Gastric CancerNCT00394602
Chemoradiation-Induced Nausea and Emesis: Quality of Life
An observational study of Gastric Cancer and Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The primary objectives of this study are: 1. To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation. 1. To compare preferences of cancer patients to those of healthy individuals. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Pancreatic Cancer, Cervical Cancer
- What is being tested?
- Interview and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2004to 8 May 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving chemoradiation for abdominal-pelvic tumors and healthy controls.
Who may be able to join
- Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors (gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar, endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]
- Patients receiving concurrent abdominal-pelvic radiation and single agent or combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine, gemcitabine, or bevacizumab (Avastin).
- Patients must be least 18 years of age
- Controls must be individuals with no prior cancer diagnosis
- Controls must be at least 18 years of age
- Controls must be the caregivers of patients on this study
Who cannot join
- Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
- Patients who are not scheduled to receive chemoradiation treatment
- Patients who are not at least 18 years of age
- Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer)
- Controls - individuals who are not at least 18 years of age
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: Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life
The primary objectives of this study are:
- To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
- To compare preferences of cancer patients to those of healthy individuals.
- To compare how patients' preferences for side-effects of chemoradiation change over time.
- To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
- To determine the impact of nausea and vomiting associated with chemoradiation on patients' quality of life and evaluate potential change throughout the duration of chemoradiation treatment.
Read the detailed description
You will be interviewed about your perceptions of side effects that are related to your chemoradiation treatment. The interview will take about 20 minutes. You will be interviewed at the beginning of your chemoradiation treatment, 3 weeks after treatment starts, and at the first follow-up appointment after chemoradiation treatment ends.
Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation therapy.
You will also receive a packet of 3 questionnaires to complete at different times during and after treatment. The questionnaires include a quality of life survey that asks about physical, social, and emotional well-being, a self-report symptom evaluation that will ask whether you are experiencing any particular side effects and if so how much it bothers you, and a brief survey to asks questions about anxiety and distress.
The questionnaires should take about 20 minutes each to complete. The questionnaire packet will be given to patients at the beginning of chemoradiation treatment, 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends. If the you do not have time to complete the questionnaires, a stamped, addressed envelop will be given so that you can mail the completed packet back to the research team.
Your participation in this research study will be over about 4-6 weeks after chemoradiation treatment ends.
This is an investigational study. Up to 208 individuals (104 patients and 104 caregivers) will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Gastric Cancer, Pancreatic Cancer, Cervical Cancer, Vulvar Cancer, Endometrial Cancer, Anal Cancer
- Being tested
- Interview, Questionnaire
- Keywords
- Gastric Cancer, Pancreatic Cancer, Cervical Cancer, Vulvar Cancer, Endometrial Cancer, Anal Cancer, Quality of Life, Questionnaire, Interview, Emesis, Nausea, Survey
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Endometrial Neoplasms, Anus Neoplasms, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Interview regarding perceptions of side effects that are related to chemoradiation treatment.
QuestionnaireOther
Also called Survey
3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients receiving chemoradiation for abdominal-pelvic tumors. Receives: Behavioral: Interview; Other: Questionnaire | |
| Caregiver Controls | Healthy controls with no prior cancer diagnosis. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Quality of Life + Symptom Assessment Data
Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual. Patients and controls compared with respect to preference data. The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.
Measured: Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study start7 Apr 2004
- Primary completion8 May 2019
- Study completion8 May 2019
Why it stopped: Requested by PI during yearly Continuing Review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Charlotte C. Sun, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394602
- Sponsor's protocol ID
- 2003-0529
- Status last verified
- Dec 2019
- First submitted
- 30 Oct 2006
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life
- ClinicalTrials.gov ID
- NCT00394602
- Acronym / sponsor ID
- 2003-0529
- Conditions
- Gastric Cancer, Pancreatic Cancer, Cervical Cancer, Vulvar Cancer, Endometrial Cancer, Anal Cancer
- Keywords
- Gastric Cancer, Pancreatic Cancer, Cervical Cancer, Vulvar Cancer, Endometrial Cancer, Anal Cancer, Quality of Life, Questionnaire
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Requested by PI during yearly Continuing Review
- Enrolment
- 207 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 7 Apr 2004 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 1 Nov 2006 (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 primary objectives of this study are:
- To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
- To compare preferences of cancer patients to those of healthy individuals.
- To compare how patients' preferences for side-effects of chemoradiation change over time.
- To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
- To determine the impact of nausea and vomiting associated with chemoradiation on patients' quality of life and evaluate potential change throughout the duration of chemoradiation treatment.
Detailed description
You will be interviewed about your perceptions of side effects that are related to your chemoradiation treatment. The interview will take about 20 minutes. You will be interviewed at the beginning of your chemoradiation treatment, 3 weeks after treatment starts, and at the first follow-up appointment after chemoradiation treatment ends.
Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation therapy.
You will also receive a packet of 3 questionnaires to complete at different times during and after treatment. The questionnaires include a quality of life survey that asks about physical, social, and emotional well-being, a self-report symptom evaluation that will ask whether you are experiencing any particular side effects and if so how much it bothers you, and a brief survey to asks questions about anxiety and distress.
The questionnaires should take about 20 minutes each to complete. The questionnaire packet will be given to patients at the beginning of chemoradiation treatment, 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends. If the you do not have time to complete the questionnaires, a stamped, addressed envelop will be given so that you can mail the completed packet back to the research team.
Your participation in this research study will be over about 4-6 weeks after chemoradiation treatment ends.
This is an investigational study. Up to 208 individuals (104 patients and 104 caregivers) will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: Interview, Other: QuestionnairePatients receiving chemoradiation for abdominal-pelvic tumors. |
| Caregiver Controls | – | Behavioral: InterviewHealthy controls with no prior cancer diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving chemoradiation for abdominal-pelvic tumors and healthy controls.
Key inclusion criteria (6 listed)
- Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors (gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar, endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]
- Patients receiving concurrent abdominal-pelvic radiation and single agent or combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine, gemcitabine, or bevacizumab (Avastin).
- Patients must be least 18 years of age
- Controls must be individuals with no prior cancer diagnosis
- Controls must be at least 18 years of age
Key exclusion criteria (5 listed)
- Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
- Patients who are not scheduled to receive chemoradiation treatment
- Patients who are not at least 18 years of age
- Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer)
- Controls - individuals who are not at least 18 years of age
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 |
|---|---|---|
| InterviewInterview regarding perceptions of side effects that are related to chemoradiation treatment. | Behavioural | Caregiver Controls, Patients |
| QuestionnaireAlso: Survey3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete. | Other | Patients |
Primary outcome
Longitudinal Quality of Life + Symptom Assessment Data
Time frame: Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.
Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual. Patients and controls compared with respect to preference data. The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.
Results and safety
The study was stopped early (reason given: Requested by PI during yearly Continuing Review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- 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.
Charlotte C. Sun, MD 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 Gastric Cancer and Pancreatic 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 6 inclusion and 5 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 2 Jan 2020. 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: Requested by PI during yearly 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?
Longitudinal Quality of Life + Symptom Assessment Data (time frame: Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.). 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 2 Jan 2020.