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

NCT02134977 | Completed Results

• 2 other identifiers: 265-211JapicCTI-142513
• Study Type: observational
• Target: 2,816
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (9)

• Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at 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.

  Baseline

• QOL-ACD Total and Subscale Score at 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.

  Week 12

• QOL-ACD Total and Subscale Score at 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.

  Week 48

• QOL-ACD Breast (QOL-ACD-B) Score at 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.

  Baseline

• Score of QOL-ACD-B at 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.

  Week 12

• Score of QOL-ACD-B at 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.

  Week 48

• Score of QOL-ACD-B Items 19, 20 and 21 at 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.

  Baseline

• Score of QOL-ACD-B Items 19, 20 and 21 at 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.

  Week 12

• Score of QOL-ACD-B Items 19, 20 and 21 at 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.

  Week 48

Secondary Outcomes (9)

• Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents

  Week 48

• Percentage of Participants Who Felt Relief From Physical and Emotional Burden

  Week 48

• Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents

  Week 48

• Percentage of Participants Who Worried About the Effect of the Medicinal Agent

  Week 48

• Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents

  Week 48

Study Arms (1)

Leuprorelin Acetate

Subcutaneous administration of leuprorelin acetate 11.25 mg once every 12 weeks

Drug: Leuprorelin Acetate

Interventions

Leuprorelin Acetate DRUG

Leuprorelin Acetate SR 11.25 mg Injection Kit

Also known as: Leuplin SR 11.25 mg Injection Kit

Leuprorelin Acetate

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer

You may qualify if:

• Premenopausal breast cancer participants who meet all the following criteria are to be enrolled in the surveillance:
• 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.
• Participants receiving Leuplin SR 11.25 mg Injection Kit as adjuvant therapy.
• Participants with performance status grade of 0 or 1.
• 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.

You may not qualify if:

• Participants who meet any of the following criteria are to be excluded from the surveillance:
• 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.
• Pregnant women, possibly pregnant women, and nursing mothers.
• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: May 9, 2014
• Study Start: September 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 18, 2016
• Results First Posted: October 18, 2016

Record last verified: 2016-08