Head and Neck CancerPhase 2NCT05724849
Venlafaxine for the Prevention of Depression in Patients With Head and Neck Cancer
A Phase 2 study testing Venlafaxine in people with Head and Neck Cancer and Depression, run by Vanderbilt University Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Depression
- What is being tested?
- Venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COHORT A (RCT)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- Have a recently diagnosed cutaneous or mucosal malignancy
- Scheduled to undergo surgical treatment for their malignancy with curative intent
Show all 18Show fewer
- Ability to take medication orally or via gastric tube feeds
- Willing to adhere to the study drug's dosing protocol
- Score <10 on the PHQ-9
- COHORT B (Observation cohort)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- Have a recently diagnosed cutaneous or mucosal malignancy
- Scheduled to undergo surgical treatment for their malignancy with curative intent
- Ability to take medication orally or via gastric tube feeds
- Willing to adhere to the study drug's dosing protocol
- Score >10 on the PHQ-9
Who cannot join
- COHORT A (RCT)
- Score >10 on PHQ-9
- Score between 5-9 on PHQ-9 and elect for psychotherapy
- Age less than 18 years
- Primary malignancy of thyroid or parathyroid origin
- Currently meet diagnostic criteria for psychosis, schizophrenia, or bipolar disorder
Show all 18Show fewer
- Currently receiving medication as treatment for depression or anxiety including: MAO inhibitors, Linezolid, Other SNRIs or SSRIs, Bupropion
- Known allergic reaction to components of study drug
- Treatment with another investigational drug or other intervention within 30 days
- Females of child-bearing age who are pregnant or nursing
- Inability to speak or understand English
- COHORT B (Observation cohort)
- Score <10 on PHQ-9
- Unwillingness or inability to take venlafaxine
- Age less than 18 years
- Primary malignancy of thyroid or parathyroid origin
- 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
About this study
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).
Read the 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.
- Conditions
- Head and Neck Cancer, Depression
- Being tested
- Venlafaxine, Placebo
- Medical subject headings
- Head and Neck Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Effexor
See arm/group description.
PlaceboDrug
See arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Venlafaxine | Experimental | Patients who screen negative or meet criteria for mild MDD are eligible for the randomized control trial (RCT) portion of this study in which patients are randomized into either the intervention (venlafaxine) arm or placebo. Participants randomized into the intervention group will be prescribed a starting dose of venlafaxine immediate release (IR) 75mg once daily. The dosing will be increased at the following rate:
Week 1: 75mg in AM
Week 2: 75mg BID
Week 3: 150mg in AM, 75mg in PM
Week 4: 150mg BID
For patients with hepatic impairment, severe renal impairment, or end stage kidney disease, the starting dose is 37.5 mg once daily, increased by increments of 37.5 mg per day to reach a maximum of 187.5 mg per day, given in two divided doses. Receives: Drug: Venlafaxine |
| Placebo | Placebo comparator | Patients who screen negative or meet criteria for mild MDD are eligible for the randomized control trial (RCT) portion of this study in which patients are randomized into either the intervention (venlafaxine) arm or placebo. Participants randomized to the placebo group will receive a placebo capsule with the same dosing schedule as the intervention group. Receives: Drug: Placebo |
| Observation | Other | Patients who screen positive for moderate, moderately-severe, or severe MDD are excluded from the RCT and will be enrolled in the study as an observation cohort. These patients will be offered initiation of venlafaxine and will be referred to our collaborating oncologic psychiatrist. Patients in cohort B will still complete the same patient-reported outcome measures (PROMs) as patients in cohort A, allowing us to collect data and better understand what effects venlafaxine has on patients who are already diagnosed with depression at the start of treatment for HNC. Receives: Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Depression
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.
Measured: 4 months post-operatively
Secondary outcomes (5)
Treatment of Depression
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.
Measured: 4 months post-operatively
Prevention of Anxiety
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.
Measured: 4 months post-operatively
Prevention of Pain
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.
Measured: 4 months post-operatively
Prevention of Pain
Duration of opioid use post-surgery in all patients enrolled. This will be assessed using the opioid diary.
Measured: 4 months post-operatively
Quality of Life Improvement
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.
Measured: 4 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Why it stopped: Issues with funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Topf, Vanderbilt University Medical Center
- Investigators
- Michael C Topf, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724849
- Sponsor's protocol ID
- 230054
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lydiatt WM, Moran J, Burke WJ. A review of depression in the head and neck cancer patient. Clin Adv Hematol Oncol. 2009 Jun;7(6):397-403.
