Phentermine-Topiramate ER for Obesity in Cancer Survivors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the weight-loss medication Phentermine-Topiramate ER, combined with healthy lifestyle counseling, can safely reduce obesity in young cancer survivors, such as those who have had leukemia or lymphoma. Participants will receive either the medication plus counseling or just the counseling for 24 weeks. This trial suits individuals aged 12 to 24 who are in remission from these cancers, have completed treatment, and are managing obesity. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of phentermine and topiramate extended release (PHEN/TOP) is generally well-tolerated. This treatment, designed to aid weight loss, has already received FDA approval for obesity. Studies have found that it can help people lose a significant amount of weight.
However, some individuals have experienced side effects related to the nervous system, such as tingling or dizziness. While PHEN/TOP is generally safe, researchers continue to collect long-term safety data. Prospective trial participants should discuss any concerns with the trial team.12345Why do researchers think this study treatment might be promising for obesity?
Researchers are excited about the phentermine-topiramate extended-release treatment for obesity in cancer survivors because it combines two active ingredients, phentermine and topiramate, which work together to promote weight loss. Unlike standard treatments that often focus solely on lifestyle changes or single medications, this combination targets both appetite suppression and increased energy expenditure. Additionally, the extended-release formula allows for once-daily dosing, which can improve patient adherence compared to treatments requiring multiple doses throughout the day.
What evidence suggests that this trial's treatments could be effective for obesity in cancer survivors?
Research has shown that the medication phentermine/topiramate ER, which participants in this trial may receive, can help reduce obesity. Studies have found that people using this treatment can lose up to 13% of their body weight. In other research, about 75% of patients lost at least 5% of their weight, which is important for improving health. Participants also experienced smaller waist sizes and lower blood pressure, blood sugar, and cholesterol levels. Most people tolerated the treatment well, with manageable side effects. This trial will compare the effectiveness of phentermine/topiramate ER combined with health behavior and lifestyle counseling to health behavior and lifestyle counseling alone, offering a promising option for those looking to manage their weight effectively.46789
Who Is on the Research Team?
Stephanie Dixon, MD, MPH
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for adolescents and young adults (ages 12-24) who are in remission from leukemia or lymphoma, have obesity, finished all major cancer treatments, and do not have diabetes needing medication, uncontrolled blood pressure or heart issues. Participants must be able to swallow pills and agree to contraception if female.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either PHEN/TOP plus counseling or counseling alone for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with an observational follow-up visit at week 52
What Are the Treatments Tested in This Trial?
Interventions
- Health Behavior and Lifestyle Counseling
- Phentermine/Topiramate ER
Trial Overview
The study compares a weight-loss drug (phentermine/topiramate ER) plus healthy lifestyle counseling versus counseling alone in young people who survived leukemia or lymphoma. Participants are randomly assigned to one of the two groups for 24 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive phentermine-topiramate extended-release orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines, plus health behavior and lifestyle counseling every 4 weeks.
Participants receive standard health behavior and lifestyle counseling every 4 weeks for 24 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
Citations
1.
researchgate.net
researchgate.net/publication/346440177_Efficacy_and_safety_of_phenterminetopiramate_in_adults_with_overweight_or_obesity_A_meta-analysis_and_systematic_reviewEfficacy and safety of phentermine/topiramate in adults with ...
Phentermine/topiramate reduced waist circumference, blood pressure, blood sugar levels, and lipid levels. The adverse effects associated with ...
Phentermine-Topiramate + Lifestyle Intervention for Obesity
One study found that this treatment helped patients with obesity lose up to 13% of their body weight. Most people tolerated the treatment well. However, some ...
Phentermine-topiramate extended release for the dual ...
Weight loss at 5 months of 5% was modest, but this is considered clinically meaningful because many comorbidities are improved with this degree ...
Evaluation of phentermine and topiramate versus ... - HERO
The percentage of subjects achieving ≥5% WL was 15.5% for placebo, 43.3% for phentermine 7.5, 46.2% for phentermine 15, 39.2% for topiramate ER 46, 48.6% for ...
A randomized, placebo-controlled, phase 3 extension study
PHEN/TPM CR in conjunction with lifestyle modification may provide a well-tolerated and effective option for the sustained treatment of obesity ...
Efficacy and safety of phentermine/topiramate in adults with ...
Phentermine/topiramate reduced body weight and was well tolerated. However, it increased the risk of nervous system-related adverse events to a ...
Clinical utility of phentermine/topiramate (Qsymia™) ...
controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients.
8.
go.drugbank.com
go.drugbank.com/drugs/DB00191/clinical_trials?phase=4&status=completed&purpose=treatment&conditions=DBCOND0015947Phentermine Completed Phase 4 Trials for Obesity Treatment
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker. Phentermine (DB00191) ...
Efficacy and safety of phentermine/topiramate in adults with ...
Phentermine/topiramate was approved by the FDA as an anti-obesity drug. · Phentermine/topiramate reduced body weight and was well tolerated.
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