Trial · NCT01763931
DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
NCT01763931, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2020-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer. Trials, record NCT01763931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01763931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
- NCT number
- NCT01763931
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Breast Cancer
- Interventions
- Digoxin
- First posted
- 2013-01-09
- Last updated
- 2020-01-31
- Results first posted
- 2020-01-31
- Limitations and caveats
The pre-operative setting was challenging for accrual and we did not meet our accrual goals. Therefore, the study was closed to accrual early. Only 6 out of 64 planned participants were enrolled, therefore there was not enough data to analyze.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HIF-1α Protein Expression | Baseline (biopsy prior to surgery) and at the end of 2 weeks digoxin treatment | To assess whether two weeks of daily oral digoxin therapy, as compared to no study drug, reduces the expression of Hypoxia-inducible factor (HIF)-1α protein, measured by immunohistochemistry (IHC), in surgically resected breast cancer tissue obtained from women undergoing lumpectomy or mastectomy for invasive breast cancer. |
| Secondary | Number of Participants With Adverse Events With Digoxin Treatment | 2 weeks | To assess safety and tolerability of two weeks of digoxin therapy in the pre-surgical setting graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 4. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in HIF-1α Protein Expression | Baseline (biopsy prior to surgery) and at the end of 2 weeks digoxin treatment | Not enough tissue samples were collected to be analyzed and so no data was generated for this outcome measure. | ||
| SECONDARY | Number of Participants With Adverse Events With Digoxin Treatment | 2 weeks | Adverse events with digoxin is not applicable to the group no drug administration prior to surgery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events With Digoxin Treatment | Digoxin | 2 | Participants | ||
| Number of Participants With Adverse Events With Digoxin Treatment | No Drug Administration Prior to Surgery | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Digoxin | 2 | |
| Overall Study | STARTED | No Drug Administration Prior to Surgery | 4 | |
| Overall Study | COMPLETED | Digoxin | 2 | |
| Overall Study | COMPLETED | No Drug Administration Prior to Surgery | 3 | |
| Overall Study | NOT COMPLETED | Digoxin | 0 | |
| Overall Study | NOT COMPLETED | No Drug Administration Prior to Surgery | 1 |
Source ClinicalTrials.gov
Adverse events16
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 | Hip Pain | Musculoskeletal and connective tissue disorders | Digoxin | 1 | 2 | 1 |
| other | Hip Pain | Musculoskeletal and connective tissue disorders | No Drug Administration Prior to Surgery | 0 | 4 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Digoxin | 1 | 2 | 1 |
| other | Ear Pain | Ear and labyrinth disorders | No Drug Administration Prior to Surgery | 0 | 4 | 0 |
| other | Incisional pain | Surgical and medical procedures | Digoxin | 2 | 2 | 2 |
| other | Incisional pain | Surgical and medical procedures | No Drug Administration Prior to Surgery | 0 | 4 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Digoxin | 1 | 2 | 1 |
| other | Dry mouth | Gastrointestinal disorders | No Drug Administration Prior to Surgery | 0 | 4 | 0 |
| other | Increased urine output | Renal and urinary disorders | Digoxin | 1 | 2 | 1 |
| other | Increased urine output | Renal and urinary disorders | No Drug Administration Prior to Surgery | 0 | 4 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Digoxin | 0 | 2 |
| Total, all-cause mortality | No Drug Administration Prior to Surgery | 0 | 4 |
| Total, other adverse events | Digoxin | 2 | 2 |
| Total, other adverse events | No Drug Administration Prior to Surgery | 0 | 4 |
| Total, serious adverse events | Digoxin | 0 | 2 |
| Total, serious adverse events | No Drug Administration Prior to Surgery | 0 | 4 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Digoxin vs No Drug Administration Prior to Surgery: deaths from any cause | Trial comparisons |
| Digoxin vs No Drug Administration Prior to Surgery: serious adverse events | Trial comparisons |
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/NCT01763931
GET https://conductscience.org/api/trials/v1/NCT01763931/registered