Managing Medication-induced Constipation in Cancer: A Clinical Trial
Constipation
About this trial
This is an interventional supportive care trial for Constipation focused on measuring Medication-induced, Constipation in Cancer
Eligibility Criteria
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.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Other
Active Comparator
Other
Dose Intervention - Opioid
Assessment Intervention - Opioid
Control Group - Opioid
Assessment Intervention - Vinca Alkaloid
Control Group - Vinca Alkaloid
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.
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.
Standard of Care: Participants Receiving Opioids for the Treatment of Pain will receive their usual care at Moffitt while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.
Laxative Treatment: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. 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 their level of constipation.
Standard of Care: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Patients will receive standard of care while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.