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Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT04318808
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Constipation Advanced Cancer Procedure: Laser acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Complete spontaneous bowel movements (CSBM) [ Time Frame: 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 :
  1. Comfort levels during defecation [ Time Frame: 1 week ]
    Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).

  2. Symptoms of constipation [ Time Frame: 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).

  3. Colonic motility [ Time Frame: 1 week ]
    Measured by auscultation of the lower right abdomen with a stethoscope.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318808


Contacts
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Contact: Chun-Ting Liu, MD +886-7-7317123 ext 2334 juntin0214@gmail.com

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Chun-Ting Liu, MD    +886-7-7317123 ext 2334    juntin0214@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chun-Ting Liu, MD Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04318808    
Other Study ID Numbers: CMRPG8K0031
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Constipation
Acupuncture
Laser acupuncture
Advanced Cancer
Additional relevant MeSH terms:
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Constipation
Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms