Hand-Foot SyndromeNCT05949307
The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
A study testing acupuncture and laser acupuncture in people with Hand-Foot Syndrome, run by China Medical University Hospital.
Trial summary
Chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. At present, there is no better treatment for this side effect of chemotherapy or target therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hand-Foot Syndrome
- What is being tested?
- acupuncture and laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 29 Mar 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients receiving chemotherapy or targeted therapy
- Age over 20 years old
- Western medicine diagnoses hand-foot syndrome
- Sign the consent form
Who cannot join
- Pregnant or planning to become pregnant
- Serious arrhythmia (or cardiac pacemaker installed)
- Epilepsy
- Severe organ failure, such as heart and lung failure, liver and kidney failure
- Psychiatric history, unable to cooperate with acupuncture and assessors
- Those who received traditional Chinese medicine treatment for hand-foot skin reaction
About this study
Chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. At present, there is no better treatment for this side effect of chemotherapy or target therapy. In severe cases, it is necessary to reduce the dose of chemotherapy or target therapy, which may affect the progress and effect of chemotherapy. In recent years, acupuncture has been widely used for many side effects of chemotherapy, such as numbness of hands and feet, gastrointestinal discomfort, and dizziness. There have been many studies have proved to be effective, but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients. Therefore, the investigators expect to evaluate the efficacy of acupuncture, and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future.
Read the detailed description
The investigators design a single-center, sham-controlled, assessor- and subject- blind, randomized clinical trial. 60 subjects will be equally and randomly divided into an acupuncture group, laser acupuncture, and sham-laser acupuncture groups in the 6-week trial. Each subject receives acupuncture, laser acupuncture, or sham-laser acupuncture three times a week for three consecutive weeks depending on their group, with a total of 9 times interventions. Outcome measures include Common adverse events evaluation standard version 5.0 (CTCAE) and Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI) and assessment of cancer patients' quality of life questionnaire (EORTC QLQ-C30). ANSWatch and Thermal Image Camera are also used to assess those subjects. Those outcome measures will be conducted at baseline, the 3rd and the 6th week after the interventions.
- Conditions
- Hand-Foot Syndrome
- Being tested
- acupuncture, laser acupuncture, Sham-laser acupuncture
- Keywords
- acupuncture, laser acupuncture, chemotherapy, target therapy, hand-foot syndrome
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
acupuncture
laser acupunctureDevice
laser acupuncture
Sham-laser acupunctureDevice
Sham-laser acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | receive acupuncture treatment Receives: Device: acupuncture |
| Laser acupuncture group | Experimental | receive laser acupuncture treatment Receives: Device: laser acupuncture |
| Sham laser acupuncture group | Sham comparator | receive sham-laser acupuncture treatment Receives: Device: Sham-laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
Evaluate skin symptoms assessed by Common Terminology Criteria for Adverse Events version 5. 0 (total three grade. Grade 1 is minimal skin changes, and grade 3 is severe skin changes)
Measured: Change from Baseline severity of hand-foot syndrome at 3 weeks
The change of scores of Visual analogue scale (VAS)
pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)
Measured: Change from Baseline severity of pain at 3 weeks
The change of Dermatology Life Quality Index (questionnaire)
evaluate quality of life assessed by Dermatology Life Quality Index
Measured: Change from Baseline quality of life at 3 weeks
The change of EORTC QLQ-C30 (questionnaire)
evaluate quality of life assessed by EORTC QLQ-C30
Measured: Change from Baseline quality of life at 3 weeks
The change of LF/HF before and after treatment
testing LF/HF assessed by ANSWatch wrist monitor
Measured: Change from Baseline LF/HF at 3 weeks
The change of temperature of limbs before and after treatment
testing temperature assessed by Thermal Imaging Analysis
Measured: Change from Baseline temperature at 3 weeks
Secondary outcomes (6)
The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
Evaluate skin symptoms assessed by Common Terminology Criteria for Adverse Events version 5. 0 (total three grade. Grade 1 is minimal skin changes, and grade 3 is severe skin changes)
Measured: Change from Baseline severity of hand-foot syndrome at 6 weeks
The change of scores of Visual analogue scale (VAS)
pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)
Measured: Change from Baseline severity of pain at 6 weeks
The change of Dermatology Life Quality Index (questionnaire)
evaluate quality of life assessed by Dermatology Life Quality Index
Measured: Change from Baseline quality of life at 6 weeks
The change of EORTC QLQ-C30 (questionnaire)
evaluate quality of life assessed by EORTC QLQ-C30
Measured: Change from Baseline quality of life at 6 weeks
The change of LF/HF before and after treatment
testing LF/HF assessed by ANSWatch wrist monitorng LF/HF
Measured: Change from Baseline LF/HF at 6 weeks
The change of temperature of limbs before and after treatment
testing temperature assessed by Thermal Imaging Analysis
Measured: Change from Baseline temperature at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion29 Mar 2024 (estimated)
- Study completion29 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand-Foot SyndromeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949307
- Sponsor's protocol ID
- CMUH112-REC1-020
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
- ClinicalTrials.gov ID
- NCT05949307
- Acronym / sponsor ID
- CMUH112-REC1-020
- Conditions
- Hand-Foot Syndrome
- Keywords
- acupuncture, laser acupuncture, chemotherapy, target therapy, hand-foot syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 29 Mar 2024 (estimated)
- First posted
- 18 Jul 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.
Chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. At present, there is no better treatment for this side effect of chemotherapy or target therapy. In severe cases, it is necessary to reduce the dose of chemotherapy or target therapy, which may affect the progress and effect of chemotherapy. In recent years, acupuncture has been widely used for many side effects of chemotherapy, such as numbness of hands and feet, gastrointestinal discomfort, and dizziness. There have been many studies have proved to be effective, but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients. Therefore, the investigators expect to evaluate the efficacy of acupuncture, and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future.
Detailed description
The investigators design a single-center, sham-controlled, assessor- and subject- blind, randomized clinical trial. 60 subjects will be equally and randomly divided into an acupuncture group, laser acupuncture, and sham-laser acupuncture groups in the 6-week trial. Each subject receives acupuncture, laser acupuncture, or sham-laser acupuncture three times a week for three consecutive weeks depending on their group, with a total of 9 times interventions. Outcome measures include Common adverse events evaluation standard version 5.0 (CTCAE) and Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI) and assessment of cancer patients' quality of life questionnaire (EORTC QLQ-C30). ANSWatch and Thermal Image Camera are also used to assess those subjects. Those outcome measures will be conducted at baseline, the 3rd and the 6th week after the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: acupuncturereceive acupuncture treatment |
| Laser acupuncture group | Experimental | Device: laser acupuncturereceive laser acupuncture treatment |
| Sham laser acupuncture group | Sham comparator | Device: Sham-laser acupuncturereceive sham-laser acupuncture treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients receiving chemotherapy or targeted therapy
- Age over 20 years old
- Western medicine diagnoses hand-foot syndrome
- Sign the consent form
Key exclusion criteria (6 listed)
- Pregnant or planning to become pregnant
- Serious arrhythmia (or cardiac pacemaker installed)
- Epilepsy
- Severe organ failure, such as heart and lung failure, liver and kidney failure
- Psychiatric history, unable to cooperate with acupuncture and assessors
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 |
|---|---|---|
| acupunctureacupuncture | Device | Acupuncture group |
| laser acupuncturelaser acupuncture | Device | Laser acupuncture group |
| Sham-laser acupunctureSham-laser acupuncture | Device | Sham laser acupuncture group |
Primary outcome
The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
Time frame: Change from Baseline severity of hand-foot syndrome at 3 weeks
Evaluate skin symptoms assessed by Common Terminology Criteria for Adverse Events version 5. 0 (total three grade. Grade 1 is minimal skin changes, and grade 3 is severe skin changes)
The change of scores of Visual analogue scale (VAS)
Time frame: Change from Baseline severity of pain at 3 weeks
pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)
The change of Dermatology Life Quality Index (questionnaire)
Time frame: Change from Baseline quality of life at 3 weeks
evaluate quality of life assessed by Dermatology Life Quality Index
The change of EORTC QLQ-C30 (questionnaire)
Time frame: Change from Baseline quality of life at 3 weeks
evaluate quality of life assessed by EORTC QLQ-C30
The change of LF/HF before and after treatment
Time frame: Change from Baseline LF/HF at 3 weeks
testing LF/HF assessed by ANSWatch wrist monitor
The change of temperature of limbs before and after treatment
Time frame: Change from Baseline temperature at 3 weeks
testing temperature assessed by Thermal Imaging Analysis
6 secondary outcomes
The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
Time frame: Change from Baseline severity of hand-foot syndrome at 6 weeks
The change of scores of Visual analogue scale (VAS)
Time frame: Change from Baseline severity of pain at 6 weeks
The change of Dermatology Life Quality Index (questionnaire)
Time frame: Change from Baseline quality of life at 6 weeks
The change of EORTC QLQ-C30 (questionnaire)
Time frame: Change from Baseline quality of life at 6 weeks
The change of LF/HF before and after treatment
Time frame: Change from Baseline LF/HF at 6 weeks
The change of temperature of limbs before and after treatment
Time frame: Change from Baseline temperature at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Hand-Foot Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
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SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
Not yet recruiting
Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
HFS
Not yet recruitingPhase 2
TAR-0520 Gel in Hand and Foot Syndrome
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Active, not recruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
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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.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and laser acupuncture in people with Hand-Foot Syndrome, run by China Medical University Hospital.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0 (time frame: Change from Baseline severity of hand-foot syndrome at 3 weeks). The study lists 6 primary outcomes in all. 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 18 Jul 2023.