Clinical trial · Interventional
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is designed to test the efficacy of fluoxetine to improve patient's quality of life during chemotherapy. An innovative application of a selective serotonin reuptake inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of life.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluoxetine | Drug | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine + cisplatin + fluoxetine
- description
- Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.
- interventionNames
- Drug: cisplatin
- Drug: fluoxetine
- Drug: gemcitabine hydrochloride
Primary outcomes (3)
- measure
- Change in the MHI-17 global psychological distress subscale
- timeFrame
- Up to 8 weeks
- measure
- Overall survival
- timeFrame
- Up to 2 years post-treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Eligibility Criteria: 1. Histologic Documentation: All patients must have histologically or cytologically documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types). 2. Extent of Disease: Stage IIIB/IV cancer by the international staging system or any Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after surgery or radiotherapy. * Patients with Stage IIIB because of a malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and chest irradiation are not eligible. * Patients with known CNS metastases are not eligible. 3. Measurable or Non-Measurable Disease * Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan. * Non-measurable Disease: Only those non-measurable disease patients with ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease are eligible. All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions, are not eligible. Lesions that are considered non-measurable include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions 4. Prior Treatment: * No prior chemotherapy. * ≥ 2 weeks since radiation therapy. * No antidepressant treatment (eg, selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase inhibitors) currently or within the last month. 5. If the patient requires pain medication, pain must be managed with non-codeine preparations, including but not limited to: acetaminophen, any morphine based preparation (short or long acting), hydromorphone, fentanyl, levorphanol or methadone. 6. CTC Performance Status 0-1. 7. Non-pregnant and non-nursing because of significant risk to the fetus/infant. 8. Required Initial Laboratory Data: * Granulocytes ≥ 1,500/µl * Platelet count ≥ 100,000/µl * Serum creatinine ≤ 1.5 mg/dl or Calculated CrCl ≥ 60 ml/min * Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) * Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.0 x ULN
References
Publications (0)
Data not yet available