QiGong: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Qi Gong Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks |
Other: Qi Gong
Guided Qi Gong class
|
Outcome Measures
Primary Outcome Measures
- Objective Modified Total Neuropathy Scale (mTNS) score [10 weeks]
Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class)
- Subjective Neurotoxicity Subscale score [11 weeks]
Change in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up).
Secondary Outcome Measures
- Attendance [10 weeks]
Number of QiGong classes attended by those who enroll
- Retention [10 weeks]
Completion of both pre- and post-assessments
- Patient Interest [1 week]
Percentage of patients approached who sign consent
- Patient Evaluation of QiGong Program [1 day]
Scores on the evaluation titled: QiGong Program Evaluation. Study participants will provide a score for 3 questions related to the QiGong intervention. The minimum value is 0 and maximum value is 4, and higher score means a better outcome. Participants will also be asked 4 additional questions about the class. The minimum value is 0 and the maximum value is 10, and higher score means a better outcome. A composite of all the scores for each participant will be calculated, with higher scores indicating a better outcome.
- Perceived cognitive functioning [11 weeks]
Change in the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) score from Baseline to T1 (last day of class) and T2 (1-week follow-up).
- Physical Well-Being [11 weeks]
Change in the FACT/GOG-NTX Physical Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up).
- Social/Family Well-Being [11 weeks]
Change in the FACT/GOG-NTX Social/Family Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up).
- Emotional Well-Being [11 weeks]
Change in the FACT/GOG-NTX Emotional Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up).
- Functional Well-Being [11 weeks]
Change in the FACT/GOG-NTX Functional Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up).
- Impact on symptom experience [11 weeks]
Change in the ESAS scores from Baseline to T1 (last day of class) and T2 (1-week follow-up).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with cancer, stage 1-4.
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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.
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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).
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Age ≥ 18 years.
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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).
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Reasonable functional stability as assessed by the evaluating physician.
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Must be able to understand and communicate proficiently in English.
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Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
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Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician.
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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.
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Neuropathy related to abnormal TSH or B12 levels as assessed by treating physician
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Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician.
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Severe personality disorder or psychiatric disorder that would interfere with participation in a QiGong program, as assessed by the evaluating physician.
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Currently participating in another QiGong or Tai Chi program.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Arash Asher, MD
Investigators
- Principal Investigator: Arash Asher, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIT2019-07-ASHER-QIGONG