Colorectal CancerNCT00777192
Longitudinal Study of Symptoms in Colorectal Cancer
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 509 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 27 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.
Who may be able to join
- Patients with colorectal cancer meeting one of the following criteria: 1. naive to oxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane, Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study cohort 1); or 2. during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). This second cohort may include patients with colorectal cancer from the original 12-month study (the longitudinal cohort), both those who completed the study and those who dropped out. It may also include new patients who did not participate in the longitudinal phase of the study.
- Patients >= 18 years old.
- Patients who speak English or Spanish.
Who cannot join
- Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common Terminology Criteria (CTCv3.0).
- Patients who do not understand the intent of the study.
- Cohort 1 patients unable to use the interactive voice response (IVR) system due to physical limitations (e.g., hearing impairment).
- Cohort 1 patients with a history of inflammatory bowel disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer
The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.
Read the detailed description
If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled visit. The questionnaires are designed to measure pain and other symptoms, your mood, and your quality of life.
You will also give a tissue sample by inserting a cotton tipped swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about 1 minute at the most.
Completing the 5 questionnaires and the swab sample should take about 30 minutes.
Length of Study:
After you complete the questionnaires and the swab sample collection, your active participation in this study will be over.
This is an investigational study.
Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Colorectal Cancer
- Being tested
- Questionnaires
- Keywords
- colon cancer, Cancers of the colon and rectum, Oxaliplatin, oxaliplatin chemotherapy, inflammatory cytokines, neurocognitive symptoms, neuropsychiatric symptoms
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Symptoms in Colorectal Cancer | Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients
Measured: 5 Years
Secondary outcomes (2)
Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time
Measured: 5 Years
Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients
Measured: Neuropsychological test battery at baseline and 3 + 6 month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startAug 2008
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Why it stopped: Terminated at continuing review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Xin Shelley Wang, MD. MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777192
- Sponsor's protocol ID
- 2007-0637
- Status last verified
- May 2019
- First submitted
- 20 Oct 2008
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang XS, Shi Q, Dougherty PM, Eng C, Mendoza TR, Williams LA, Fogelman DR, Cleeland CS. Prechemotherapy Touch Sensation Deficits Predict Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer. Oncology. 2016;90(3):127-35. doi: 10.1159/000443377. Epub 2016 Feb 17.
PubMed 26882477
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00777192
- Acronym / sponsor ID
- 2007-0637
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, Cancers of the colon and rectum, Oxaliplatin, oxaliplatin chemotherapy, inflammatory cytokines, neurocognitive symptoms, neuropsychiatric symptoms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated at continuing review
- Enrolment
- 509 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2008 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 22 Oct 2008 (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 goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.
Detailed description
If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled visit. The questionnaires are designed to measure pain and other symptoms, your mood, and your quality of life.
You will also give a tissue sample by inserting a cotton tipped swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about 1 minute at the most.
Completing the 5 questionnaires and the swab sample should take about 30 minutes.
Length of Study:
After you complete the questionnaires and the swab sample collection, your active participation in this study will be over.
This is an investigational study.
Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptoms in Colorectal Cancer | – | Behavioral: QuestionnairesColorectal Cancer Patients Receiving Oxaliplatin Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.
Key inclusion criteria (3 listed)
- Patients with colorectal cancer meeting one of the following criteria: 1. naive to oxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane, Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study cohort 1); or 2. during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). This second cohort may include patients with colorectal cancer from the original 12-month study (the longitudinal cohort), both those who completed the study and those who dropped out. It may also include new patients who did not participate in the longitudinal phase of the study.
- Patients >= 18 years old.
- Patients who speak English or Spanish.
Key exclusion criteria (4 listed)
- Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common Terminology Criteria (CTCv3.0).
- Patients who do not understand the intent of the study.
- Cohort 1 patients unable to use the interactive voice response (IVR) system due to physical limitations (e.g., hearing impairment).
- Cohort 1 patients with a history of inflammatory bowel disease.
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 |
|---|---|---|
| Questionnaires20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life | Behavioural | Symptoms in Colorectal Cancer |
Primary outcome
Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients
Time frame: 5 Years
2 secondary outcomes
Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time
Time frame: 5 Years
Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients
Time frame: Neuropsychological test battery at baseline and 3 + 6 month follow ups
Results and safety
The study was stopped early (reason given: Terminated at continuing review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Derived from this study: PubMed 26882477Wang XS, Shi Q, Dougherty PM, Eng C, Mendoza TR, Williams LA, Fogelman DR, Cleeland CS. Prechemotherapy Touch Sensation Deficits Predict Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer. Oncology. 2016;90(3):127-35. doi: 10.1159/000443377. Epub 2016 Feb 17.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Xin Shelley Wang, MD. MPH principal investigator
M.D. Anderson Cancer Center
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 Colorectal Cancer, run by M.D. Anderson Cancer Center 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 3 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: stopped early, as of the sponsor's last update on 29 May 2019. 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 was stopped early (reason given: Terminated at continuing review). Results are not available in the source record.
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?
Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00777192, which also lists 1 linked publication.
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 29 May 2019.