A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy

NCT04185610 | Terminated DMC

• 1 other identifier: IIT2019-07-ASHER-QIGONG
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Cancer

Keywords

Qi Gong

Outcome Measures

Primary Outcomes (2)

• Objective Modified Total Neuropathy Scale (mTNS) score

  Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class)

  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).

  11 weeks

Secondary Outcomes (10)

• Attendance

  10 weeks

• Retention

  10 weeks

• Patient Interest

  1 week

• Patient Evaluation of QiGong Program

  1 day

• Perceived cognitive functioning

  11 weeks

Study Arms (1)

Qi Gong

EXPERIMENTAL

Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks

Other: Qi Gong

Interventions

Qi Gong OTHER

Guided Qi Gong class

Qi Gong

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arash Asher, MD: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Qigong

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Arash Asher, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cancer Rehabilitation & Survivorship

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: December 4, 2019
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

US (1)