Healthy Subject Clinical Trial
Official title:
Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa
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 friends/family members, or friends/family members of patients with cancer; 2)
Professionals, staff, or students at the University of Pittsburgh.
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 (70-80°F) 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 (70-80°F) 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-BSE(T)
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 1/3 of the dose) of the SFR-BSE(T)
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-BSE(T)
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-BSE(T) 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 (70-80°F) 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).
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