Managing Medication-induced Constipation in Cancer: A Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of South Florida
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01416909
First received: August 11, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Constipation
Other: Laxative Treatment
Other: Standard of Care
Other: Assessment Questionnaires
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Managing Medication-induced Constipation in Cancer: A Clinical Trial

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Phase I - Record Constipation Incidence and Symptoms [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    To identify the incidence, severity, distress and trajectory of constipation in cancer patients receiving opioids over an eight week period and to evaluate the relationships between constipation intensity and opioid dose.

    To identify the incidence, severity, distress and trajectory of constipation in groups of cancer patients who may be at risk due to vinca alkaloids (vincristine. vinblastine. vinorelbine and vindesine) over an eight week period and to evaluate the relationship between constipation intensity and vinca alkaloid dose.



Secondary Outcome Measures:
  • Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation [ Time Frame: 2 years, 3 months ] [ Designated as safety issue: No ]
    To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.

  • Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation [ Time Frame: 2 years, 3 months ] [ Designated as safety issue: No ]

    To test whether laxative dose is best determined based on on-going assessment or on opioid dose.

    To test whether laxative dose is best determined based on on-going assessment or on vinca alkaloid dose.



Enrollment: 601
Study Start Date: November 2008
Estimated Study Completion Date: April 2015
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose Intervention - Opioid
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.
Other: Laxative Treatment
Participants will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol.
Other Name: constipation treatment
Other: Assessment Questionnaires
Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).
Active Comparator: Assessment Intervention - Opioid
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.
Other: Laxative Treatment
Participants will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol.
Other Name: constipation treatment
Other: Assessment Questionnaires
Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).
Control Group - Opioid
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.
Other: Standard of Care
Participants 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.
Other: Assessment Questionnaires
Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).
Active Comparator: Assessment Intervention - Vinca Alkaloid
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.
Other: Laxative Treatment
Participants will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol.
Other Name: constipation treatment
Other: Assessment Questionnaires
Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).
Control Group - Vinca Alkaloid
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.
Other: Standard of Care
Participants 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.
Other: Assessment Questionnaires
Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).

Detailed Description:

Patients will undergo a baseline assessment during their regular outpatient visit. With their permission, the investigators will audio record this visit for quality control. After the study, the recordings will be erased. Patients will be asked to complete 4 questionnaires. The investigators will collect contact information so that the follow-up assessments can be done by phone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416909

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
University of South Florida
Investigators
Principal Investigator: Susan McMillan, Ph.D., RN University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01416909     History of Changes
Other Study ID Numbers: MCC-15712
Study First Received: August 11, 2011
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Medication-induced
Constipation in Cancer

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Laxatives
Cathartics
Vinca Alkaloids
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014