Chemotherapy-induced Peripheral NeuropathyQiGongNCT04185610
A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
A study testing Qi Gong in people with Chemotherapy-induced Peripheral Neuropathy and Cancer, run by Arash Asher, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Cancer
- What is being tested?
- Qi Gong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Cancer
- Being tested
- Qi Gong
- Keywords
- Qi Gong
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qi GongOther
Guided Qi Gong class
| Study group | Role | What they receive |
|---|---|---|
| Qi Gong | Experimental | Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks Receives: Other: Qi Gong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Modified Total Neuropathy Scale (mTNS) score
Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class)
Measured: 10 weeks
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).
Measured: 11 weeks
Secondary outcomes (10)
Attendance
Number of QiGong classes attended by those who enroll
Measured: 10 weeks
Retention
Completion of both pre- and post-assessments
Measured: 10 weeks
Patient Interest
Percentage of patients approached who sign consent
Measured: 1 week
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.
Measured: 1 day
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).
Measured: 11 weeks
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).
Measured: 11 weeks
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).
Measured: 11 weeks
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).
Measured: 11 weeks
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).
Measured: 11 weeks
Impact on symptom experience
Change in the ESAS scores from Baseline to T1 (last day of class) and T2 (1-week follow-up).
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start4 Dec 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arash Asher, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arash Asher, MD, Cedars-Sinai Medical Center
- Investigators
- Arash Asher, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185610
- Sponsor's protocol ID
- IIT2019-07-ASHER-QIGONG
- Acronym
- QiGong
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2019-07-ASHER-QIGONG: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04185610
- Acronym / sponsor ID
- QiGong / IIT2019-07-ASHER-QIGONG
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Cancer
- Keywords
- Qi Gong
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Arash Asher, MDUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qi Gong | Experimental | Other: Qi GongWeekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qi GongGuided Qi Gong class | Other | Qi Gong |
Primary outcome
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)
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).
10 secondary outcomes
Attendance
Time frame: 10 weeks
Retention
Time frame: 10 weeks
Patient Interest
Time frame: 1 week
Patient Evaluation of QiGong Program
Time frame: 1 day
Perceived cognitive functioning
Time frame: 11 weeks
Physical Well-Being
Time frame: 11 weeks
Social/Family Well-Being
Time frame: 11 weeks
Emotional Well-Being
Time frame: 11 weeks
Functional Well-Being
Time frame: 11 weeks
Impact on symptom experience
Time frame: 11 weeks
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Asher, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qi Gong in people with Chemotherapy-induced Peripheral Neuropathy and Cancer, run by Arash Asher, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Modified Total Neuropathy Scale (mTNS) score (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.