NCT00064298 · STUDY IN CONTEXT

Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.

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.

→

secondary · POSTED

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.

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-malignant-head-and-neck-neoplasm
nct id: NCT00064298
trial label: Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
outcome key
om-0000
source section id
NCT00064298-om-0000
source outcome index
0
endpoint
Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12
endpoint definition
Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.
time origin
baseline and 12 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
outcome key
om-0001
source section id
NCT00064298-om-0001
source outcome index
1
endpoint
Cell Proliferation (Ki-67) at Baseline and Week 12
endpoint definition
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.
time origin
baseline and 12 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
outcome key
om-0000
arm key
OG000
arm label
Arm I - JuicePlus
regimen
Patients receive oral fruit and vegetable extracts twice daily. fruit and vegetable extracts: Given orally
analyzed count
72
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064298-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
outcome key
om-0000
arm key
OG001
arm label
Arm II - Control
regimen
Patients receive oral placebo twice daily. placebo: Given orally
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064298-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
outcome key
om-0001
arm key
OG000
arm label
Arm I - JuicePlus
regimen
Patients receive oral fruit and vegetable extracts twice daily. fruit and vegetable extracts: Given orally
analyzed count
72
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064298-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
outcome key
om-0001
arm key
OG001
arm label
Arm II - Control
regimen
Patients receive oral placebo twice daily. placebo: Given orally
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064298-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
harm key
EG000
source section id
NCT00064298-ae
event group key
EG000
event group label
Arm I - JuicePlus
serious affected
2
serious at risk
68
other affected
21
other at risk
68
frequency threshold
4.4
collection period
12 weeks
event definition
Sample size is number of participants with follow-up toxicity data recorded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00064298
harm key
EG001
source section id
NCT00064298-ae
event group key
EG001
event group label
Arm II - Control
serious affected
2
serious at risk
59
other affected
16
other at risk
59
frequency threshold
4.4
collection period
12 weeks
event definition
Sample size is number of participants with follow-up toxicity data recorded.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice