- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185610
A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy (QiGong)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Qi Gong
Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks
|
Guided Qi Gong class
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Modified Total Neuropathy Scale (mTNS) score
Time Frame: 10 weeks
|
Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class)
|
10 weeks
|
Subjective Neurotoxicity Subscale score
Time Frame: 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).
|
11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance
Time Frame: 10 weeks
|
Number of QiGong classes attended by those who enroll
|
10 weeks
|
Retention
Time Frame: 10 weeks
|
Completion of both pre- and post-assessments
|
10 weeks
|
Patient Interest
Time Frame: 1 week
|
Percentage of patients approached who sign consent
|
1 week
|
Patient Evaluation of QiGong Program
Time Frame: 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. |
1 day
|
Perceived cognitive functioning
Time Frame: 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).
|
11 weeks
|
Physical Well-Being
Time Frame: 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).
|
11 weeks
|
Social/Family Well-Being
Time Frame: 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).
|
11 weeks
|
Emotional Well-Being
Time Frame: 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).
|
11 weeks
|
Functional Well-Being
Time Frame: 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).
|
11 weeks
|
Impact on symptom experience
Time Frame: 11 weeks
|
Change in the ESAS scores from Baseline to T1 (last day of class) and T2 (1-week follow-up).
|
11 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2019-07-ASHER-QIGONG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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