Ignite Creation Date:
2024-05-06 @ 2:20 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02023931
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2013-12-24
Brief Title:
Broccoli Sprout Extracts in Healthy Volunteers A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa
Sponsor:
Julie E Bauman MD MPH
Organization:
University of Pittsburgh
Study Overview
Official Title:
Broccoli Sprout Extracts in Healthy Volunteers A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BSE
Brief Summary:
A pilot study has been designed to determine primary objective if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling including NQO1 GSTs and AKRs in the oral mucosa of healthy subjects Quantitative distribution data and preliminary effect size for specific Nrf2 targets as measured in serial buccal cell scrapings will be determined during the course of 3-day exposures to three BSE regimens These data will inform the design of a randomized phase II chemoprevention trial in patients with HPV-negative HNSCC
Ten healthy volunteers will be recruited for this pilot study Age 18 years both male and female 1 The non-cancer population presenting to the University of Pittsburgh Eye and Ear Institute or the Hillman Cancer Center This may include patients with benign disease or their friendsfamily members or friendsfamily members of patients with cancer 2 Professionals staff or students at the University of Pittsburgh
Ten healthy volunteers will be recruited for this pilot study Age 18 years both male and female 1 The non-cancer population presenting to the University of Pittsburgh Eye and Ear Institute or the Hillman Cancer Center This may include patients with benign disease or their friendsfamily members or friendsfamily members of patients with cancer 2 Professionals staff or students at the University of Pittsburgh
Detailed Description:
Intervention 1 GRR-BSE
If eligible participants may undergo baseline visit procedures immediately following the screening visit same day If necessary for logistical purposes participants may return for the baseline visit and initiation of the first BSE intervention any time during the 14 days following eligibility assessment At the baseline visit day 1 participants will undergo baseline blood and buccal cell collection Blood collection will be performed by a trained phlebotomist Buccal cell collection will be conducted by a trained research coordinator the principal investigator or a co-investigator Participants will receive written and verbal instructions and an intervention diary for documentation of the BSE drink details of the intervention timeline including overnight voids blood and buccal cell collection and days of GRR-BSE consumption Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention For overnight voids participants will be instructed to begin collecting urine at 5 pm and to collect all urine through the first morning void on the following day The intervention diary will have space for participants to record the date and time of each GRR-BSE consumption and space for subjective comments regarding taste and tolerability Participants will be provided with 1 a collection bottle for overnight urine collection 2 three frozen GRR-BSE beverages in an insulated cooler bag with a frozen blue-ice block 3 the intervention diary and instructions as stated above
Participants will store the frozen GRR-BSE beverages in their home freezer On the evening of day 1 participants will collect a baseline overnight void which will be returned to the study team on day 2 Each evening for 3 evenings days 2-4 between 5pm and 8pm participants will thaw and consume one GRR-BSE beverage Beverages may be thawed at room temperature for 1-2 hours or in a lukewarm 70-80F water bath for 20-30 minutes Participants will record the time of consumption on the intervention diary AE assessment and buccal cell collections will be conducted on days 3 4 and 5 between 8 am and 1 pm by a study investigator or trained research coordinator On the evening of day 4 participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary Blood collection will occur again on day 5 between 8 am and 1 pm
Participants will then undergo a minimum 3 day washout Day 5 of the intervention which does not include a GRR-BSE dose counts as the first day of the washout period
Intervention 2 SFR-BSE
At the baseline visit for intervention 2 day 1 participants will undergo baseline blood and buccal cell collection Blood collection will be performed by a trained phlebotomist Buccal cell collection will be conducted by a trained research coordinator the principal investigator or a co-investigator Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE drink details of the intervention timeline including overnight voids blood and buccal cell collection and days of SFR-BSE consumption Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention For overnight voids participants will be instructed to begin collecting urine at 5 pm and to collect all urine through the first morning void on the following day The intervention diary will have space for participants to record the date and time of each SFR-BSE consumption and space for subjective comments regarding taste and tolerability Participants will be provided with 1 a collection bottle for overnight urine collection including instructions for collection 2 three frozen SFR-BSE beverages in an insulated cooler bag with a frozen blue-ice block 3 the intervention diary and instructions as stated above
Participants will store the frozen SFR-BSE beverages in their home freezer On the evening of day 1 participants will collect a baseline overnight void which will be returned to the study team on day 2 Each evening for 3 evenings days 2-4 between 5pm and 8pm participants will thaw and consume one SFR-BSE beverage Beverages may be thawed at room temperature for 1-2 hours or in a lukewarm 70-80F water bath for 20-30 minutes Participants will record the time of consumption on the intervention diary AE assessment and buccal cell collections will be conducted on days 3 4 and 5 between 8 am and 1 pm by a study investigator or a trained research coordinator On the evening of day 4 participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary Blood collection will occur again on day 5 between 8 am and 1 pm
Participants will then undergo a minimum 3 day washout Day 5 of the intervention which does not include a SFR-BSE dose counts as the first day of the washout period
Intervention 3 SFR-BSET
At the baseline visit for intervention 3 day 1 participants will undergo baseline blood and buccal cell collection Blood collection will be performed by a trained phlebotomist Buccal cell collection will be conducted by a trained research coordinator the principal investigator or a co-investigator Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE T application details of the intervention timeline including overnight voids blood and buccal cell collection and days of SFR-BSE T application Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention For overnight voids participants will be instructed to begin collecting urine at 5 pm and to collect all urine through the first morning void on the following day Participants will be explicitly instructed that intervention 3 is topical application only Participants will be instructed to take one mouthful approximately 30 mL or 13 of the dose of the SFR-BSET beverage swish gargle and hold in the mouth for 2-3 minutes then spit out This will be repeated twice for a total of 3 swish gargle hold and spit applications until the beverage is gone aiming for a total exposure time of 6-8 minutes The intervention diary will have space for participants to record the date time and duration of each SFR-BSET topical application and space for subjective comments regarding taste and tolerability Participants will be provided with 1 a collection bottle for overnight urine collection including instructions for collection 2 three frozen SFR-BSE T beverages in an insulated cooler bag with a frozen blue-ice block 3 the intervention diary and instructions as stated above
Participants will store the frozen SFR-BSET beverages in their home freezer On the evening of day 1 participants will collect a baseline overnight void which will be returned to the study team on day 2 Each evening for 3 evenings days 2-4 between 5pm and 8pm participants will thaw and consume one SFR-BSE beverage Beverages may be thawed at room temperature for 1-2 hours or in a lukewarm 70-80F water bath for 20-30 minutes Participants will record the time and duration of each topical application on the intervention diary AE assessment and buccal cell collections will be conducted on days 3 4 and 5 between 8 am and 1 pm by a study investigator On the evening of day 4 participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary Blood collection will occur again on day 5 between 8 am and 1 pm
If eligible participants may undergo baseline visit procedures immediately following the screening visit same day If necessary for logistical purposes participants may return for the baseline visit and initiation of the first BSE intervention any time during the 14 days following eligibility assessment At the baseline visit day 1 participants will undergo baseline blood and buccal cell collection Blood collection will be performed by a trained phlebotomist Buccal cell collection will be conducted by a trained research coordinator the principal investigator or a co-investigator Participants will receive written and verbal instructions and an intervention diary for documentation of the BSE drink details of the intervention timeline including overnight voids blood and buccal cell collection and days of GRR-BSE consumption Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention For overnight voids participants will be instructed to begin collecting urine at 5 pm and to collect all urine through the first morning void on the following day The intervention diary will have space for participants to record the date and time of each GRR-BSE consumption and space for subjective comments regarding taste and tolerability Participants will be provided with 1 a collection bottle for overnight urine collection 2 three frozen GRR-BSE beverages in an insulated cooler bag with a frozen blue-ice block 3 the intervention diary and instructions as stated above