PubMed 19606075Chhabria KS, Carnaby GD. Psychometric validation of the Center for Epidemiological Studies Depression Scale in Head and Neck Cancer patients. Oral Oncol. 2017 Dec;75:158-162. doi: 10.1016/j.oraloncology.2017.11.010. Epub 2017 Nov 15.
PubMed 29224813Rieke K, Schmid KK, Lydiatt W, Houfek J, Boilesen E, Watanabe-Galloway S. Depression and survival in head and neck cancer patients. Oral Oncol. 2017 Feb;65:76-82. doi: 10.1016/j.oraloncology.2016.12.014. Epub 2017 Jan 1.
PubMed 28109472Archer J, Hutchison I, Korszun A. Mood and malignancy: head and neck cancer and depression. J Oral Pathol Med. 2008 May;37(5):255-70. doi: 10.1111/j.1600-0714.2008.00635.x. Epub 2008 Feb 26.
PubMed 18312300Cramer JD, Johnson JT, Nilsen ML. Pain in Head and Neck Cancer Survivors: Prevalence, Predictors, and Quality-of-Life Impact. Otolaryngol Head Neck Surg. 2018 Nov;159(5):853-858. doi: 10.1177/0194599818783964. Epub 2018 Jun 26.
PubMed 29943677Friedland CJ. Head and Neck Cancer: Identifying Depression as a Comorbidity Among Patients. Clin J Oncol Nurs. 2019 Feb 1;23(1):99-102. doi: 10.1188/19.CJON.99-102.
PubMed 30681992Barber B, Dergousoff J, Slater L, Harris J, O'Connell D, El-Hakim H, Biron VL, Mitchell N, Seikaly H. Depression and Survival in Patients With Head and Neck Cancer: A Systematic Review. JAMA Otolaryngol Head Neck Surg. 2016 Mar;142(3):284-8. doi: 10.1001/jamaoto.2015.3171.
PubMed 26796781Lydiatt WM, Denman D, McNeilly DP, Puumula SE, Burke WJ. A randomized, placebo-controlled trial of citalopram for the prevention of major depression during treatment for head and neck cancer. Arch Otolaryngol Head Neck Surg. 2008 May;134(5):528-35. doi: 10.1001/archotol.134.5.528.
PubMed 18490576Lydiatt WM, Bessette D, Schmid KK, Sayles H, Burke WJ. Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: randomized, double-blind, placebo-controlled clinical trial. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):678-86. doi: 10.1001/jamaoto.2013.3371.
PubMed 23788218Panwar A, Rieke K, Burke WJ, Sayles H, Lydiatt WM; Prevention of Depression in Patients Being Treated for Head and Neck Cancer Trial (PROTECT) study group. Identification of Baseline Characteristics Associated With Development of Depression Among Patients With Head and Neck Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):1004-1010. doi: 10.1001/jamaoto.2018.2228.
PubMed 30286230Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.
PubMed 23549581
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venlafaxine for the Prevention of Depression in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05724849
- Acronym / sponsor ID
- 230054
- Conditions
- Head and Neck Cancer, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Issues with funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine | Experimental | Drug: VenlafaxinePatients who screen negative or meet criteria for mild MDD are eligible for the randomized control trial (RCT) portion of this study in which patients are randomized into either the intervention (venlafaxine) arm or placebo. Participants randomized into the intervention group will be prescribed a starting dose of venlafaxine immediate release (IR) 75mg once daily. The dosing will be increased at the following rate: Week 1: 75mg in AM Week 2: 75mg BID Week 3: 150mg in AM, 75mg in PM Week 4: 150mg BID For patients with hepatic impairment, severe renal impairment, or end stage kidney disease, the starting dose is 37.5 mg once daily, increased by increments of 37.5 mg per day to reach a maximum of 187.5 mg per day, given in two divided doses. |
| Placebo | Placebo comparator | Drug: PlaceboPatients who screen negative or meet criteria for mild MDD are eligible for the randomized control trial (RCT) portion of this study in which patients are randomized into either the intervention (venlafaxine) arm or placebo. Participants randomized to the placebo group will receive a placebo capsule with the same dosing schedule as the intervention group. |
| Observation | Other | Drug: VenlafaxinePatients who screen positive for moderate, moderately-severe, or severe MDD are excluded from the RCT and will be enrolled in the study as an observation cohort. These patients will be offered initiation of venlafaxine and will be referred to our collaborating oncologic psychiatrist. Patients in cohort B will still complete the same patient-reported outcome measures (PROMs) as patients in cohort A, allowing us to collect data and better understand what effects venlafaxine has on patients who are already diagnosed with depression at the start of treatment for HNC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- COHORT A (RCT)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- Have a recently diagnosed cutaneous or mucosal malignancy
Key exclusion criteria (18 listed)
- COHORT A (RCT)
- Score >10 on PHQ-9
- Score between 5-9 on PHQ-9 and elect for psychotherapy
- Age less than 18 years
- Primary malignancy of thyroid or parathyroid origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenlafaxineAlso: EffexorSee arm/group description. | Drug | Observation, Venlafaxine |
| PlaceboSee arm/group description. | Drug | Placebo |
Primary outcome
Prevention of Depression
Time frame: 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.
