Recruitment

Recruitment Status
Completed

Inclusion Criteria

Completion of concurrent CRT at least 6 months prior to randomization.
Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
Dyspnea which worsened after Chemoradiotherapy, leading to a ATS dyspnea score greater than or equal to 2 (Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level)
...
Completion of concurrent CRT at least 6 months prior to randomization.
Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
Dyspnea which worsened after Chemoradiotherapy, leading to a ATS dyspnea score greater than or equal to 2 (Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level)
Age 18 years old
Ability to understand written English -Willingness to adhere to all study-related procedures
ECOG Performance Status 1-3

Exclusion Criteria

Surgical resection of this LC (lobectomy or pneumonectomy)
Life expectancy of 12 weeks, as assessed by primary oncologist
Current bleeding disorder by history
...
Surgical resection of this LC (lobectomy or pneumonectomy)
Life expectancy of 12 weeks, as assessed by primary oncologist
Current bleeding disorder by history
Another organic cause of dyspnea necessitating treatment (eg pleural effusion appropriate for thoracentesis, rapidly progressive intrathoracic recurrence, symptomatic pulmonary embolus after CRT, untreated anemia with hemoglobin8 g/dL)
Current receipt of therapy for treatment related pneumonitis for 3 weeks.

Summary

Conditions
  • Dyspnea
  • Lung Cancer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Completion of concurrent CRT at least 6 months prior to randomization.
Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
Dyspnea which worsened after Chemoradiotherapy, leading to a ATS dyspnea score greater than or equal to 2 (Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level)
...
Completion of concurrent CRT at least 6 months prior to randomization.
Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
Dyspnea which worsened after Chemoradiotherapy, leading to a ATS dyspnea score greater than or equal to 2 (Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level)
Age 18 years old
Ability to understand written English -Willingness to adhere to all study-related procedures
ECOG Performance Status 1-3

Exclusion Criteria

Surgical resection of this LC (lobectomy or pneumonectomy)
Life expectancy of 12 weeks, as assessed by primary oncologist
Current bleeding disorder by history
...
Surgical resection of this LC (lobectomy or pneumonectomy)
Life expectancy of 12 weeks, as assessed by primary oncologist
Current bleeding disorder by history
Another organic cause of dyspnea necessitating treatment (eg pleural effusion appropriate for thoracentesis, rapidly progressive intrathoracic recurrence, symptomatic pulmonary embolus after CRT, untreated anemia with hemoglobin8 g/dL)
Current receipt of therapy for treatment related pneumonitis for 3 weeks.

Tracking Information

NCT #
NCT02094950
Collaborators
Not Provided
Investigators
  • Principal Investigator: Joshua Bauml, MD Abramson Cancer Center of the University of Pennsylvania
  • Joshua Bauml, MD Abramson Cancer Center of the University of Pennsylvania