Trial Outcomes & Findings for DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer (NCT NCT00972023)
NCT ID: NCT00972023
Last Updated: 2019-09-17
Results Overview
TERMINATED
PHASE1
1 participants
Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
2019-09-17
Participant Flow
Cancer center clinic
Participant milestones
| Measure |
DHEA, Surgical Resection
DHEA, surgical resection:
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA: Administration will begin approxiately 14 days prior to surgery.
Surgical resection: Surgical procedure of the invasive breast cancer
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
DHEA, Surgical Resection
DHEA, surgical resection:
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA: Administration will begin approxiately 14 days prior to surgery.
Surgical resection: Surgical procedure of the invasive breast cancer
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
Baseline characteristics by cohort
| Measure |
DHEA, Surgical Resection
n=1 Participants
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA : DHEA administration will begin approxiately 14 days prior to surgery.
Surgical resection : Surgical procedure of the invasive breast cancer
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.Population: Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery \& refused follow up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.Population: Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery \& refused follow up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.Population: Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery \& refused follow up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 48 hours prior to surgery and after 14 days of DHEA treatment.Population: Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery \& refused follow up.
Outcome measures
Outcome data not reported
Adverse Events
DHEA, Surgical Resection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place