Dapagliflozin for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and side effects of dapagliflozin, a medication typically used for diabetes and heart failure, when administered before surgery to patients with early-stage lung cancer (specifically stage IA lung adenocarcinoma). Researchers aim to determine if this drug can enhance surgical effectiveness by targeting a specific protein elevated in this cancer stage. Individuals diagnosed with stage IA lung adenocarcinoma and planning surgery may be suitable candidates for this trial. Participants will take dapagliflozin daily for 30 days and undergo tests, such as a biopsy and blood samples, to monitor progress. As an Early Phase 1 trial, this research seeks to understand how dapagliflozin functions in people with this type of cancer, offering a unique opportunity to contribute to groundbreaking medical knowledge.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are diabetic and on insulin or oral anti-diabetic drugs, your dose may be adjusted by the study's endocrinologists to prevent low blood sugar. If you are on systemic steroids or other investigational drugs, you may not be eligible to participate.
Is there any evidence suggesting that dapagliflozin is likely to be safe for humans?
Research has shown that dapagliflozin, a drug typically used for diabetes and heart failure, might also benefit lung cancer patients. Studies suggest that drugs like dapagliflozin are linked to a lower risk of developing lung cancer, which addresses safety concerns.
The FDA has already approved dapagliflozin for other health issues, indicating its general safety for those uses. Although the researchers are currently testing it for lung cancer, this background offers some reassurance about its safety. However, as this is an early phase trial, the full safety profile for lung cancer patients is still being explored.12345Why do researchers think this study treatment might be promising?
Unlike the standard chemotherapy and radiation treatments for lung cancer, dapagliflozin offers a fresh approach by targeting glucose transport in cancer cells. Originally used to manage diabetes, dapagliflozin works by inhibiting a protein responsible for glucose reabsorption in the kidneys, which could potentially starve cancer cells of the glucose they need to grow. Researchers are excited because this unique mechanism might slow down or stop tumor growth without the harsh side effects associated with traditional therapies. Additionally, as an oral medication, dapagliflozin offers a more convenient option compared to intravenous treatments, potentially improving the quality of life for patients.
What evidence suggests that dapagliflozin might be an effective treatment for stage IA lung adenocarcinoma?
Research has shown that dapagliflozin, an SGLT2 inhibitor, might reduce the risk of lung cancer. Some studies found that people taking SGLT2 inhibitors, such as dapagliflozin, had a lower chance of developing lung cancer compared to those using other treatments. Specifically, one study found a 13% lower risk of lung cancer for those on SGLT2 inhibitors. Additionally, lab experiments have shown that dapagliflozin can slow the growth of certain cancer cells. This trial will evaluate dapagliflozin's potential to improve outcomes for lung cancer patients, particularly those with early-stage tumors that have high levels of SGLT2 proteins.16789
Who Is on the Research Team?
Claudio Scafoglio, MD/PhD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Jane Yanagawa, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with early-stage lung adenocarcinoma (Stage IA). Participants should be candidates for surgery, and they must not have received any prior treatments for their cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dapagliflozin orally once daily for 30 days. Patients also undergo CT-guided biopsy and collection of blood and urine samples.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and tumor cell proliferation changes.
What Are the Treatments Tested in This Trial?
Interventions
- Dapagliflozin
Trial Overview
The trial is testing the safety of Dapagliflozin, a diabetes and heart failure medication, given before surgery to see if it can improve outcomes in lung cancer treatment. The study involves biospecimen collection, CT-assisted biopsy, and questionnaires.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive dapagliflozin PO QD for 30 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT-guided biopsy on study and collection of blood and urine samples throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Citations
Comparative risk of cancer associated with SGLT inhibitors ...
Subgroup analyses revealed significantly lower risks for liver (RR = 0.76), lung (RR = 0.87), and prostate (RR = 0.75) cancers with SGLT2i.
Unveiling the anticancer potential of SGLT-2 inhibitors
The study suggested that dapagliflozin may increase the overall risk of malignant tumors compared to other oral hypoglycemic agents, whereas ...
Exploring the Role of SGLT2 Inhibitors in Cancer
The addition of 2 months of oral dapagliflozin (10 mg/day) to GnP was well-tolerated. Of the 12 evaluable patients, 2 had a partial response (PR), 9 had stable ...
CENTER FOR DRUG EVALUATION AND RESEARCH
FARXIGA on CV outcomes (the DECLARE trial) support the conclusion that FARXIGA is also likely to be effective in patients with less advanced CKD ...
Dapagliflozin suppressed gastric cancer growth via ...
We found that Dapagliflozin (a SGLT2 inhibitor) could suppress gastric cancer cell proliferation and migration in vitro and tumor growth in vivo.
Testing the Safety of Dapagliflozin Prior to Surgery for ...
This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung ...
Sodium-glucose cotransporter 2 (SGLT2) inhibitors and ...
Our large SEER-Medicare linked data study indicates that SGLT2 inhibitors use was associated with improved overall survival of NSCLC patients with pre-existing ...
Sodium-glucose cotransporter-2 inhibitors and cancer ...
Conclusions. SGLT2 inhibitors are not associated with an increased risk of cancer outcomes, providing reassuring data regarding previous safety concerns.
SGLT2i and Primary Prevention of Cancer Therapy ...
SGLT2i administration was associated with a significantly decreased risk of developing CTRCD in patients with T2DM and cancer.
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