Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients

University of Alberta

Status: Completed

Conditions: Constipation; Palliative Care

Treatments: Drug: Sennoside + Placebo; Drug: Docusate Sodium, Sennoside

Study type: Interventional

Funder types: Other

Identifiers

NCT00902031

G599001036

G517000014

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Docusate + Sennoside

Experimental group

Treatment:

Drug: Docusate Sodium, Sennoside

Sennoside + Placebo

Placebo Comparator group

Treatment:

Drug: Sennoside + Placebo