Depression, Head and Neck Cancer
Conditions
Brief summary
This is a pilot double-blinded, randomized, placebo-controlled trial to determine if venlafaxine prevents depression in patients undergoing surgery for Head and Neck Cancer (HNC).
Detailed description
Patients with head and neck cancer (HNC) are disproportionately affected by major depressive disorder (MDD), with up to 50% developing MDD compared to 15-25% of patients with other solid malignancies. The higher rates of depression seen in HNC patients are likely related to treatment-associated disfigurement, voice and swallow dysfunction, and other physical alterations that significantly diminish quality of life. Survivors of HNC have a significantly increased risk of suicide when compared to other cancers. The rate of suicide among HNC survivors is 63.4 suicides per 100,000 person-years, which is three times that of other cancer survivors and second highest only behind pancreatic cancer. There is evidence to suggest that depression plays a role in HNC prognosis, with studies showing a 25% decrease in overall survival in HNC patients with depression. Despite the prevalence and impact of depression in HNC patients, there has only been one randomized control trial to prevent depression in patients with HNC that showed potential benefit. This study used escitalopram, a selective-serotonin reuptake inhibitor (SSRI). A more appropriate medication would be one that provided mood stabilization as well as pain modulation, since it is known that HNC treatment can lead to long-term opioid use. Serotonin-norepinephrine reuptake inhibitors (SNRIs) provide dual action against serotonergic and noradrenergic receptors and have shown to provide superior pain relief than monoaminergic drugs such as SSRIs. The investigators hypothesize that venlafaxine will provide mood stabilization and improved pain control in patients undergoing surgical treatment for HNC. The investigators plan to conduct a pilot double-blinded, randomized, placebo-controlled trial using venlafaxine in HNC patients treated with surgery. Patients who screen negative for Bipolar disorder (BPD) based on the screening tool The Mood Disorder Questionnaire (MDQ) as well as for MDD using the Patient Health Questionnaire (PHQ-9) preoperatively (Cohort A) will be randomized to either venlafaxine or placebo and will be assessed throughout the perioperative period with a series of validated self-reported questionnaires regarding depression, anxiety, pain, and other quality of life measures.
Interventions
DRUGVenlafaxine
See arm/group description.
DRUGPlacebo
See arm/group description.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
COHORT A (RCT) 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Have a recently diagnosed cutaneous or mucosal malignancy 5. Scheduled to undergo surgical treatment for their malignancy with curative intent 6. Ability to take medication orally or via gastric tube feeds 7. Willing to adhere to the study drug's dosing protocol 8. Score \<10 on the PHQ-9 COHORT B (Observation cohort) 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Have a recently diagnosed cutaneous or mucosal malignancy 5. Scheduled to undergo surgical treatment for their malignancy with curative intent 6. Ability to take medication orally or via gastric tube feeds 7. Willing to adhere to the study drug's dosing protocol 8. Score \>10 on the PHQ-9
Exclusion criteria
COHORT A (RCT) 1. Score \>10 on PHQ-9 2. Score between 5-9 on PHQ-9 and elect for psychotherapy 3. Age less than 18 years 4. Primary malignancy of thyroid or parathyroid origin 5. Currently meet diagnostic criteria for psychosis, schizophrenia, or bipolar disorder 6. Currently receiving medication as treatment for depression or anxiety including: MAO inhibitors, Linezolid, Other SNRIs or SSRIs, Bupropion 7. Known allergic reaction to components of study drug 8. Treatment with another investigational drug or other intervention within 30 days 9. Females of child-bearing age who are pregnant or nursing 10. Inability to speak or understand English COHORT B (Observation cohort) 1. Score \<10 on PHQ-9 2. Unwillingness or inability to take venlafaxine 3. Age less than 18 years 4. Primary malignancy of thyroid or parathyroid origin 5. Currently receiving medication as treatment for depression or anxiety including: MAO inhibitors, Linezolid, Other SNRIs or SSRIs, Bupropion 7\. Known allergic reaction to components of study drug 8. Treatment with another investigational drug or other intervention within 30 days 9. Females of child-bearing age who are pregnant or nursing 10. Inability to speak or understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Depression | 4 months post-operatively | Rate of depression at any time interval within the 4-month post-surgery period in patients with no or mild MDD. This will be assessed using the Patient-Health Questionnaire (PHQ-9) which is scored ranging from 0-27 with a higher score indicating more severe depression. Four months was chosen as the duration to capture the adjuvant radiation period, which is typically 3 months post-surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment of Depression | 4 months post-operatively | Rate of depression at 4 months post-surgery in patients who initially screened positive for moderate, moderately-severe, or severe MDD. This will be assessed using the Patient-Health Questionnaire (PHQ-9) which is scored ranging from 0-27 with a higher score indicating more severe depression. |
| Prevention of Anxiety | 4 months post-operatively | Rate of anxiety at 4-months post-surgery in all patients enrolled. This will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) which reports scores on a scale, ranging from 0 to 21 with higher scores indicating worse outcomes. |
| Prevention of Pain | 4 months post-operatively | Rate of pain control at 4-months post-surgery in all patients enrolled. This will be assessed using the Brief Pain Inventory-short form which is scored on a scale of 0 to 10 with a higher score indicating a worse outcome. |
| Quality of Life Improvement | 4 months post-operatively | Quality of life at 4 months post-surgery in all patients enrolled. This will be assessed using the FACE-Q HNC which is scored on a scale. The scale ranges from 0 to 100 with a higher score meaning a better outcome. |
Outcome results
None listed