Recruitment

Recruitment Status
Completed

Inclusion Criterias

Karnofsky Performance Scale ≥90% (Appendix C)
Willing to avoid cruciferous vegetables during the study interventions (Appendix D)
Both males and females are eligible.
...
Karnofsky Performance Scale ≥90% (Appendix C)
Willing to avoid cruciferous vegetables during the study interventions (Appendix D)
Both males and females are eligible.
Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
Members of all racial and ethnic groups are eligible.
Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B).
No current or former diagnosis of cancer, with the exception of: excised and cured non-melanoma skin cancer; or carcinoma in situ of the cervix
No chronic use of steroids
Potential effects of Broccoli sprout extract on the developing human fetus: The effects of Broccoli Sprout Extract on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation
Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer.
No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix A)
Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
Able to provide written, informed consent
No history of food intolerance to broccoli or pineapple and lime juices
No chronic anticoagulation
For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention

Summary

Conditions
Healthy Subject
Type
Interventional
Phase
Early Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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).

Inclusion Criterias

Karnofsky Performance Scale ≥90% (Appendix C)
Willing to avoid cruciferous vegetables during the study interventions (Appendix D)
Both males and females are eligible.
...
Karnofsky Performance Scale ≥90% (Appendix C)
Willing to avoid cruciferous vegetables during the study interventions (Appendix D)
Both males and females are eligible.
Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
Members of all racial and ethnic groups are eligible.
Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B).
No current or former diagnosis of cancer, with the exception of: excised and cured non-melanoma skin cancer; or carcinoma in situ of the cervix
No chronic use of steroids
Potential effects of Broccoli sprout extract on the developing human fetus: The effects of Broccoli Sprout Extract on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation
Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer.
No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix A)
Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
Able to provide written, informed consent
No history of food intolerance to broccoli or pineapple and lime juices
No chronic anticoagulation
For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention

Locations

Pittsburgh, Pennsylvania, 15232
Pittsburgh, Pennsylvania, 15213
Pittsburgh, Pennsylvania, 15232
Pittsburgh, Pennsylvania, 15213

Tracking Information

NCT #
NCT02023931
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Julie E Bauman, MD University ofPittsburgh
  • Julie E Bauman, MD University ofPittsburgh