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Managing Medication-induced Constipation in Cancer: A Clinical Trial

NCT01416909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2017-02-23

No results posted yet for this study

Summary

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

Interventions

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

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).

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of South Florida

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Susan McMillan, Ph.D., RN · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2013-08-31
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416909 on ClinicalTrials.gov