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

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

Detailed Description
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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.

Official Title
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Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients.

Conditions
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Constipation, Palliative Care

Intervention / Treatment
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* Drug: Docusate Sodium, Sennoside
* Drug: Sennoside + Placebo


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docusate + Sennoside<br> | Drug: Docusate Sodium, Sennoside<br>* Docusate sodium: given in capsule form (100 mg/capsule), at a dosage of 200 mg, taken twice daily for 10 days. Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days.<br>* Other names: Senokot;|
| Placebo Comparator: Sennoside + Placebo<br> | Drug: Sennoside + Placebo<br>* Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days. Placebo: will be taken in capsule form, similar in size, shape, and color to docusate, taken twice daily for 10 days<br>* Other names: Senokot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Frequency |  | 10 days | 
| Stool Consistency |  | 10 day | 
| Difficulty Defecating |  | 10 day | 
| Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath) |  | 10 day | 
| Type of Additional Bowel Care Interventions which may be Required |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Docusate, Constipation, Colace, Palliative Care, Sennoside, Senokot, Terminally Ill, Stool, Randomized Trial