Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

Not Applicable

• Conditions: Constipation; Advanced Cancer
• Interventions: Procedure: Laser acupuncture

• Registration Number: NCT04318808
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-22
• Study First Posted: 2020-03-24
• Status Verified: 2021-07
• Primary Completion: 2022-02-28
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LA group	Laser acupuncture	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).
Control group	Laser acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Complete spontaneous bowel movements (CSBM)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan