Trial Outcomes & Findings for Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer (NCT NCT00064298)
NCT ID: NCT00064298
Last Updated: 2021-09-28
Results Overview
Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2021-09-28
Participant Flow
Participants are recruited from NCI CCOP sites.
Participant milestones
| Measure |
Arm I - JuicePlus
Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally
|
Arm II - Control
Patients receive oral placebo twice daily.
placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
62
|
|
Overall Study
COMPLETED
|
66
|
57
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Arm I - JuicePlus
Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally
|
Arm II - Control
Patients receive oral placebo twice daily.
placebo: Given orally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Disease Progression
|
2
|
1
|
Baseline Characteristics
Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm I - JuicePlus
n=72 Participants
Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally
|
Arm II - Control
n=62 Participants
Patients receive oral placebo twice daily.
placebo: Given orally
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
n=5 Participants
|
59 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: All randomized participants. Not all participants had p27 or Ki67 determined, so the sample sizes for the two outcomes differ from the total sample size.
Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.
Outcome measures
| Measure |
Arm I - JuicePlus
n=72 Participants
Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally
|
Arm II - Control
n=62 Participants
Patients receive oral placebo twice daily.
placebo: Given orally
|
|---|---|---|
|
Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12
Baseline
|
18.6 percentage of cells
Standard Error 1.52
|
15.1 percentage of cells
Standard Error 1.42
|
|
Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12
12 weeks
|
17.0 percentage of cells
Standard Error 1.39
|
14.5 percentage of cells
Standard Error 1.57
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: All participants randomized. Not all participants had p27 or Ki67 data so the sample sizes for the primary and secondary analyses differ from the overall sample size.
Cell proliferation (Ki-67) at baseline and week 12. Ki67 is a cell proliferation associated nuclear protein. It is measured continuously. Higher values are worse.
Outcome measures
| Measure |
Arm I - JuicePlus
n=72 Participants
Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally
|
Arm II - Control
n=62 Participants
Patients receive oral placebo twice daily.
placebo: Given orally
|
|---|---|---|
|
Cell Proliferation (Ki-67) at Baseline and Week 12
Baseline
|
26.8 percentage of cells
Standard Error 1.20
|
26.2 percentage of cells
Standard Error 1.28
|
|
Cell Proliferation (Ki-67) at Baseline and Week 12
12 Weeks
|
27.1 percentage of cells
Standard Error 1.43
|
27.0 percentage of cells
Standard Error 1.55
|
Adverse Events
Arm I - JuicePlus
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm II - Control
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - JuicePlus
n=68 participants at risk
Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally
|
Arm II - Control
n=59 participants at risk
Patients receive oral placebo twice daily.
placebo: Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Dehydration
|
1.5%
1/68 • Number of events 1 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
0.00%
0/59 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Nervous system disorders
Headache
|
1.5%
1/68 • Number of events 1 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
0.00%
0/59 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
General disorders
Pain
|
2.9%
2/68 • Number of events 2 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
0.00%
0/59 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Musculoskeletal and connective tissue disorders
Ataxia
|
0.00%
0/68 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
1.7%
1/59 • Number of events 1 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
General disorders
Fatigue
|
0.00%
0/68 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
1.7%
1/59 • Number of events 1 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Psychiatric disorders
Mood Change
|
0.00%
0/68 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
1.7%
1/59 • Number of events 1 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
Other adverse events
| Measure |
Arm I - JuicePlus
n=68 participants at risk
Patients receive oral fruit and vegetable extracts twice daily.
fruit and vegetable extracts: Given orally
|
Arm II - Control
n=59 participants at risk
Patients receive oral placebo twice daily.
placebo: Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
4/68 • Number of events 5 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
6.8%
4/59 • Number of events 5 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Musculoskeletal and connective tissue disorders
Dysphagia
|
5.9%
4/68 • Number of events 5 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
0.00%
0/59 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Metabolism and nutrition disorders
Fatigue
|
4.4%
3/68 • Number of events 7 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
3.4%
2/59 • Number of events 7 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/68 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
5.1%
3/59 • Number of events 4 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Gastrointestinal disorders
Heartburn
|
10.3%
7/68 • Number of events 7 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
10.2%
6/59 • Number of events 12 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/68 • Number of events 1 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
5.1%
3/59 • Number of events 3 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
General disorders
Pain
|
4.4%
3/68 • Number of events 3 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
5.1%
3/59 • Number of events 3 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
General disorders
SOB
|
5.9%
4/68 • Number of events 4 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
0.00%
0/59 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
|
General disorders
Taste Alteration
|
4.4%
3/68 • Number of events 11 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
1.7%
1/59 • Number of events 2 • 12 weeks
Sample size is number of participants with follow-up toxicity data recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place