Nausea and VomitingPhase 4NCT00418678
A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
A Phase 4 study testing Cesamet in people with Nausea and Vomiting, run by Veeda Oncology at 1 site in United States.
Trial summary
This is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the first 2 cycles of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nausea and Vomiting
- What is being tested?
- Cesamet
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2007
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have signed an IRB-approved informed consent.
- Patients must be receiving moderately emetogenic chemotherapy for the first time with one of the following neoplasms/regimens:
- Non-small cell lung cancer receiving paclitaxel and carboplatin
- Breast cancer receiving cyclophosphamide and doxorubicin
- Colorectal cancer receiving a FOLFOX regimen .
- Patients must have an ECOG Performance Status of 0 or 1 (see Appendix I).
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- Patients must be >18 years of age.
- Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
- Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- Patients must have adequate bone marrow function based on requirements specified in prescribing guidelines for the chemotherapy regimen.
- Patients must have adequate renal and hepatic function based on requirements specified in prescribing guidelines for the chemotherapy regimen.
Who cannot join
- Patients with pre-existing nausea or vomiting.
- Patients with other potential causes of nausea or vomiting, including uncontrolled brain metastases, bowel obstruction, or gastrointestinal hemorrhage.
- Patients with prior adjuvant chemotherapy.
- Patients receiving concurrent radiotherapy to the brain or upper abdomen.
- Patients currently taking other antiemetics.
- Patients who have a history of hypersensitivity to a cannabinoid.
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- Patients with a serious uncontrolled intercurrent medical illness, including serious infection.
- Patients with a current or previous psychiatric disorder (including manic depressive illness and schizophrenia), as the symptoms of these disease states may be unmasked by the use of cannabinoids. Cesamet should be used with caution in individuals receiving other psychoactive drugs.
- Patients with hypertension or heart disease, since Cesamet can elevate supine and standing heart rates and cause postural hypotension.
- Patients with a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of these study drugs.
- Any patient who is pregnant or lactating.
- Any patient who is unable to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the first 2 cycles of chemotherapy.
Phase 1 of study:
Read more
Prior to the first dose of chemotherapy, patients will be instructed on how to complete their patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for pain. In addition, the diary will include a section to list their current pain medications (see Sample Patient Diary in Appendix I). After being instructed, patients will complete the VAS for nausea and for pain, as well as listing their current pain medications. Patients will then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard serotonin antagonist/corticosteroid regimen.
Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day, patients will complete a diary entry pertaining to the preceding 24 hours. The entry will include the number and time of any emetic episodes, any antiemetic rescue medications used, VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the entry will include the above daily parameters but will also include a VAS for pain. In addition, the patient will complete a diary entry pertaining to the 5-day study period that will include pain medications used. Patients will also complete the Functional Living Index - Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in Appendix II).
Patients who either have at least one vomiting episode or at least one report of significant nausea (VAS > 25 mm) during the first 5-day study period will be eligible for the second phase of the study.
Phase 2 of the study:
Patients in the second phase will receive a second cycle of the same chemotherapy. The antiemetic regimen for the second cycle will be the same serotonin antagonist/corticosteroid regimen as they received in Cycle 1, with the addition of Cesamet.
For Cycle 2 of treatment, patients will receive Cesamet 1 mg the night before chemotherapy is to be administered. On the day of chemotherapy (Day 1 of Cycle 2), Cesamet 2 mg will be given 1 to 3 hours before the chemotherapy is administered, in addition to the same serotonin antagonist/corticosteroid regimen as they received in Cycle 1. Patients will receive an additional dose of Cesamet 2 mg the evening of Day 1.
Patients will receive Cesamet 2 mg BID on Days 2-5. Patients will complete the same 5-day diary and FLIC questionnaire as they did in Cycle 1. Beneficial effects of Cesamet will be estimated by comparing the results of the second cycle to the results of the first cycle.
Patients will be evaluated for the first 2 cycles of chemotherapy only.
- Conditions
- Nausea and Vomiting
- Being tested
- Cesamet
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CesametDrug
2 mg BID on Days 2-5.
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate incremental improvement with Cesamet in control of chemotherapy induced nausea and vomiting in patients who have failed to respond adequately to standard antiemetic regimens.
