Trial · NCT00827372
A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer
NCT00827372, Phase 2, Completed, Kathy Miller; results first posted 2014-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer. Trials, record NCT00827372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00827372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer
- NCT number
- NCT00827372
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Kathy Miller
- Conditions
- Lymphedema
- Interventions
- Pazopanib
- First posted
- 2009-01-22
- Last updated
- 2023-10-16
- Results first posted
- 2014-10-16
- Limitations and caveats
This study was to enroll 14-15 patients. Due to toxicity and enough patients met the definition of response, enrollment to this study was halted early, leading to a smaller number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Volume Ipsilateral Lymphedema in Arm | Baseline through Cycle 6, Day 1 | The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days). |
| Secondary | Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm | First 24 hours after drug was administered | Interstitial fluid pressure was reported at 24 hours. This is the difference in the last-first reading, affected arm. To assess the degree of improvement in arm edema as measured by changes in interstitial fluid pressure (ECF volume using an automated device lymphometer) |
| Secondary | Change in Impedance or ECF Volume in the Arm | Baseline, and Cycle 2, Day 1 | Arm impedance was reported at two baseline readings and for Cycle 2, Day 1. To assess the degree of improvement in arm edema as measured by changes in arm impedance (ECF volume using an automated device lymphometer). Data reported is the ratio of the impedance in the affected versus unaffected arm |
| Secondary | Number of Patients With Trt Related Grade 2+ AEs | End of Treatment | This is the number of patients who had greater than or equal to Grade 2 Adverse Events related to treatment. This also includes the number of patients who had treatment related Grade 2 or greater Adverse Events that lasted more than 2 weeks (14 days) and excluded events of hypertension (labeled as 'special'). |
| Secondary | Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions) | Baseline through Cycle 6, Day 1 | The quality of life questionnaire (FACT-B+4 lymphedema questions) was given at various timepoints during the study. The values for the subscales are given for baseline, Cycle 1:Day 1, Cycle 2:Day 1, and Cycle 6:Day 1. Physical Well-Being (PWB; sum of 7 items, point range 0-28) Social /Family Well-Being (SWB, sum of 7-items, point range 0-28) Emotional Well-Being (EWB; sum of 6-items, point range 0-24) Functional Well-Being (FWB; sum of 7-items, point range 0-28) Additional Concerns (BCS; sum of 9-items, point range 0-36) Arm subscale (AS; sum of 5-items, point range 0-20) -- This was not collected in Cycle 1 or 2. Fact-B+4 score=Sum of PWB, SWB, EWB, FWB, BCS, AS, point range 0-164 Trial Outcome Index=Sum of PWB, FWB, BCS, point range 0-92 Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108 Fact-B score=sum of PWB, SWB, EWB, FWB, BCS, point range 0-144 Note: The higher the score, the better the outcome |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Volume Ipsilateral Lymphedema in Arm | Baseline through Cycle 6, Day 1 | All patients with non-missing results. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment. | mL | MEAN |
| SECONDARY | Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm | First 24 hours after drug was administered | All patients with non-missing results at both baseline and at 24 hours. | mm Hg | MEAN |
| SECONDARY | Change in Impedance or ECF Volume in the Arm | Baseline, and Cycle 2, Day 1 | All patients with non-missing results. This includes 8 patients at the first baseline, 10 patients at the second baseline, and 7 patients at Cycle 2, Day 1. | ratio | MEDIAN |
| SECONDARY | Number of Patients With Trt Related Grade 2+ AEs | End of Treatment | All treated patients | participants | NUMBER |
| SECONDARY | Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions) | Baseline through Cycle 6, Day 1 | All patients with non-missing results. There were 10 patients at baseline/Cycle 1, Day 1, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Volume Ipsilateral Lymphedema in Arm | Overall Study | Change from Baseline to Cycle 2, Day 1 | -161.0 | Standard Deviation 189.7 | mL |
| Change in Volume Ipsilateral Lymphedema in Arm | Overall Study | Change from Baseline to Cycle 6, Day 1 | -372.8 | Standard Deviation 233.2 | mL |
| Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm | Overall | -0.76 | Standard Deviation 0.28 | mm Hg | |
| Change in Impedance or ECF Volume in the Arm | Overall | Impedence Baseline 1 | 1.39 | Standard Deviation 0.34 | ratio |
| Change in Impedance or ECF Volume in the Arm | Overall | Impedence Baseline 2 | 1.43 | Standard Deviation 0.31 | ratio |
| Change in Impedance or ECF Volume in the Arm | Overall | Impedence Cycle 2, Day 1 | 1.46 | Standard Deviation 0.25 | ratio |
| Number of Patients With Trt Related Grade 2+ AEs | Overall | Patients with Trt Related Grade 2+ AEs | 9 | participants | |
| Number of Patients With Trt Related Grade 2+ AEs | Overall | Patients with Trt Related Grade 2+ AEs (special) | 7 | participants | |
| Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions) | Overall | Cycle 1, Day 1 Physical Well Being | 25.3 | Standard Deviation 2.8 | Units on a scale |
| Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions) | Overall | Cycle 1, Day 1 Social Well Being | 24.9 | Standard Deviation 2.1 | Units on a scale |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study | 10 | |
| Overall Study | COMPLETED | Overall Study | 2 | |
| Overall Study | NOT COMPLETED | Overall Study | 8 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | VISION-BLURRED VISION | Eye disorders | Overall | 1 | 10 | 1 |
| other | MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY | Gastrointestinal disorders | Overall | 5 | 10 | 5 |
| other | CONSTIPATION | Gastrointestinal disorders | Overall | 2 | 10 | 2 |
| other | DIARRHEA | Gastrointestinal disorders | Overall | 6 | 10 | 6 |
| other | FLATULENCE | Gastrointestinal disorders | Overall | 1 | 10 | 1 |
| other | HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | Overall | 4 | 10 | 4 |
| other | NAUSEA | Gastrointestinal disorders | Overall | 4 | 10 | 4 |
| other | PAIN - ABDOMEN NOS | Gastrointestinal disorders | Overall | 1 | 10 | 1 |
| other | PAIN - ORAL-GUMS | Gastrointestinal disorders | Overall | 1 | 10 | 1 |
| other | TASTE ALTERATION (DYSGEUSIA) | Gastrointestinal disorders | Overall | 6 | 10 | 6 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall | ||
| Total, other adverse events | Overall | 10 | 10 |
| Total, serious adverse events | Overall | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00827372
GET https://conductscience.org/api/trials/v1/NCT00827372/results?page=2