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
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Constipation
• Neoplasms

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