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NCT04318808 Clinical Trial

Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04318808
Other study ID # CMRPG8K0031
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date August 2022

Study information
Verified date July 2021
Source Chang Gung Memorial Hospital
Contact Chun-Ting Liu, MD
Phone +886-7-7317123
Email juntin0214@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 74
Est. completion date August 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Laser acupuncture
Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Colonic motility Measured by auscultation of the lower right abdomen with a stethoscope. 1 week
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