Back to resultsA Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy (QiGong)
Primary Purpose
Chemotherapy-induced Peripheral Neuropathy, Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Qi Gong
Sponsored by
About this trial
This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Qi Gong
Eligibility Criteria
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.
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Qi Gong
Arm Description
Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks
Outcomes
Primary Outcome Measures
Objective Modified Total Neuropathy Scale (mTNS) score
Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class)
Subjective Neurotoxicity Subscale score
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
Number of QiGong classes attended by those who enroll
Retention
Completion of both pre- and post-assessments
Patient Interest
Percentage of patients approached who sign consent
Patient Evaluation of QiGong Program
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
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
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
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
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
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
Change in the ESAS scores from Baseline to T1 (last day of class) and T2 (1-week follow-up).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04185610
Brief Title
A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
Acronym
QiGong
Official Title
IIT2019-07-ASHER-QIGONG: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arash Asher, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Cancer
Keywords
Qi Gong
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qi Gong
Arm Type
Experimental
Arm Description
Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks
Intervention Type
Other
Intervention Name(s)
Qi Gong
Intervention Description
Guided Qi Gong class
Primary Outcome Measure Information:
Title
Objective Modified Total Neuropathy Scale (mTNS) score
Description
Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class)
Time Frame
10 weeks
Title
Subjective Neurotoxicity Subscale score
Description
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).
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Attendance
Description
Number of QiGong classes attended by those who enroll
Time Frame
10 weeks
Title
Retention
Description
Completion of both pre- and post-assessments
Time Frame
10 weeks
Title
Patient Interest
Description
Percentage of patients approached who sign consent
Time Frame
1 week
Title
Patient Evaluation of QiGong Program
Description
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.
Time Frame
1 day
Title
Perceived cognitive functioning
Description
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).
Time Frame
11 weeks
Title
Physical Well-Being
Description
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).
Time Frame
11 weeks
Title
Social/Family Well-Being
Description
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).
Time Frame
11 weeks
Title
Emotional Well-Being
Description
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).
Time Frame
11 weeks
Title
Functional Well-Being
Description
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).
Time Frame
11 weeks
Title
Impact on symptom experience
Description
Change in the ESAS scores from Baseline to T1 (last day of class) and T2 (1-week follow-up).
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Asher, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
We'll reach out to this number within 24 hrs