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

This study has been terminated.
(Early closure due to low accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00090844
First received: September 7, 2004
Last updated: January 23, 2013
Last verified: January 2013
Results First Received: November 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Hormone Changes
Drug Toxicity
Intervention: Drug: triptorelin

  Participant Flow
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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


  Outcome Measures

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

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

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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
  Hide 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
  Hide 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