (QiGong)

Arash Asher, MD

Status

Terminated

Conditions

Chemotherapy-induced Peripheral Neuropathy

Cancer

Treatments

Other: Qi Gong

Study type

Interventional

Funder types

Other

Identifiers

NCT04185610

IIT2019-07-ASHER-QIGONG

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.