ConstipationNCT01416909
Managing Medication-induced Constipation in Cancer: A Clinical Trial
A study testing Laxative Treatment and Assessment Questionnaires in people with Constipation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Laxative Treatment and Assessment Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Laxative Treatment, Standard of Care, Assessment Questionnaires
- Keywords
- Medication-induced, Constipation in Cancer
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laxative TreatmentOther
Also called constipation 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.
Standard of CareOther
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.
Assessment QuestionnairesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Dose Intervention - Opioid | Active comparator | 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. Receives: Other: Laxative Treatment; Other: Assessment Questionnaires |
| Assessment Intervention - Opioid | Active comparator | 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. Receives: Other: Laxative Treatment; Other: Assessment Questionnaires |
| Control Group - Opioid | Other | 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. Receives: Other: Standard of Care; Other: Assessment Questionnaires |
| Assessment Intervention - Vinca Alkaloid | Active comparator | 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. Receives: Other: Laxative Treatment; Other: Assessment Questionnaires |
| Control Group - Vinca Alkaloid | Other | 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. Receives: Other: Standard of Care; Other: Assessment Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I - Record Constipation Incidence and Symptoms
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.
Measured: 18 months
Secondary outcomes (2)
Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation
To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.
Measured: 2 years, 3 months
Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation
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.
Measured: 2 years, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startNov 2008
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of South Florida
- Responsible party
- Sponsor
- Investigators
- Susan McMillan, Ph.D., RN, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416909
- Sponsor's protocol ID
- MCC-15712
- Status last verified
- Mar 2015
- First submitted
- 11 Aug 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Medication-induced Constipation in Cancer: A Clinical Trial
- ClinicalTrials.gov ID
- NCT01416909
- Acronym / sponsor ID
- MCC-15712
- Conditions
- Constipation
- Keywords
- Medication-induced, Constipation in Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of South Florida
- Study start
- Nov 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Intervention - Opioid | Active comparator | Other: Laxative Treatment, Other: Assessment QuestionnairesLaxative 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. |
| Assessment Intervention - Opioid | Active comparator | Other: Laxative Treatment, Other: Assessment QuestionnairesLaxative 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. |
| Control Group - Opioid | Other | Other: Standard of Care, Other: Assessment QuestionnairesStandard 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. |
| Assessment Intervention - Vinca Alkaloid | Active comparator | Other: Laxative Treatment, Other: Assessment QuestionnairesLaxative 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. |
| Control Group - Vinca Alkaloid | Other | Other: Standard of Care, Other: Assessment QuestionnairesStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laxative TreatmentAlso: constipation treatmentParticipants 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 | Assessment Intervention - Opioid, Assessment Intervention - Vinca Alkaloid, Dose Intervention - Opioid |
| Standard of CareParticipants 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 | Control Group - Opioid, Control Group - Vinca Alkaloid |
| Assessment QuestionnairesConstipation 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). | Other | Assessment Intervention - Opioid, Assessment Intervention - Vinca Alkaloid, Control Group - Opioid, Control Group - Vinca Alkaloid, Dose Intervention - Opioid |
Primary outcome
Phase I - Record Constipation Incidence and Symptoms
Time frame: 18 months
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.
2 secondary outcomes
Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation
Time frame: 2 years, 3 months
Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation
Time frame: 2 years, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan McMillan, Ph.D., RN principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laxative Treatment and Assessment Questionnaires in people with Constipation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I - Record Constipation Incidence and Symptoms (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.