Participants will store the frozen GRR-BSE beverages in their home freezer On the evening of day 1 participants will collect a baseline overnight void which will be returned to the study team on day 2 Each evening for 3 evenings days 2-4 between 5pm and 8pm participants will thaw and consume one GRR-BSE beverage Beverages may be thawed at room temperature for 1-2 hours or in a lukewarm 70-80F water bath for 20-30 minutes Participants will record the time of consumption on the intervention diary AE assessment and buccal cell collections will be conducted on days 3 4 and 5 between 8 am and 1 pm by a study investigator or trained research coordinator On the evening of day 4 participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary Blood collection will occur again on day 5 between 8 am and 1 pm
Participants will then undergo a minimum 3 day washout Day 5 of the intervention which does not include a GRR-BSE dose counts as the first day of the washout period
Intervention 2 SFR-BSE
At the baseline visit for intervention 2 day 1 participants will undergo baseline blood and buccal cell collection Blood collection will be performed by a trained phlebotomist Buccal cell collection will be conducted by a trained research coordinator the principal investigator or a co-investigator Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE drink details of the intervention timeline including overnight voids blood and buccal cell collection and days of SFR-BSE consumption Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention For overnight voids participants will be instructed to begin collecting urine at 5 pm and to collect all urine through the first morning void on the following day The intervention diary will have space for participants to record the date and time of each SFR-BSE consumption and space for subjective comments regarding taste and tolerability Participants will be provided with 1 a collection bottle for overnight urine collection including instructions for collection 2 three frozen SFR-BSE beverages in an insulated cooler bag with a frozen blue-ice block 3 the intervention diary and instructions as stated above
Participants will store the frozen SFR-BSE beverages in their home freezer On the evening of day 1 participants will collect a baseline overnight void which will be returned to the study team on day 2 Each evening for 3 evenings days 2-4 between 5pm and 8pm participants will thaw and consume one SFR-BSE beverage Beverages may be thawed at room temperature for 1-2 hours or in a lukewarm 70-80F water bath for 20-30 minutes Participants will record the time of consumption on the intervention diary AE assessment and buccal cell collections will be conducted on days 3 4 and 5 between 8 am and 1 pm by a study investigator or a trained research coordinator On the evening of day 4 participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary Blood collection will occur again on day 5 between 8 am and 1 pm
Participants will then undergo a minimum 3 day washout Day 5 of the intervention which does not include a SFR-BSE dose counts as the first day of the washout period
Intervention 3 SFR-BSET
At the baseline visit for intervention 3 day 1 participants will undergo baseline blood and buccal cell collection Blood collection will be performed by a trained phlebotomist Buccal cell collection will be conducted by a trained research coordinator the principal investigator or a co-investigator Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE T application details of the intervention timeline including overnight voids blood and buccal cell collection and days of SFR-BSE T application Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention For overnight voids participants will be instructed to begin collecting urine at 5 pm and to collect all urine through the first morning void on the following day Participants will be explicitly instructed that intervention 3 is topical application only Participants will be instructed to take one mouthful approximately 30 mL or 13 of the dose of the SFR-BSET beverage swish gargle and hold in the mouth for 2-3 minutes then spit out This will be repeated twice for a total of 3 swish gargle hold and spit applications until the beverage is gone aiming for a total exposure time of 6-8 minutes The intervention diary will have space for participants to record the date time and duration of each SFR-BSET topical application and space for subjective comments regarding taste and tolerability Participants will be provided with 1 a collection bottle for overnight urine collection including instructions for collection 2 three frozen SFR-BSE T beverages in an insulated cooler bag with a frozen blue-ice block 3 the intervention diary and instructions as stated above
Participants will store the frozen SFR-BSET beverages in their home freezer On the evening of day 1 participants will collect a baseline overnight void which will be returned to the study team on day 2 Each evening for 3 evenings days 2-4 between 5pm and 8pm participants will thaw and consume one SFR-BSE beverage Beverages may be thawed at room temperature for 1-2 hours or in a lukewarm 70-80F water bath for 20-30 minutes Participants will record the time and duration of each topical application on the intervention diary AE assessment and buccal cell collections will be conducted on days 3 4 and 5 between 8 am and 1 pm by a study investigator On the evening of day 4 participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary Blood collection will occur again on day 5 between 8 am and 1 pm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P50CA097190-09 | NIH | None | httpsreporternihgovquickSearch5P50CA097190-09 |