Measured: unk
Secondary outcomes (4)
To determine whether the addition of Cesamet to standard antiemetic regimens leads to incremental benefit in the secondary outcomes of:
Measured: unk
The percent of patients with no emetic episodes, the percentage of patients with no nausea, the percentage of patients with no significant nausea
Measured: unk
time to first emetic episode, decrease in pain over the 5 day study period, decrease in analgesic use over the 5 day study period,Improvement in global quality of life as compared to without cannabinoid use
Measured: unk
the mean (or median) change in VAS score for nausea and pain
Measured: unk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Enrollment was too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and VomitingStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veeda Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Investigators
- Ralph Boccia, M.D., Principal investigator, Center for Cancer and Blood Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418678
- Sponsor's protocol ID
- I-05-017
- Status last verified
- Aug 2008
- First submitted
- 3 Jan 2007
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00418678
- Acronym / sponsor ID
- I-05-017
- Conditions
- Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was too slow
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Veeda OncologyUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Aug 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Jan 2007 (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 is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the first 2 cycles of chemotherapy.
Phase 1 of study:
Prior to the first dose of chemotherapy, patients will be instructed on how to complete their patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for pain. In addition, the diary will include a section to list their current pain medications (see Sample Patient Diary in Appendix I). After being instructed, patients will complete the VAS for nausea and for pain, as well as listing their current pain medications. Patients will then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard serotonin antagonist/corticosteroid regimen.
Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day, patients will complete a diary entry pertaining to the preceding 24 hours. The entry will include the number and time of any emetic episodes, any antiemetic rescue medications used, VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the entry will include the above daily parameters but will also include a VAS for pain. In addition, the patient will complete a diary entry pertaining to the 5-day study period that will include pain medications used. Patients will also complete the Functional Living Index - Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in Appendix II).
Patients who either have at least one vomiting episode or at least one report of significant nausea (VAS > 25 mm) during the first 5-day study period will be eligible for the second phase of the study.
Phase 2 of the study:
Patients in the second phase will receive a second cycle of the same chemotherapy. The antiemetic regimen for the second cycle will be the same serotonin antagonist/corticosteroid regimen as they received in Cycle 1, with the addition of Cesamet.
For Cycle 2 of treatment, patients will receive Cesamet 1 mg the night before chemotherapy is to be administered. On the day of chemotherapy (Day 1 of Cycle 2), Cesamet 2 mg will be given 1 to 3 hours before the chemotherapy is administered, in addition to the same serotonin antagonist/corticosteroid regimen as they received in Cycle 1. Patients will receive an additional dose of Cesamet 2 mg the evening of Day 1.
Patients will receive Cesamet 2 mg BID on Days 2-5. Patients will complete the same 5-day diary and FLIC questionnaire as they did in Cycle 1. Beneficial effects of Cesamet will be estimated by comparing the results of the second cycle to the results of the first cycle.
Patients will be evaluated for the first 2 cycles of chemotherapy only.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have signed an IRB-approved informed consent.
- Patients must be receiving moderately emetogenic chemotherapy for the first time with one of the following neoplasms/regimens:
- Patients must have an ECOG Performance Status of 0 or 1 (see Appendix I).
- Patients must be >18 years of age.
- Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
Key exclusion criteria (12 listed)
- Patients with pre-existing nausea or vomiting.
- Patients with other potential causes of nausea or vomiting, including uncontrolled brain metastases, bowel obstruction, or gastrointestinal hemorrhage.
- Patients with prior adjuvant chemotherapy.
- Patients receiving concurrent radiotherapy to the brain or upper abdomen.
- Patients currently taking other antiemetics.
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 |
|---|---|---|
| Cesamet2 mg BID on Days 2-5. | Drug | – |
Primary outcome
To demonstrate incremental improvement with Cesamet in control of chemotherapy induced nausea and vomiting in patients who have failed to respond adequately to standard antiemetic regimens.
Time frame: unk
4 secondary outcomes
To determine whether the addition of Cesamet to standard antiemetic regimens leads to incremental benefit in the secondary outcomes of:
Time frame: unk
The percent of patients with no emetic episodes, the percentage of patients with no nausea, the percentage of patients with no significant nausea
Time frame: unk
time to first emetic episode, decrease in pain over the 5 day study period, decrease in analgesic use over the 5 day study period,Improvement in global quality of life as compared to without cannabinoid use
Time frame: unk
the mean (or median) change in VAS score for nausea and pain
Time frame: unk
Results and safety
The study was stopped early (reason given: Enrollment was too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.
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Nausea, Vomiting
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.
Ralph Boccia, M.D. principal investigator
Center for Cancer and Blood Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cesamet in people with Nausea and Vomiting, run by Veeda Oncology 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 11 inclusion and 12 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 Dec 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment was too slow). 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?
To demonstrate incremental improvement with Cesamet in control of chemotherapy induced nausea and vomiting in patients who have failed to respond adequately to standard antiemetic regimens. (time frame: unk). 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 Dec 2010.