Clinical trial NCT04185610: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
Official title: IIT2019-07-ASHER-QIGONG: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Cancer
Keywords: Qi Gong
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Objective Modified Total Neuropathy Scale (mTNS) score
timeFrame: 10 weeks
measure: Subjective Neurotoxicity Subscale score
timeFrame: 11 weeks
Secondary outcomes:
measure: Attendance
timeFrame: 10 weeks
measure: Retention
timeFrame: 10 weeks
measure: Patient Interest
timeFrame: 1 week
measure: Patient Evaluation of QiGong Program
timeFrame: 1 day
measure: Perceived cognitive functioning
timeFrame: 11 weeks
measure: Physical Well-Being
timeFrame: 11 weeks
measure: Social/Family Well-Being
timeFrame: 11 weeks
measure: Emotional Well-Being
timeFrame: 11 weeks
measure: Functional Well-Being
timeFrame: 11 weeks
measure: Impact on symptom experience
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, MD
role: PRINCIPAL_INVESTIGATOR
References: