Venlafaxine for Depression in Head and Neck Cancer Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the medication venlafaxine, an antidepressant, can reduce anxiety, depression, and pain in individuals newly diagnosed with head and neck cancer. It targets those about to begin cancer treatment and who may face these emotional and physical challenges. Participants will either receive venlafaxine or join a group that does not receive the medication. Suitable candidates include those with a new cancer diagnosis, planning to start treatment, and not currently taking medication for depression or anxiety. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective venlafaxine can benefit more patients.
Will I have to stop taking my current medications?
If you are currently taking medication for depression or anxiety, you will need to stop, as the trial excludes those already receiving such treatments.
What is the safety track record for Venlafaxine?
Research shows that venlafaxine, the treatment under study, is usually well-tolerated by most people. However, some side effects have been reported. Common ones include nausea, dizziness, and headaches. More serious side effects, though less common, can include severe headaches, chest pain, and trouble breathing.
The FDA has already approved venlafaxine for treating depression, indicating that its safety is well understood. This helps doctors anticipate how people might react to it. An increased risk of suicidal thoughts exists in young adults, mainly seen in short-term studies. In this study, participants will start with a low dose that gradually increases to help manage side effects.
Prospective trial participants should discuss any concerns with their doctor, especially if they have existing health issues like liver or kidney problems.12345Why are researchers enthusiastic about this study treatment?
Venlafaxine is unique because it targets depression in head and neck cancer patients, a group often underserved by standard antidepressants like SSRIs (Selective Serotonin Reuptake Inhibitors). This medication belongs to a class called SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), which may offer a more balanced approach by acting on two neurotransmitters instead of just one. Researchers are excited because venlafaxine has the potential to better address the complex mood issues faced by these patients, possibly leading to improved quality of life alongside cancer treatment.
What is the effectiveness track record for Venlafaxine in treating depression in head and neck cancer patients?
Research has shown that venlafaxine, which participants in this trial may receive, effectively treats depression in cancer patients. Studies have found that venlafaxine works well compared to other antidepressants, such as escitalopram and duloxetine, especially for cancer patients. One analysis found that antidepressants improved symptoms of depression and significantly stabilized mood. Additionally, venlafaxine may help manage pain, which is important for those undergoing cancer treatment. Overall, venlafaxine has proven to be a reliable option for treating depression in patients with head and neck cancer.678910
Who Is on the Research Team?
Jessica Grayson, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults over 18 with newly diagnosed head and neck cancer who are about to start treatment. They must be able to take oral medication, speak English, and commit to the study's duration. Pregnant or nursing women, those on current depression/anxiety meds, with certain thyroid cancers or severe mental health conditions can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the treatment group receive venlafaxine with dose titration over 3 weeks, while the control group receives no pharmacological treatment
Initial Follow-up
Participants follow up 6-8 weeks after beginning their chosen treatment regimen for head and neck cancer, completing study questionnaires and vital sign collection
Extended Follow-up
Participants are monitored every three months for up to one year, with vital signs, concomitant medications, adverse events, and questionnaire responses collected
What Are the Treatments Tested in This Trial?
Interventions
- Venlafaxine
Venlafaxine is already approved in European Union, United States, Canada for the following indications:
- Major depressive disorder
- Generalized anxiety disorder
- Social anxiety disorder
- Panic disorder
- Major depressive disorder
- Generalized anxiety disorder
- Social anxiety disorder
- Panic disorder
- Major depressive disorder
- Generalized anxiety disorder
- Social anxiety disorder
- Panic disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor