ConstipationNCT00032682
Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics
An observational study of Constipation and Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will evaluate a questionnaire for measuring constipation in children with cancer. The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the presence and severity of constipation in adult patients, but has not been tested in children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Constipation, Neoplasms
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Apr 2006
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NCI patients less than or equal to 21 years of age
- Diagnosis of histologically confirmed cancer
- Receiving: weekly vinca alkaloids and/or narcotics greater than or equal to 2 times per day (includes patient controlled analgesia, transdermal analgesic patches)
- ECOG performance score of less than or equal to 2
- Patients, parents, or legal guardian must be able to speak and read English
- Informed consent: All patients or their legal guardians (if patient is less than 18 years of age) must sign a document of informed consent indicating their understanding of the purpose of this study and the risks associated with participation. Pediatric patients less than 18 years of age will be included in all discussions. Written assent will be obtained in children less than 18 and greater than or equal to 8 years of age. Verbal assent will be obtained in children less than 8 years of age when possible.
Who cannot join
- Unable to provide consent/assent
- Patients with acute life threatening infection or bowel obstruction
- Patients with inevaluable bowel function (i.e. patients with a colostomy or paralyzed patients)
- Patients previously enrolled on this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study Evaluating the Assessment Process for Constipation in Pediatric Oncology Patients Who Are Receiving Vinca Alkaloids and/or Narcotics
This study will evaluate a questionnaire for measuring constipation in children with cancer. The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the presence and severity of constipation in adult patients, but has not been tested in children. The answers to the questionnaire will be used to determine the child's level of constipation and to plan and provide appropriate care.
Patients up to 21 years of age who are enrolled in National Cancer Institute trials and are taking weekly vinca alkaloids or narcotics twice a day or more may be eligible for this study.
Read more
On admission to the study, participants will undergo the following procedures:
- The child (or the child's parent) will be interviewed about the child's bowel habits.
- The results of the child's most recent physical examination related to bowel function will be obtained from the medical record for review.
- A registered dietitian will interview the child or parent about the child's eating habits.
During the study, participants will undergo the following procedures:
- A registered nurse will interview the child or parent about the child's bowel movements. This will be done every other day for hospitalized children and three times a week (by phone) for outpatients.
- The child or parent will complete a daily diary of bowel movements.
- A registered dietitian will evaluate the child's nutritional status periodically (by phone).
Children who are not constipated when they enter the study will receive a stool softener every day to prevent constipation. Children who become constipated during the study will be treated as needed. Patients will be followed for 7 days after the last dose of vinca alkaloid or narcotic for a maximum of 6 weeks.
Read the detailed description
Children with cancer are treated with complex therapies including chemotherapy, radiation, surgical interventions and biotherapy. Treatment with vinca alkaloids and/or narcotics combined with significant lifestyle changes secondary to the disease process can have a negative impact on the child's bowel elimination status. In trying to preserve the child's health and well being, constipation can be minimized or even prevented as an unwanted side effect of the treatments or disease condition.
Despite the widespread knowledge that constipation is prevalent in oncology patients, evidence shows that cancer treatment plans often overlook constipation and reflect the lack of consensus for effective assessment, treatment, and management. The research literature provides a database for addressing particular aspects of constipation. However, few studies address all the factors that affect bowel function and fewer still have recruited pediatric populations.
The Constipation Assessment Scale (CAS) is a valid and reliable measure found to be predictive of the presence and severity of constipation in the adult population, however it has never been tested in the pediatric population. A pilot study utilizing the CAS tool in children diagnosed with cancer will be conducted. The process for evaluating the presence and severity of constipation and the reliability and validity of the CAS tool will be tested. The study population will consist of inpatients and outpatients less than or equal to 21 years old, receiving weekly vinca alkaloids and/or narcotics greater than or equal to 2 times per day for pain management. Patients will be followed for 7 days after the last dose of vinca alkaloid and/or narcotic for a maximum of 6 weeks. Patients will be assessed on admission for bowel function and constipation. The admission assessment will include a nursing and nutrition assessment, review of the history and physical, and the administration of the CAS. Subsequent assessments include nursing, nutrition, administration of the CAS, and a patient daily bowel diary.
All patients regardless of participation in the study will be prescribed interventions based on the bowel prophylaxis and management guidelines established by the NCI POB staff. These guidelines were generated from validated studies, using Medline's criteria for scientific soundness and clinical relevance, in the oncology literature as well as from the experience of the NCI POB staff.
- Conditions
- Constipation, Neoplasms
- Keywords
- Bowel Movement, Children, Stool, Symptom Management, Cancer, Constipation
- Medical subject headings
- Constipation, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2002 (estimated)
- Study startMar 2002
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- 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
- Observational
- Enrolment
- 34 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032682
- Sponsor's protocol ID
- 020146
- Other IDs
- 02-CC-0146
- Status last verified
- Apr 2006
- First submitted
- 27 Mar 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Robinson CB, Fritch M, Hullett L, Petersen MA, Sikkema S, Theuninck L, Timmer K. Development of a protocol to prevent opioid-induced constipation in patients with cancer: a research utilization project. Clin J Oncol Nurs. 2000 Mar-Apr;4(2):79-84.
PubMed 11107380Kavanagh JJ, Copeland LJ, Gershenson DM, Saul PB, Wharton JT, Rutledge FN. Continuous-infusion vinblastine in refractory carcinoma of the cervix: a phase II trial. Gynecol Oncol. 1985 Jun;21(2):211-4. doi: 10.1016/0090-8258(85)90254-9.
PubMed 3988134Wright PS, Thomas SL. Constipation and diarrhea: the neglected symptoms. Semin Oncol Nurs. 1995 Nov;11(4):289-97. doi: 10.1016/s0749-2081(05)80010-5.
PubMed 8578037
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Assessment Process for Constipation in Pediatric Oncology Patients Who Are Receiving Vinca Alkaloids and/or Narcotics
- ClinicalTrials.gov ID
- NCT00032682
- Acronym / sponsor ID
- 020146
- Conditions
- Constipation, Neoplasms
- Keywords
- Bowel Movement, Children, Stool, Symptom Management, Cancer, Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Mar 2002
- Study completion
- Apr 2006
- First posted
- 28 Mar 2002 (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.
This study will evaluate a questionnaire for measuring constipation in children with cancer. The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the presence and severity of constipation in adult patients, but has not been tested in children. The answers to the questionnaire will be used to determine the child's level of constipation and to plan and provide appropriate care.
Patients up to 21 years of age who are enrolled in National Cancer Institute trials and are taking weekly vinca alkaloids or narcotics twice a day or more may be eligible for this study.
On admission to the study, participants will undergo the following procedures:
- The child (or the child's parent) will be interviewed about the child's bowel habits.
- The results of the child's most recent physical examination related to bowel function will be obtained from the medical record for review.
- A registered dietitian will interview the child or parent about the child's eating habits.
During the study, participants will undergo the following procedures:
- A registered nurse will interview the child or parent about the child's bowel movements. This will be done every other day for hospitalized children and three times a week (by phone) for outpatients.
- The child or parent will complete a daily diary of bowel movements.
- A registered dietitian will evaluate the child's nutritional status periodically (by phone).
Children who are not constipated when they enter the study will receive a stool softener every day to prevent constipation. Children who become constipated during the study will be treated as needed. Patients will be followed for 7 days after the last dose of vinca alkaloid or narcotic for a maximum of 6 weeks.
Detailed description
Children with cancer are treated with complex therapies including chemotherapy, radiation, surgical interventions and biotherapy. Treatment with vinca alkaloids and/or narcotics combined with significant lifestyle changes secondary to the disease process can have a negative impact on the child's bowel elimination status. In trying to preserve the child's health and well being, constipation can be minimized or even prevented as an unwanted side effect of the treatments or disease condition.
Despite the widespread knowledge that constipation is prevalent in oncology patients, evidence shows that cancer treatment plans often overlook constipation and reflect the lack of consensus for effective assessment, treatment, and management. The research literature provides a database for addressing particular aspects of constipation. However, few studies address all the factors that affect bowel function and fewer still have recruited pediatric populations.
The Constipation Assessment Scale (CAS) is a valid and reliable measure found to be predictive of the presence and severity of constipation in the adult population, however it has never been tested in the pediatric population. A pilot study utilizing the CAS tool in children diagnosed with cancer will be conducted. The process for evaluating the presence and severity of constipation and the reliability and validity of the CAS tool will be tested. The study population will consist of inpatients and outpatients less than or equal to 21 years old, receiving weekly vinca alkaloids and/or narcotics greater than or equal to 2 times per day for pain management. Patients will be followed for 7 days after the last dose of vinca alkaloid and/or narcotic for a maximum of 6 weeks. Patients will be assessed on admission for bowel function and constipation. The admission assessment will include a nursing and nutrition assessment, review of the history and physical, and the administration of the CAS. Subsequent assessments include nursing, nutrition, administration of the CAS, and a patient daily bowel diary.
All patients regardless of participation in the study will be prescribed interventions based on the bowel prophylaxis and management guidelines established by the NCI POB staff. These guidelines were generated from validated studies, using Medline's criteria for scientific soundness and clinical relevance, in the oncology literature as well as from the experience of the NCI POB staff.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- NCI patients less than or equal to 21 years of age
- Diagnosis of histologically confirmed cancer
- Receiving: weekly vinca alkaloids and/or narcotics greater than or equal to 2 times per day (includes patient controlled analgesia, transdermal analgesic patches)
- ECOG performance score of less than or equal to 2
- Patients, parents, or legal guardian must be able to speak and read English
Key exclusion criteria (4 listed)
- Unable to provide consent/assent
- Patients with acute life threatening infection or bowel obstruction
- Patients with inevaluable bowel function (i.e. patients with a colostomy or paralyzed patients)
- Patients previously enrolled on this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 11107380Robinson CB, Fritch M, Hullett L, Petersen MA, Sikkema S, Theuninck L, Timmer K. Development of a protocol to prevent opioid-induced constipation in patients with cancer: a research utilization project. Clin J Oncol Nurs. 2000 Mar-Apr;4(2):79-84.
- Background: PubMed 3988134Kavanagh JJ, Copeland LJ, Gershenson DM, Saul PB, Wharton JT, Rutledge FN. Continuous-infusion vinblastine in refractory carcinoma of the cervix: a phase II trial. Gynecol Oncol. 1985 Jun;21(2):211-4. doi: 10.1016/0090-8258(85)90254-9.
- Background: PubMed 8578037Wright PS, Thomas SL. Constipation and diarrhea: the neglected symptoms. Semin Oncol Nurs. 1995 Nov;11(4):289-97. doi: 10.1016/s0749-2081(05)80010-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Neoplasms, run by National Institutes of Health Clinical Center (CC) 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 4 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00032682, which also lists 3 linked publications.
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 4 Mar 2008.