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
Trial Overview
The trial is testing Venlafaxine as a way to reduce anxiety, depression, and pain in patients undergoing treatment for head and neck cancer. It aims to establish a protocol for early pharmacotherapy in these patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Starting dose of oral venlafaxine immediate release (IR) 37.5 mg BID, to be taken with food. The dosing will be increased at a rate of 75mg per week for 3 weeks, to reach a desired dose of 300mg per day, taken as 150mg BID. For patients with hepatic impairment, severe renal impairment, or end-stage kidney disease, the starting dose is 37.5 mg once daily, and the dose is increased by increments of 37.5 mg per day, to a maximum of 187.5 mg per day, taken as 93.75 mg BID.
No intervention will be provided for this group
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
Citations
Efficacy comparison of five antidepressants in treating anxiety ...
The efficacy of escitalopram is comparable to duloxetine, venlafaxine, and vortioxetine, all of which outperformed sertraline in cancer patients.
2.
trial.medpath.com
trial.medpath.com/clinical-trial/bf66fdfe340519c3/nct05724849-venlafaxine-prevention-depression-head-neck-cancerVenlafaxine for the Prevention of Depression in Patients With ...
The investigators hypothesize that venlafaxine will provide mood stabilization and improved pain control in patients undergoing surgical treatment for HNC. The ...
Antidepressants for the treatment of depression in people with ...
The meta‐analysis showed an improvement in depressive symptoms in patients treated with antidepressants, with an overall risk ratio of 1.56 (95% ...
A systematic review of pharmacologic treatment efficacy for ...
The objective of this investigation was to review what is known about the efficacy of pharmacologic treatment for older adults with depression and cancer.
5.
cancernetwork.com
cancernetwork.com/view/antidepressants-patients-advanced-cancer-when-theyre-warranted-and-how-choose-therapyAntidepressants in Patients With Advanced Cancer
In this article, we discuss the importance of screening for depression in cancer patients, as well as the available treatment options and their pros and cons.
Venlafaxine (oral route) - Side effects & dosage
Check with your doctor right away if you have a headache, trouble concentrating, memory problems, confusion, weakness, or feel unsteady when ...
Mood Disorders in Head and Neck Cancer Patients | ...
Treatment Group: Participants will be prescribed a starting dose of venlafaxine immediate release (IR) 37.5 mg twice daily. The IR formulation was selected due ...
Effexor XR (venlafaxine hydrochloride) Extended-Release ...
The safety and efficacy of. Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response ...
Venlafaxine (Effexor) - Uses, Side Effects, and More
What are the serious side effects of venlafaxine? · Sudden severe headache · Chest pain · Dizziness or confusion · Trouble breathing · Nausea/ ...
Venlafaxine Side Effects: Common, Severe, Long Term
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies.
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