Clinical trial NCT00902031: Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Palliative Care
Keywords: Docusate
Constipation
Colace
Palliative Care
Sennoside
Senokot
Terminally Ill
Stool
Randomized Trial
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: College of Family Physicians of Canada
name: Covenant Health, Canada
name: Capital Care
First posted: 2009-05-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if docusate is effective in the treatment of constipation in palliative care patients.

Detailed description: Palliative patients frequently experience constipation due to multiple factors - structural abnormalities, medications, metabolic disturbances, neurological disorders, and other general conditions. Docusate is a stool softener that has been widely used, in combination with other stimulating laxatives, to prevent and treat constipation in palliative care patients. In the past decade there has been controversy about its effectiveness in these populations, but no controlled trials have been conducted on the use of docusate in palliative patients. The purpose of this study is to assess the effectiveness of docusate in preventing and treating constipation in palliative care patients. The study design is a randomized, double-blind, placebo-controlled trial to compare the current standard treatment (docusate in combination with a laxative, sennoside) to that of a sennoside laxative alone. A total of 70 patients (35 in each group) will be recruited from the Palliative Care Unit at St. Joseph's Auxiliary Care Hospital, the Mel Miller Hospice at the Edmonton General Continuing Care Hospital, and CapitalCare Norwood in Edmonton, Alberta, Canada. Patients must be ≥ 18 years of age, able to take oral medication, without difficulty swallowing, have a palliative performance ≥ 20%, and do not have a stoma. The duration of treatment will be for 10 days. The main outcome measures will include bowel frequency, stool consistency, other interventions (suppositories, enemas), difficulty defecating, and sense of inability to evacuate completely. This study will provide insight into the effectiveness of docusate in preventing and treating constipation in palliative patients who are cared for by family physicians and specialized palliative care providers. If docusate is found to have no added benefit,it has the potential to enhance the quality of life for palliative care patients by reducing the number of medications taken and reducing the palliative care team's (e.g. nursing) workload and cost.

Eligibility criteria: Inclusion Criteria:

* greater than or equal to 18 years of age
* new admissions
* able to take oral medications
* patient and/or personal directive agent (proxy) provides written consent
* does not have a stoma
* no difficulty swallowing
* no previous intolerance/contraindications to docusate
* palliative performance greater than or equal to 20%

Exclusion Criteria:

* less than 18 years of age
* failing to provide consent
* unable to take oral medication/difficulty swallowing
* previous intolerance/contraindications to docusate (Colace)
* patients who have a stoma
* palliative performance status \< 20%

Primary outcomes:
measure: Stool Frequency
timeFrame: 10 days
measure: Stool Consistency
timeFrame: 10 day
measure: Difficulty Defecating
timeFrame: 10 day
measure: Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath)
timeFrame: 10 day
measure: Type of Additional Bowel Care Interventions which may be Required
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: CapitalCare Norwood
state: Alberta
city: Edmonton
country: Canada
facility: Mel Miller Hospice at Edmonton General Continuing Care Hospital
state: Alberta
city: Edmonton
country: Canada
facility: St. Joseph's Auxiliary Care Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Richard Spooner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta/Regional Palliatvie Care Program (Capital Health)
name: Yoko Tarumi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Olga Szafran, MSc.
role: STUDY_DIRECTOR
References:
citation: CASS LJ, FREDERIK WS. Doxinate in the treatment of constipation. Am J Gastroenterol. 1956 Dec;26(6):691-8. No abstract available.
citation: Castle SC, Cantrell M, Israel DS, Samuelson MJ. Constipation prevention: empiric use of stool softeners questioned. Geriatrics. 1991 Nov;46(11):84-6. No abstract available.
citation: Fain AM, Susat R, Herring M, Dorton K. Treatment of constipation in geriatric and chronically ill patients: a comparison. South Med J. 1978 Jun;71(6):677-80. doi: 10.1097/00007611-197806000-00022.
citation: Goodman J, Pang J, Bessman AN. Dioctyl sodium sulfosuccinate- an ineffective prophylactic laxative. J Chronic Dis. 1976 Jan;29(1):59-63. doi: 10.1016/0021-9681(76)90068-0. No abstract available.
citation: Hurdon V, Viola R, Schroder C. How useful is docusate in patients at risk for constipation? A systematic review of the evidence in the chronically ill. J Pain Symptom Manage. 2000 Feb;19(2):130-6. doi: 10.1016/s0885-3924(99)00157-8.