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The Clinical Study of Metformin in Ovarian Reserve and Function Protection for Breast Cancer Survivors Treated with Chemotherapy

The Protection Role of Metformin in Ovarian Reserve and Function for Breast Cancer Survivors Treated with Chemotherapy: A Double-Blind, Randomized, Placebo-Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023487
Enrollment
Unknown
Registered
2019-05-31
Start date
2019-10-22
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer patients

Interventions

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Premenopausal women aged 18-45 years old; 2) Breast cancer staging: patients receiving adjuvant/neoadjuvant chemotherapy in stage I-IIIa; 3) Assessment of normal ovarian function before chemotherapy (regular menstruation or active 6 weeks before chemotherapy); 4) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who have received chemotherapy and pelvic area radiotherapy before; 2) Combine endocrine diseases (such as PCOS, hyperprolactinemia, hyperandremia, adrenal dysfunction, etc.) that affect ovarian function; 3) Combine cardiovascular, liver, kidney, infectious diseases, hematopoietic system and other serious diseases, with a history of lactic acidosis or high risk factors; 4) distant metastasis of breast cancer; 5) pregnant or lactating women; 6) A history of diabetes is currently taking any hypoglycemic agent; 7) known to be allergic to metformin hydrochloride and its analogues; 8) Patients who are participating in or have participated in other clinical trials in the past 3 months; 9) oral contraceptives or hormonal drugs during the trial; 10) Other patients identified by the investigator as unfit for the study;

Design outcomes

Primary

MeasureTime frame
Menstruation recovery rate;disease-free survival (DFS);

Secondary

MeasureTime frame
Sex hormones+AMH+InhibinB;5-year pregnancy outcome;Tumor prognosis;The quality of patient's life;Safety assessment;

Countries

China

Contacts

Public ContactShixuan Wang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

sxwang@tjh.tjmu.edu.cn+86 27 83663180

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026