5 secondary outcomes
Treatment of Depression
Time frame: 4 months post-operatively
Prevention of Anxiety
Time frame: 4 months post-operatively
Prevention of Pain
Time frame: 4 months post-operatively
Prevention of Pain
Time frame: 4 months post-operatively
Quality of Life Improvement
Time frame: 4 months post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 19606075Lydiatt WM, Moran J, Burke WJ. A review of depression in the head and neck cancer patient. Clin Adv Hematol Oncol. 2009 Jun;7(6):397-403.
- Background: PubMed 29224813Chhabria KS, Carnaby GD. Psychometric validation of the Center for Epidemiological Studies Depression Scale in Head and Neck Cancer patients. Oral Oncol. 2017 Dec;75:158-162. doi: 10.1016/j.oraloncology.2017.11.010. Epub 2017 Nov 15.
- Background: PubMed 28109472Rieke K, Schmid KK, Lydiatt W, Houfek J, Boilesen E, Watanabe-Galloway S. Depression and survival in head and neck cancer patients. Oral Oncol. 2017 Feb;65:76-82. doi: 10.1016/j.oraloncology.2016.12.014. Epub 2017 Jan 1.
- Background: PubMed 18312300Archer J, Hutchison I, Korszun A. Mood and malignancy: head and neck cancer and depression. J Oral Pathol Med. 2008 May;37(5):255-70. doi: 10.1111/j.1600-0714.2008.00635.x. Epub 2008 Feb 26.
- Background: PubMed 29943677Cramer JD, Johnson JT, Nilsen ML. Pain in Head and Neck Cancer Survivors: Prevalence, Predictors, and Quality-of-Life Impact. Otolaryngol Head Neck Surg. 2018 Nov;159(5):853-858. doi: 10.1177/0194599818783964. Epub 2018 Jun 26.
- Background: PubMed 30681992Friedland CJ. Head and Neck Cancer: Identifying Depression as a Comorbidity Among Patients. Clin J Oncol Nurs. 2019 Feb 1;23(1):99-102. doi: 10.1188/19.CJON.99-102.
- Background: PubMed 26796781Barber B, Dergousoff J, Slater L, Harris J, O'Connell D, El-Hakim H, Biron VL, Mitchell N, Seikaly H. Depression and Survival in Patients With Head and Neck Cancer: A Systematic Review. JAMA Otolaryngol Head Neck Surg. 2016 Mar;142(3):284-8. doi: 10.1001/jamaoto.2015.3171.
- Background: PubMed 18490576Lydiatt WM, Denman D, McNeilly DP, Puumula SE, Burke WJ. A randomized, placebo-controlled trial of citalopram for the prevention of major depression during treatment for head and neck cancer. Arch Otolaryngol Head Neck Surg. 2008 May;134(5):528-35. doi: 10.1001/archotol.134.5.528.
- Background: PubMed 23788218Lydiatt WM, Bessette D, Schmid KK, Sayles H, Burke WJ. Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: randomized, double-blind, placebo-controlled clinical trial. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):678-86. doi: 10.1001/jamaoto.2013.3371.
- Background: PubMed 30286230Panwar A, Rieke K, Burke WJ, Sayles H, Lydiatt WM; Prevention of Depression in Patients Being Treated for Head and Neck Cancer Trial (PROTECT) study group. Identification of Baseline Characteristics Associated With Development of Depression Among Patients With Head and Neck Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):1004-1010. doi: 10.1001/jamaoto.2018.2228.
- Background: PubMed 23549581Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Topf, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venlafaxine in people with Head and Neck Cancer and Depression, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of Depression (time frame: 4 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724849, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.