Cancer, Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
Qi Gong
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.
Interventions
OTHERQi Gong
Guided Qi Gong class
Sponsors
Arash Asher, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Attendance | 10 weeks | Number of QiGong classes attended by those who enroll |
| 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). |
| 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). |
| Retention | 10 weeks | Completion of both pre- and post-assessments |
Countries
United States
Outcome results
None listed