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Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"

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ClinicalTrials.gov Identifier: NCT02134977
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date April 23, 2014
First Posted Date May 9, 2014
Results First Submitted Date August 24, 2016
Results First Posted Date October 18, 2016
Last Update Posted Date October 18, 2016
Study Start Date September 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2016)
  • Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline [ Time Frame: Baseline ]
    QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.
  • QOL-ACD Total and Subscale Score at Week 12 [ Time Frame: Week 12 ]
    QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale:5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.
  • QOL-ACD Total and Subscale Score at Week 48 [ Time Frame: Week 48 ]
    QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.
  • QOL-ACD Breast (QOL-ACD-B) Score at Baseline [ Time Frame: Baseline ]
    QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score was calculated over score range 0-100 for item 1 to 18 as ((a sum of 18 items)/18-1)*25). Score for physical condition and pain was calculated over score range 0-100 for item 1 to 6 as ((a sum of 6 items)/6-1)*25)). Score for health-care and illness satisfaction was calculated over score range 0-100 for item 7 to 10 as ((a sum of 4 items)/4-1)*25)), where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.
  • Score of QOL-ACD-B at Week 12 [ Time Frame: Week 12 ]
    QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.
  • Score of QOL-ACD-B at Week 48 [ Time Frame: Week 48 ]
    QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.
  • Score of QOL-ACD-B Items 19, 20 and 21 at Baseline [ Time Frame: Baseline ]
    QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.
  • Score of QOL-ACD-B Items 19, 20 and 21 at Week 12 [ Time Frame: Week 12 ]
    QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.
  • Score of QOL-ACD-B Items 19, 20 and 21 at Week 48 [ Time Frame: Week 48 ]
    QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.
Original Primary Outcome Measures
 (submitted: May 7, 2014)
Changes in QOL [ Time Frame: From baseline to 48 weeks of treatment ]
For the efficacy analysis set, the following parameters will be tabulated: changes in QOL (QOL-ACD score, QOL-ACD-B score, patient impression to switching medication) from baseline to 48 weeks of treatment will be tabulated.
Change History
Current Secondary Outcome Measures
 (submitted: August 24, 2016)
  • Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents [ Time Frame: Week 48 ]
    The question was with regard to the assessment of convenience associated with the changes in agents, "Did the change in agents reduce the frequency of your medical visits?" and the answers were categorized as very much reduced, somewhat reduced, unchanged. Change in medicinal agents means participants with a historical diagnosis of premenopausal breast cancer who switched to leuprorelin acetate sustained-release 11.25 mg injection kit from a 4-week adjuvant therapy with a LH-RHa 1 month depot preparation as part of daily medical practice.
  • Percentage of Participants Who Felt Relief From Physical and Emotional Burden [ Time Frame: Week 48 ]
    The question was with regard to the assessment of convenience associated with the changes in agents, "The change in agents reduced the frequency of injections by one third; for this reason, did you feel relief from physical and emotional burden?" and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief.
  • Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents [ Time Frame: Week 48 ]
    The question was with regard to the assessment of convenience associated with the changes in agents, "Did you feel relief from financial burden (example, 3 months' drug costs and transportation fee) due to the change in agents?" and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief. The sum of all the categories is not 100% because of rounding error.
  • Percentage of Participants Who Worried About the Effect of the Medicinal Agent [ Time Frame: Week 48 ]
    The question was with regard to the assessment of convenience associated with the changes in agents, "The change in agents reduced the frequency of injections by one third; for this reason, did you worry about the effect?" and the options of the answers were not at all worried, not too worried, no thought either way, somewhat worried, and very worried.
  • Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents [ Time Frame: Week 48 ]
    The question was with regard to the assessment of convenience associated with the changes in agents, "Was there a change in adverse drug reactions (e.g., menopausal-like symptoms such as hot flushes, injection-site abnormalities) due to the change in agents?" and the options of the answers were events became much less severe, events became less severe, whether or not the events became severe cannot be determined, events became slightly more severe, and events became very severe.
  • Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents [ Time Frame: Week 48 ]
    The question was with regard to the assessment of convenience associated with the changes in agents, "Was there a change in pain at the time of injection due to the change in agents?" and the options of the answers were significantly relieved, slightly relieved, whether or not the pain worsened or was relieved cannot be determined, worsened slightly, and worsened significantly.
  • Percentage of Participants With Positive Change in Agents [ Time Frame: Week 48 ]
    The question was with regard to the assessment of convenience associated with the changes in agents, "Was the change in agents good?" and the options of the answers were very good, somewhat good, whether or not the change in agents was good cannot be determined, somewhat bad, very bad.
  • Number of Participants Reporting One or More Adverse Drug Reactions [ Time Frame: Baseline up to Week 48 ]
    Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
  • Number of Participants Reporting One or More Serious Adverse Drug Reactions [ Time Frame: Baseline up to Week 48 ]
    Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event was occurred in breast cancer female.
Original Secondary Outcome Measures
 (submitted: May 7, 2014)
Frequency of adverse drug reactions [ Time Frame: For 48 weeks ]
The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of leuprorelin acetate whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with leuprorelin acetate are defined as adverse drug reactions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
Official Title Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
Brief Summary The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice. Influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit was also evaluated.
Detailed Description

This survey was designed to examine the effect on QOL improvement and convenience of switching to leuprorelin acetate 3 month depot 11.25 mg injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a LH-RHa 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice, as well as to evaluate the influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit .

For adults, leuprorelin acetate SR 11.25 mg injection kit (Leuplin SR 11.25 mg Injection Kit) is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Breast cancer
Condition Breast Cancer
Intervention Drug: Leuprorelin Acetate
Leuprorelin Acetate SR 11.25 mg Injection Kit
Other Name: Leuplin SR 11.25 mg Injection Kit
Study Groups/Cohorts Leuprorelin Acetate
Subcutaneous administration of leuprorelin acetate 11.25 mg once every 12 weeks
Intervention: Drug: Leuprorelin Acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2014)
2816
Original Actual Enrollment Same as current
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Premenopausal breast cancer participants who meet all the following criteria are to be enrolled in the surveillance:

    1. Participants who received 4 weeks of treatment with a repository LH-RHa preparation within 1 week prior to administration of Leuplin SR 11.25 mg Injection Kit.
    2. Participants receiving Leuplin SR 11.25 mg Injection Kit as adjuvant therapy.
    3. Participants with performance status grade of 0 or 1.
    4. Participants who answered all of the questions on the "QOL check sheet (I)" at the start (Week 0) of treatment with Leuplin SR 11.25 mg Injection Kit.

Exclusion Criteria:

  • Participants who meet any of the following criteria are to be excluded from the surveillance:

    1. Participants with a history of hypersensitivity to ingredient(s) in Leuplin SR 11.25 mg Injection Kit or synthetic derivatives of luteinizing hormone-releasing hormone (LH-RH) or LH-RH.
    2. Pregnant women, possibly pregnant women, and nursing mothers.
    3. Participants with advanced (T4 or M1 according to the TNM classification [General Rules for Clinical and Pathological Recording of Breast Cancer: 16th edition]) or recurrent breast cancer.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02134977
Other Study ID Numbers 265-211
JapicCTI-142513 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Chair: Postmarketing Group Manager Takeda
PRS Account Takeda
Verification Date August 2016