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Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy

Primary Purpose

Cancer, Chemotherapy-induced Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Combined qigong Baduanjin and self-administered acupressure
Wait-list Control
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer, neuropathy, acupressure, qigong, Baduanjin, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined Qigong Baduanjin and Self-administered Acupressure Intervention

Wait-list Control Group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change in self-reported CIPN severity post-intervention
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.

Secondary Outcome Measures

Change in self-reported CIPN severity at follow-up
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.
Objective CIPN severity
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.
Handgrip strength
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
Lower-extremity physical functioning
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.
Fall incidence
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.
Global health-related quality of life (HRQoL)
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.

Full Information

First Posted
February 14, 2023
Last Updated
May 8, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05764447
Brief Title
Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy
Official Title
Improving Chemotherapy-induced Peripheral Neuropathy in Cancer Patients Using a Combined Qigong Baduanjin and Self-administered Acupressure Intervention: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to investigate the effects of a 16-week combined qigong and acupressure intervention on reducing self-reported chemotherapy-induced peripheral neuropathy (CIPN) severity, objective measures of CIPN severity, lower-extremity functioning, handgrip strength, fall incidence, and health-related quality of life post-intervention among post-chemotherapy adult cancer patients. This will be a 2-arm assessor-blinded randomized controlled trial that will follow the CONSORT guidelines. A total of 104 cancer patients aged ≥18 who have completed neurotoxic chemotherapy at least 1 month prior to enrolment and experiencing CIPN will be recruited and randomized into combined qigong and self-administered acupressure intervention and wait-list control groups. The intervention group comprises of twice-weekly supervised group sessions and three times-weekly self-practice prescription (30 min each time) on days without group sessions. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Chemotherapy-induced Peripheral Neuropathy
Keywords
cancer, neuropathy, acupressure, qigong, Baduanjin, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
An independent randomizer will prepare a computer-generated list of random assignments in sealed, sequentially numbered opaque envelopes. To aid allocation concealment, permuted blocks of varying sizes with an allocation weight of 1:1 will be used. The randomizer will keep a secure copy of the randomization list, which will be concealed from all research personnel and participants. The statistician performing data analysis will be blinded. Although it is not feasible to blind the participants or intervention personnel to the group assignments, the outcome assessors will be blinded.
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined Qigong Baduanjin and Self-administered Acupressure Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Combined qigong Baduanjin and self-administered acupressure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait-list Control
Intervention Description
The participants will receive usual care alone during the study period and will be offered the training after the last follow-up.
Primary Outcome Measure Information:
Title
Change in self-reported CIPN severity post-intervention
Description
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.
Time Frame
Change from baseline (week 0) to post-intervention (week 16)
Secondary Outcome Measure Information:
Title
Change in self-reported CIPN severity at follow-up
Description
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.
Time Frame
Change from baseline to 12 weeks after the intervention ends (week 28)
Title
Objective CIPN severity
Description
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.
Time Frame
Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
Title
Handgrip strength
Description
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
Time Frame
Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
Title
Lower-extremity physical functioning
Description
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.
Time Frame
Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
Title
Fall incidence
Description
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.
Time Frame
post-intervention (week 16), 12 weeks after the intervention ends (week 28)
Title
Global health-related quality of life (HRQoL)
Description
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.
Time Frame
Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Shuk Ting Cheung, PhD
Phone
39176673
Email
denisest@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Sheung Yiu Chan, MNurs
Phone
39176966
Email
chansyc@hku.hk
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Shuk Ting Cheung, PhD
Phone
3917 6673
Email
denisest@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available on reasonable request as decided by the principal investigator.
IPD Sharing Time Frame
Data will be available for 3 years after the manuscript on main findings is published.

Learn more about this trial

Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy

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