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Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

Primary Purpose

Constipation, Advanced Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, Acupuncture, Laser acupuncture, Advanced Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

LA group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2020
Last Updated
March 8, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04318808
Brief Title
Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer
Official Title
Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer: a Prospective Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Advanced Cancer
Keywords
Constipation, Acupuncture, Laser acupuncture, Advanced Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LA group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laser acupuncture
Intervention Description
Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
Primary Outcome Measure Information:
Title
Complete spontaneous bowel movements (CSBM)
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Comfort levels during defecation
Description
Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).
Time Frame
1 week
Title
Symptoms of constipation
Description
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).
Time Frame
1 week
Title
Colonic motility
Description
Measured by auscultation of the lower right abdomen with a stethoscope.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Ting Liu, MD
Phone
+886-7-7317123
Ext
2334
Email
juntin0214@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Organizational Affiliation
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Phone
+886-7-7317123
Ext
2334
Email
juntin0214@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

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