CancerNCT05764447
Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy
A study testing Combined qigong Baduanjin and self-administered acupressure in people with Cancer and Chemotherapy-induced Peripheral Neuropathy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Combined qigong Baduanjin and self-administered acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Mar 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Chemotherapy-induced Peripheral Neuropathy in Cancer Patients Using a Combined Qigong Baduanjin and Self-administered Acupressure Intervention: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cancer, Chemotherapy-induced Peripheral Neuropathy
- Being tested
- Combined qigong Baduanjin and self-administered acupressure, Wait-list Control
- Keywords
- cancer, neuropathy, acupressure, qigong, Baduanjin, chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined qigong Baduanjin and self-administered acupressureBehavioural
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.
Wait-list ControlBehavioural
The participants will receive usual care alone during the study period and will be offered the training after the last follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Combined Qigong Baduanjin and Self-administered Acupressure Intervention | Experimental | 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. Receives: Behavioral: Combined qigong Baduanjin and self-administered acupressure |
| Wait-list Control Group | Active comparator | 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. Receives: Behavioral: Wait-list Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (week 0) to post-intervention (week 16)
Secondary outcomes (6)
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.
Measured: Change from baseline to 12 weeks after the intervention ends (week 28)
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.
Measured: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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
Measured: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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.
Measured: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
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.
Measured: post-intervention (week 16), 12 weeks after the intervention ends (week 28)
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.
Measured: Change from baseline (week 0) to post-intervention (week 16), Change from baseline to 12 weeks after the intervention ends (week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start10 Mar 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Shuk-Ting, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764447
- Sponsor's protocol ID
- UW22587
- Status last verified
- May 2023
- First submitted
- 14 Feb 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request as decided by the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Chemotherapy-induced Peripheral Neuropathy in Cancer Patients Using a Combined Qigong Baduanjin and Self-administered Acupressure Intervention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05764447
- Acronym / sponsor ID
- UW22587
- Conditions
- Cancer, Chemotherapy-induced Peripheral Neuropathy
- Keywords
- cancer, neuropathy, acupressure, qigong, Baduanjin, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Qigong Baduanjin and Self-administered Acupressure Intervention | Experimental | Behavioral: Combined qigong Baduanjin and self-administered acupressureThe 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. |
| Wait-list Control Group | Active comparator | Behavioral: Wait-list ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined qigong Baduanjin and self-administered acupressureThe 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. | Behavioural | Combined Qigong Baduanjin and Self-administered Acupressure Intervention |
| Wait-list ControlThe participants will receive usual care alone during the study period and will be offered the training after the last follow-up. | Behavioural | Wait-list Control Group |
Primary outcome
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.
6 secondary outcomes
Change in self-reported CIPN severity at follow-up
Time frame: Change from baseline to 12 weeks after the intervention ends (week 28)
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)
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)
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)
Fall incidence
Time frame: post-intervention (week 16), 12 weeks after the intervention ends (week 28)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request as decided by the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined qigong Baduanjin and self-administered acupressure in people with Cancer and Chemotherapy-induced Peripheral Neuropathy, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported CIPN severity post-intervention (time frame: Change from baseline (week 0) to post-intervention (week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.