Pancreatic Ductal Adenocarcinoma, Periampullary Cancer
Conditions
Brief summary
Use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.
Detailed description
Anti-depressants have been shown to be beneficial in cancer participants. They reduce depressive symptoms and improve quality of life. Randomized trials have shown that antidepressants can reduce the development of depression in non-depressed participants with breast, melanoma, and head and neck cancers. It has been shown that treating depression can impact survival in cancer participants. Additionally, depressed pancreatic cancer participants have worse survival. Therefore, anti-depressants may also have implications for cancer treatment.
Interventions
DRUGEscitalopram
Participants will receive Escitalopram 2 weeks: 10 mg/day (1 capsule) 8 weeks: 20 mg/day (2 capsules) 2 weeks: 10 mg/day (1 capsule)
OTHERPlacebo
Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must have histologically or cytologically confirmed localized or locally advanced pancreatic ductal adenocarcinoma or other periampullary adenocarcinoma (bile duct, duodenal, ampullary) 2. Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine 3. Aged 18-80 years. 4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2 5. Planned to have at least 12 weeks of neoadjuvant chemotherapy as standard of care cancer treatment 6. No diagnosis of bipolar disease 7. Willing to comply with all study procedures and be available for the duration of the study 8. Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. Patients under the age of 18 or over 80 2. Metastatic pancreatic or other periampullary cancer 3. Resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks. 4. Currently on an antidepressant, anti-anxiety, anti-bipolar or anti-psychotic medicine. Patients who have taken MAOIs (Monoamine Oxidase Inhibitors) within the past 6 months are excluded. 5. Patients with a history of seizure disorder 6. Patients with a recent medical history of myocardial infarction or unstable heart disease 7. Patients with a history of QTc prolongation or torsade de points, a baseline QTc 1. interval of \> 500ms, a history of drug-induced QTc prolongation or congenital long QT 2. syndrome 8. Patients with Child-Pugh score of B or C 9. Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) \< 45. 10. Patients who cannot ingest oral medication 11. Patients with any history of mania 12. Known allergy to escitalopram 13. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Rate of Depression | 12 weeks from the start of treatment | Rate of depression will be measured using the Quick Inventory of Depressive Symptoms (QIDS) survey. This survey has 16 questions that are specific to the symptomatology of depression. Answers are given in the form of a four-point Likert scale ranging from 0-3, with zero relating to a standard sense of well-being and three correlating to the greatest feelings of depression. The survey is divided into 9 domains, and the survey is scored by adding the highest score on any one of the questions in each of the domains. Total scores range from 0 to 27, with greater scores indicating greater symptoms of depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) Survey | Up to 12 weeks from the treatment date | The FACT-Hep has 27 general questions and 18 questions that are specific to hepatopancreatobiliary cancer, for a total of 45 questions. The general questions span four domains: physical, social/family, emotional, and functional well-being 21. It requires less than 10 minutes to complete and targets the 6th-grade reading level. Answers are given in the form of a five-point Likert scale as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), and 4 (Very much). Points are re-calibrated and compiled, such that high scores indicate a higher quality of life. Scores range from 0 to 180. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving Escitalopram Escitalopram: Participants will receive Escitalopram 2 weeks: 10 mg/day (1 capsule) 8 weeks: 20 mg/day (2 capsules) 2 weeks: 10 mg/day (1 capsule) | 2 |
| Participants Receiving Placebo Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Participants Receiving Escitalopram | Participants Receiving Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 2 / 2 | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 |
Outcome results
Primary
Change in the Rate of Depression
Rate of depression will be measured using the Quick Inventory of Depressive Symptoms (QIDS) survey. This survey has 16 questions that are specific to the symptomatology of depression. Answers are given in the form of a four-point Likert scale ranging from 0-3, with zero relating to a standard sense of well-being and three correlating to the greatest feelings of depression. The survey is divided into 9 domains, and the survey is scored by adding the highest score on any one of the questions in each of the domains. Total scores range from 0 to 27, with greater scores indicating greater symptoms of depression.
Time frame: 12 weeks from the start of treatment
Population: 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving Escitalopram | Change in the Rate of Depression | 13 QIDS score |
Secondary
Quality of Life Using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) Survey
The FACT-Hep has 27 general questions and 18 questions that are specific to hepatopancreatobiliary cancer, for a total of 45 questions. The general questions span four domains: physical, social/family, emotional, and functional well-being 21. It requires less than 10 minutes to complete and targets the 6th-grade reading level. Answers are given in the form of a five-point Likert scale as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), and 4 (Very much). Points are re-calibrated and compiled, such that high scores indicate a higher quality of life. Scores range from 0 to 180.
Time frame: Up to 12 weeks from the treatment date
Population: 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving Escitalopram | Quality of Life Using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) Survey | 90 FACTS score |