- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764447
Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy
Improving Chemotherapy-induced Peripheral Neuropathy in Cancer Patients Using a Combined Qigong Baduanjin and Self-administered Acupressure Intervention: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of chemotherapy experiencing by cancer patients. CIPN can lead to significant distress, diminished health-related quality of life, functional decline, and an increased risk of falls in cancer patients, as they may experience altered proprioception. CIPN may continue to progress for several months post-treatment or even persist for years following chemotherapy.
Current pharmacological approaches are limited not only by side effects (e.g., fatigue, dizziness, insomnia, or nausea) but also by patients' unwillingness to further medicate a drug-related side effect. Also, the drugs may treat pain but not non-painful CIPN symptoms, and cannot induce neuro-protection or neuro-regeneration. Non-pharmacological interventions may be more appealing to patients, as they usually have no side effects and may result in clinical benefits for CIPN sufferers.
Acupressure is a non-invasive variant of acupuncture both adopting the meridian theory of traditional Chinese medicine (TCM) that stimulate acupoints across meridians and facilitate the flow of qi (energy) and blood, thereby restoring health and treating disease. Qigong is a mind-body exercise also rooted in the meridian theory of TCM. Through a combination of movement, breath control, and meditation, meridians can be opened, and the flow of qi and blood stimulated, to restore health. The combination approach is likely to elicit complementary physiologic adaptations on mechanisms involving both the peripheral and central nervous systems, thereby inducing a larger and potentially clinically meaningful improvement on CIPN.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Denise Shuk Ting Cheung, PhD
- Phone Number: 39176673
- Email: denisest@hku.hk
Study Contact Backup
- Name: Sheung Yiu Chan, MNurs
- Phone Number: 39176966
- Email: chansyc@hku.hk
Study Locations
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-
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Hong Kong, Hong Kong, 000000
- Recruiting
- Queen Mary Hospital
-
Contact:
- Denise Shuk Ting Cheung, PhD
- Phone Number: 3917 6673
- Email: denisest@hku.hk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥18 years
- diagnosis of cancer
- completed neurotoxic chemotherapy at least 1 month prior to enrolment
- experiencing CIPN (defined as tingling, numbness, or pain in the extremities in the past week, on the basis of a score ≥4 on an 11-point numerical rating scale due to receiving neurotoxic chemotherapy)
- Eastern Cooperative Oncology Group performance status between 0 and 2
- able to communicate in Cantonese or Mandarin
Exclusion Criteria:
- they have psychiatric disorders or conditions that preclude practicing qigong or acupressure (e.g., recent myocardial infarction, breathing difficulties requiring oxygen use or hospitalization, cannot walk independently)
- have regularly engaged in qigong or acupressure (>once per week) in the previous 6 months
- are receiving acupuncture
- are pregnant or lactating
- have any infection/injury/ulcers around the acupoints, or had peripheral neuropathy before chemotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combined Qigong Baduanjin and Self-administered Acupressure Intervention
The intervention will last 16 weeks, including twice-weekly supervised group sessions.
The first 8 weeks will focus on training of qigong Baduanjin and self-administered acupressure.
The duration of each group session will be 90 min.
From week 9 onwards, the group sessions will be shortened to 60 min twice a week led by the BQ master.
For self-practice prescription, participants will be instructed to practice the combined BQ and acupressure intervention three times a week (30 min each time) on the days without group sessions.
|
The intervention will combine Baduanjin (BQ) and acupressure.
The general design of the combination intervention is for BQ to be performed first (20 min), followed by self-administered acupressure (10 min).
BQ comprises eight simple standardized movements.
The combination of these simple body movements, breath control, and mindful meditation is designed to improve qi function.The acupressure protocol comprises six acupoints, i.e., Hegu, Quchi, Zusanli, Sanyinjiao, Qihai, and Taichong, which are the most commonly used acupoints in acupuncture trials for relieving CIPN according to previous reviews.
These acupoints, based on TCM theory, are beneficial for strengthening the origin of qi and directing its flow to the upper and lower extremities.
A massage pen will be used to stimulate the acupoints because participants with CIPN may have difficulty applying pressure with their hands/fingers.
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Active Comparator: Wait-list Control Group
The control group will be offered a free modality of their choice after the last follow-up.
The participants will receive usual care alone during the study period.
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The participants will receive usual care alone during the study period and will be offered the training after the last follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported CIPN severity post-intervention
Time Frame: Change from baseline (week 0) to post-intervention (week 16)
|
The 11-item version of Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG Ntx) subscale will be used.
It covers four domains: sensory, motor, hearing, and dysfunction.
Items are rated on a scale of 0 (not at all) to 4 (very much), with higher scores indicating more severe CIPN.
The Chinese version of FACT/GOG-Ntx has demonstrated satisfactory reliability and validity.
|
Change from baseline (week 0) to post-intervention (week 16)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported CIPN severity at follow-up
Time Frame: Change from baseline to 12 weeks after the intervention ends (week 28)
|
The 11-item version of Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG Ntx) subscale will be used.
It covers four domains: sensory, motor, hearing, and dysfunction.
Items are rated on a scale of 0 (not at all) to 4 (very much), with higher scores indicating more severe CIPN.
The Chinese version of FACT/GOG-Ntx has demonstrated satisfactory reliability and validity.
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Change from baseline to 12 weeks after the intervention ends (week 28)
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Objective CIPN severity
Time Frame: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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The sensory nerve action potential amplitude (SNAP) and sensory nerve conduction velocity (SNCV) will be measured to reflect the objective CIPN severity using Mediracer Device, a hand-held device comprising stimulation electrodes, cables and analysis software.
It has been validated for assessing carpel tunnel syndrome and used to quantify CIPN severity.
The electrodes are attached to the wrist and the base of index finger.
This device causes minimal discomfort to patients and can be used by trained research assistants.
The lower SNAP and SNCV, the more severe CIPN.
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Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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Handgrip strength
Time Frame: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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Handgrip strength will be measured by a dynamometer.
The maximum reading of two trials in standing position with full elbow extension using the dominant hand will be taken
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Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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Lower-extremity physical functioning
Time Frame: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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The Short Physical Performance Battery (SPPB) is an objective assessment tool used to measure lower-extremity physical functioning and is highly predictive of fall risk (44).
It consists of 3 functional tasks which can be completed within 10 minutes.
A summary score ranges from 0 to 12, with a higher score indicating a higher level of physical functioning.
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Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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Fall incidence
Time Frame: post-intervention (week 16), 12 weeks after the intervention ends (week 28)
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Fall incidence will be assessed by patient self-reports.
A fall is defined as unintentionally coming to rest on the ground or at some other lower level.
Participants indicating a fall will be asked about any resultant injury (e.g., sprains, fractures, head injuries) and the need to seek medical care.
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post-intervention (week 16), 12 weeks after the intervention ends (week 28)
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Global health-related quality of life (HRQoL)
Time Frame: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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Global HRQoL will be measured using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G).
It consists of 4 subscales: physical, emotional, social/family, and functional well-being.
Each item is rated from 0 ("not at all") to 4 ("very much").
Higher score represent better HRQoL.
FACT-G has been validated in Chinese populations with good reliability.
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Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW22587
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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