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A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy (QiGong)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185610
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Arash Asher, MD, Cedars-Sinai Medical Center

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
Chemotherapy-induced Peripheral Neuropathy Cancer Other: Qi Gong Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: IIT2019-07-ASHER-QIGONG: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
Estimated Study Start Date : December 3, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Qi Gong
Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks
Other: Qi Gong
Guided Qi Gong class




Primary Outcome Measures :
  1. 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)

  2. 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).


Secondary Outcome Measures :
  1. Attendance [ Time Frame: 10 weeks ]
    Number of QiGong classes attended by those who enroll

  2. Retention [ Time Frame: 10 weeks ]
    Completion of both pre- and post-assessments

  3. Patient Interest [ Time Frame: 1 week ]
    Percentage of patients approached who sign consent

  4. 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.


  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with cancer, stage 1-4.
  • Completed taxane- or platinum-based chemotherapy at least three months (90 days) ago. 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 randomization).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185610


Contacts
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Contact: Bethy Woubeshet 424-315-2215 bethy.woubeshet@cshs.org
Contact: Laura Lockshon 424-315-2219 laura.lockshon@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Bethy Woubeshet    424-315-2215    Bethy.Woubeshet@cshs.org   
Principal Investigator: Arash Asher, MD         
Sponsors and Collaborators
Arash Asher, MD
Investigators
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Principal Investigator: Arash Asher, MD Cedars-Sinai Medical Center

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Responsible Party: Arash Asher, MD, Director, Cancer Rehabilitation & Survivorship, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04185610    
Other Study ID Numbers: IIT2019-07-ASHER-QIGONG
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arash Asher, MD, Cedars-Sinai Medical Center:
Qi Gong
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases