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Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Phase 3 trial testing Varenicline in Lung Carcinoma in 23 participants. Terminated before completion.
| Lead sponsor | Alliance for Clinical Trials in Oncology |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 23 |
| Start date | 29 September 2017 |
| Primary completion | 28 May 2021 |
| Estimated completion | 15 April 2022 |
| Sites | 374 locations across United States |
Alliance for Clinical Trials in Oncology
18 and older, any sex, with Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients that died within 30 days of surgery
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 | |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Number of patients re-hospitalized within 30 days of surgery
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 | |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 | |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We wi
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 | |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We wi
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 | |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We wi
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group (Varenicline and Behavioral Intervention) | 0 | |
| Control Group (Placebo and Behavioral Intervention) | 0 |
Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention Group (Vareni… | Control Group (Placebo and… |
|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — |
| Gen disord and admin site conds-Oth spec | General disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Reaction | System | Intervention Group (Vareni… | Control Group (Placebo and… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Edema face | General disorders | — | — |
| Gen disord and admin site conds-Oth spec | General disorders | — | — |
| Personality change | Psychiatric disorders | — | — |
| Psychiatric disorders - Other, specify | Psychiatric disorders | — | — |
| Suicidal ideation | Psychiatric disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
Most-reported serious reactions: Atrial fibrillation, Gen disord and admin site conds-Oth spec, Pneumonitis, Hypotension.
Data from ClinicalTrials.gov NCT02856581 adverse events section.
This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline \[tobacco cessation service available through a toll-free telephone number\] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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