Clinical trial · Interventional
Managing Medication-induced Constipation in Cancer: A Clinical Trial
NCT01416909CI-TRIAL-00026125completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research is to evaluate the effectiveness of the Constipation Treatment Protocol and to test whether management according to dose of constipation-inducing medications or according to on-going assessment is most effective.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Constipation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment Questionnaires | Other | — | UNRESOLVED |
| Laxative Treatment | Other | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- Dose Intervention - Opioid
- description
- Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on the dose of the opioid pain medication they are receiving.
- interventionNames
- Other: Laxative Treatment
- Other: Assessment Questionnaires
- type
- ACTIVE_COMPARATOR
- label
- Assessment Intervention - Opioid
- description
- Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be determined based on their severity of constipation.
- interventionNames
- Other: Laxative Treatment
- Other: Assessment Questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The study sample will consist of patients who are receiving outpatient care at the Moffitt Cancer Center. * Patients will be identified as those who have a diagnosis of cancer and are being treated with either opioids or vinca alkaloids, * are adults (or children 18-21 years old), * either male or female, * able to read and understand English, * and able to pass screening with the Short Portable Mental Status Questionnaire and Karnofsky Performance Status Scale. Exclusion Criteria: * Patients will be excluded: if they have non-melanoma skin cancer or colorectal or gynecological cancer as their primary diagnosis; * if they are excessively debilitated or deemed unlikely to survive for the eight weeks of the data collection period; * if they are unable to read and understand English; * if they have an ostomy that changes bowel function; * if they have a current peritoneal catheter; * if they have had abdominal surgery within the past six weeks; * or have a disease process suggestive of mechanical obstruction (tumor or adhesion); * if they have a history of chronic bowel disease (including irritable bowel syndrome, chronic constipation prior to cancer onset, Crohn's disease, ulcerative colitis or diarrhea as a result of radiation to the pelvis), or report chronic laxative use prior to cancer onset.
References
Publications (0)
Data not yet available
No reference posted for this study.