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Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

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ClinicalTrials.gov Identifier: NCT00090844
Recruitment Status : Terminated (Early closure due to low accrual)
First Posted : September 8, 2004
Results First Posted : January 21, 2013
Last Update Posted : January 31, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Hormone Changes
Drug Toxicity
Intervention: Drug: triptorelin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
49 female patients were enrolled between July 2003 and January 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Triptorelin

Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy

triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
no Triptorelin No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy

Participant Flow:   Overall Study
    Triptorelin   no Triptorelin
STARTED   27   22 
COMPLETED   26   21 
NOT COMPLETED   1   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Triptorelin GnRH analogue (triptorelin) during chemotherapy
no Triptorelin no GnRH analogue (triptorelin) during chemotherapy
Total Total of all reporting groups

Baseline Measures
   Triptorelin   no Triptorelin   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 27   22   49 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   27   22   49 
>=65 years   0   0   0 
Age 
[Units: Years]
Median (Full Range) 		 39 
 (21 to 44)  		 38 
 (26 to 44)  		 39 
 (21 to 44) 
Gender 
[Units: Participants]
 		     
Female   27   22   49 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 		     
Hispanic or Latino   3   2   5 
Not Hispanic or Latino   24   20   44 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
 		     
American Indian or Alaska Native   0   0   0 
Asian   0   2   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   2   1   3 
White   25   19   44 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
 		     
United States   27   22   49 


  Outcome Measures

1.  Primary:   Time to Resumption of Menses   [ Time Frame: Baseline, end of chemotherapy then 5 years ]
  Show Outcome Measure 1

2.  Secondary:   Chemotherapy-related Amenorrhea   [ Time Frame: Baseline, end of chemotherapy then 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years   [ Time Frame: Baseline, end of chemotherapy then 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years   [ Time Frame: Baseline, through chemotherapy then 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years   [ Time Frame: 5 years after end of chemotherapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Triptorelin

GnRH analogue (triptorelin) during chemotherapy

triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
no Triptorelin No GnRH analogue (triptorelin) during chemotherapy

Other Adverse Events
    Triptorelin   no Triptorelin
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   25/27 (92.59%)   18/22 (81.82%) 
Blood and lymphatic system disorders     
Edema - limb †     
# participants affected / at risk   1/27 (3.70%)   2/22 (9.09%) 
# events   1   3 
Endocrine disorders     
hot flashes/flushes †     
# participants affected / at risk   23/27 (85.19%)   12/22 (54.55%) 
# events   38   18 
Gastrointestinal disorders     
Constipation †     
# participants affected / at risk   4/27 (14.81%)   2/22 (9.09%) 
# events   5   3 
Distension/bloating, abdominal †     
# participants affected / at risk   3/27 (11.11%)   1/22 (4.55%) 
# events   3   1 
Heartburn/dyspepsia †     
# participants affected / at risk   1/27 (3.70%)   3/22 (13.64%) 
# events   2   5 
Mucositis/stomatitis (clinical exam) †     
# participants affected / at risk   2/27 (7.41%)   1/22 (4.55%) 
# events   2   1 
Nausea †     
# participants affected / at risk   6/27 (22.22%)   7/22 (31.82%) 
# events   8   14 
Vomiting †     
# participants affected / at risk   2/27 (7.41%)   2/22 (9.09%) 
# events   2   2 
Mucositis/stomatitis (NOS) †     
# participants affected / at risk   0/27 (0.00%)   2/22 (9.09%) 
# events   0   2 
General disorders     
Fatigue †     
# participants affected / at risk   4/27 (14.81%)   1/22 (4.55%) 
# events   5   1 
Insomnia †     
# participants affected / at risk   3/27 (11.11%)   2/22 (9.09%) 
# events   3   2 
Sweating (diaphoresis) †     
# participants affected / at risk   4/27 (14.81%)   5/22 (22.73%) 
# events   4   6 
Weight gain †     
# participants affected / at risk   3/27 (11.11%)   1/22 (4.55%) 
# events   3   1 
Pain †     
# participants affected / at risk   10/27 (37.04%)   7/22 (31.82%) 
# events   31   16 
Headaches †     
# participants affected / at risk   6/27 (22.22%)   5/22 (22.73%) 
# events   13   5 
Pain - Other †     
# participants affected / at risk   2/27 (7.41%)   2/22 (9.09%) 
# events   2   2 
Infections and infestations     
Infection - Other †     
# participants affected / at risk   2/27 (7.41%)   2/22 (9.09%) 
# events   2   2 
Infection with unknown ANC †     
# participants affected / at risk   4/27 (14.81%)   4/22 (18.18%) 
# events   6   5 
Metabolism and nutrition disorders     
ALT, SGPT (serum glutamic pyruvic transaminase) †     
# participants affected / at risk   6/27 (22.22%)   5/22 (22.73%) 
# events   7   5 
AST, SGOT (serum glutamic oxaloacetic transaminase) †     
# participants affected / at risk   3/27 (11.11%)   3/22 (13.64%) 
# events   4   3 
Alkaline phosphatase †     
# participants affected / at risk   2/27 (7.41%)   0/22 (0.00%) 
# events   4   0 
Glucose, serum-high (hyperglycemia) †     
# participants affected / at risk   9/27 (33.33%)   8/22 (36.36%) 
# events   22   14 
Metabolic/Laboratory - Other †     
# participants affected / at risk   6/27 (22.22%)   0/22 (0.00%) 
# events   10   0 
Potassium, serum-low (hypokalemia) †     
# participants affected / at risk   3/27 (11.11%)   1/22 (4.55%) 
# events   3   1 
Nervous system disorders     
Mood alteration †     
# participants affected / at risk   13/27 (48.15%)   6/22 (27.27%) 
# events   15   8 
Neuropathy: sensory †     
# participants affected / at risk   2/27 (7.41%)   2/22 (9.09%) 
# events   2   2 
Reproductive system and breast disorders     
Vaginal dryness †     
# participants affected / at risk   3/27 (11.11%)   0/22 (0.00%) 
# events   3   0 
Vaginal discharge (non-infectious) †     
# participants affected / at risk   2/27 (7.41%)   0/22 (0.00%) 
# events   2   0 
Respiratory, thoracic and mediastinal disorders     
Cough †     
# participants affected / at risk   2/27 (7.41%)   0/22 (0.00%) 
# events   2   0 
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other †     
# participants affected / at risk   3/27 (11.11%)   1/22 (4.55%) 
# events   4   1 
Hair loss/alopecia (scalp or body) †     
# participants affected / at risk   11/27 (40.74%)   7/22 (31.82%) 
# events   11   7 
Ulceration †     
# participants affected / at risk   0/27 (0.00%)   2/22 (9.09%) 
# events   0   2 
† Events were collected by systematic assessment



  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study closed to accrual early due to futility


  More Information