Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04318808

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation Advanced Cancer	Procedure: Laser acupuncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

The participants in each group will receive real (with energy output) or sham (without energy output) laser acupuncture. The feelings of participants in each group are not different. The care provider and outcomes assessor don't involve the random allocation and don't know if participants receive real laser acupuncture.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LA group 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 Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
Sham Comparator: Control group 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 Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.

Arm

Intervention/Treatment

Experimental: LA group

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

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

Sham Comparator: Control group

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	833

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

Principal Investigator: Chun-Ting Liu, MD, Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT04318808

Other Study ID Numbers:

CMRPG8K0031

First Posted:

Mar 24, 2020

Last Update Posted:

Mar 10, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chang Gung Memorial Hospital

Additional relevant MeSH terms:

Neoplasms

Constipation

Study Results

No Results Posted as of Mar 10, 2022