ConstipationNCT04318808
Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer
A study testing Laser acupuncture in people with Constipation and Advanced Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Constipation is one of the most common complications in patients with advanced cancer. The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy on constipation in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Constipation, Advanced Cancer
- What is being tested?
- Laser acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Mar 2020to 30 Aug 2022
- 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
- Aged 20 years or older
- Principal diagnosis of advanced cancer
- Diagnosis of constipation
- Treat with laxatives for at least 1 week but still have symptoms of constipation
Who cannot join
- Intestinal obstruction
- Disturbance of consciousness
- Active gastrointestinal bleeding
- Active intraabdominal infection
- Local skin infection on the acupoints or limb amputees.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer: a Prospective Double-blind Randomized Controlled Trial
Constipation is one of the most common complications in patients with advanced cancer.
The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy on constipation in patients with advanced cancer.
- Conditions
- Constipation, Advanced Cancer
- Being tested
- Laser acupuncture
- Keywords
- Constipation, Acupuncture, Laser acupuncture, Advanced Cancer
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureProcedure or surgery
Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
| Study group | Role | What they receive |
|---|---|---|
| LA group | Experimental | The subjects in the experimental group will receive 0.375 J of energy at each of the following acupoints: LI4 (Hegu, B3), LI11 (Quchi, B2), PC6 (Neiguan, B3), ST36 (Zusanli, B2), ST37 (Shangjuxu, B2), ST39 (Xiajuxu, B2), SP4 (Gongsun, B3) , SP9 (Yinlingquan, B2). Receives: Procedure: Laser acupuncture |
| Control group | Sham comparator | The subjects in the control group will receive sham LA treatment, without any laser output (no stimulation) at the same acupoints used in experimental group. Receives: Procedure: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete spontaneous bowel movements (CSBM)
CSBM is defined as an spontaneous bowel movements associated with a sensation of complete evacuation. The number of CSBM within one week will be recorded.
Measured: 1 week
Secondary outcomes (3)
Comfort levels during defecation
Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).
Measured: 1 week
Symptoms of constipation
A five-symptoms questionnaire for measuring the severity of constipation including straining during defecation, abdominal pain during defecation, hard stools, sensation of incomplete evacuation, and sensation of anorectal obstruction or blockage. Each item is rated on a four point Likert scale that ranges from severe symptom (4 points) to no symptom (1 point).
Measured: 1 week
Colonic motility
Measured by auscultation of the lower right abdomen with a stethoscope.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start30 Mar 2020
- Primary completion28 Feb 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Ting Liu, MD, Principal investigator, Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318808
- Sponsor's protocol ID
- CMRPG8K0031
- Status last verified
- Jul 2021
- First submitted
- 16 Mar 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer: a Prospective Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04318808
- Acronym / sponsor ID
- CMRPG8K0031
- Conditions
- Constipation, Advanced Cancer
- Keywords
- Constipation, Acupuncture, Laser acupuncture, Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 24 Mar 2020 (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.
Constipation is one of the most common complications in patients with advanced cancer.
The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy on constipation in patients with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA group | Experimental | Procedure: Laser acupunctureThe subjects in the experimental group will receive 0.375 J of energy at each of the following acupoints: LI4 (Hegu, B3), LI11 (Quchi, B2), PC6 (Neiguan, B3), ST36 (Zusanli, B2), ST37 (Shangjuxu, B2), ST39 (Xiajuxu, B2), SP4 (Gongsun, B3) , SP9 (Yinlingquan, B2). |
| Control group | Sham comparator | Procedure: Laser acupunctureThe subjects in the control group will receive sham LA treatment, without any laser output (no stimulation) at the same acupoints used in experimental group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20 years or older
- Principal diagnosis of advanced cancer
- Diagnosis of constipation
- Treat with laxatives for at least 1 week but still have symptoms of constipation
Key exclusion criteria (5 listed)
- Intestinal obstruction
- Disturbance of consciousness
- Active gastrointestinal bleeding
- Active intraabdominal infection
- Local skin infection on the acupoints or limb amputees.
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 |
|---|---|---|
| Laser acupunctureLaser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation. | Procedure or surgery | Control group, LA group |
Primary outcome
Complete spontaneous bowel movements (CSBM)
Time frame: 1 week
CSBM is defined as an spontaneous bowel movements associated with a sensation of complete evacuation. The number of CSBM within one week will be recorded.
3 secondary outcomes
Comfort levels during defecation
Time frame: 1 week
Symptoms of constipation
Time frame: 1 week
Colonic motility
Time frame: 1 week
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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Irritable Bowel Syndrome, Constipation
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
Chun-Ting Liu, MD principal investigator
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture in people with Constipation and Advanced Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 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 20 Aug 2026. 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 Taiwan. 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. 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?
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?
Complete spontaneous bowel movements (CSBM) (time frame: 1 week). 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 20 Aug 2026.