Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer: a Prospective Double-blind Randomized Controlled Trial

Conditions
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Constipation, Advanced Cancer

Intervention / Treatment
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* Procedure: Laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Intestinal obstruction Disturbance of consciousness Active gastrointestinal bleeding Active intraabdominal infection Local skin infection on the acupoints or limb amputees.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LA group<br>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). | Procedure: Laser acupuncture<br>* Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.<br>|
| Sham Comparator: Control group<br>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. | Procedure: Laser acupuncture<br>* Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort levels during defecation | Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort). | 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). | 1 week | 
| Colonic motility | Measured by auscultation of the lower right abdomen with a stethoscope. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Acupuncture, Laser acupuncture, Advanced Cancer