NCT04318808

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 10, 2022

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

March 16, 2020

Last Update Submit

March 8, 2022

Conditions

ConstipationAdvanced Cancer

Keywords

ConstipationAcupunctureLaser acupunctureAdvanced Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Comfort levels during defecation

    1 week

  • Symptoms of constipation

    1 week

  • Colonic motility

    1 week

Study Arms (2)

LA group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

Laser acupuncturePROCEDURE

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

Control groupLA group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Intestinal obstruction
  • Disturbance of consciousness
  • Active gastrointestinal bleeding
  • Active intraabdominal infection
  • Local skin infection on the acupoints or limb amputees.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chun-Ting Liu, MD

    Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Ting Liu, MD

CONTACT

+886-7-7317123juntin0214@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 24, 2020

Study Start

March 1, 2020

Primary Completion

February 28, 2022

Study Completion

August 1, 2022

Last Updated

March 10, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)