Advanced Cancer, Constipation
Conditions
Keywords
Constipation, Acupuncture, Laser acupuncture, Advanced Cancer
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.
Interventions
PROCEDURELaser acupuncture
Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORChun-Ting Liu, MD
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
Outcome results
None listed