Back to resultsAcupuncture Feasibility Trial for Dyspnea in Lung Cancer
Primary Purpose
Lung Cancer, Dyspnea
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring concurrent chemotherapy, concurrent radiation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
- Completion of concurrent CRT at least 6 months prior to randomization.
- 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)
- Ability to understand written English -Willingness to adhere to all study-related procedures
- Age 18 years old
- ECOG Performance Status 1-3
Exclusion Criteria:
- Current receipt of therapy for treatment related pneumonitis for 3 weeks.
- Surgical resection of this LC (lobectomy or pneumonectomy)
- 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 bleeding disorder by history
- Life expectancy of 12 weeks, as assessed by primary oncologist
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lung Cancer Patient with Dyspnea
Arm Description
Outcomes
Primary Outcome Measures
Dyspnea
Secondary Outcome Measures
Full Information
NCT ID
NCT02094950
First Posted
March 20, 2014
Last Updated
July 22, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02094950
Brief Title
Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
Official Title
Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 15, 2015 (Actual)
Study Completion Date
July 15, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single arm clinical trial to establish the feasibility of conducting a clinical trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed chemoradiotherapy. Twelve subjects with dyspnea will be recruited to this clinical trial. Up to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. The primary outcome will be dyspnea as measured by the English version of the Cancer Dyspnea Scale at the completion of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Dyspnea
Keywords
concurrent chemotherapy, concurrent radiation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung Cancer Patient with Dyspnea
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
Dyspnea
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
Completion of concurrent CRT at least 6 months prior to randomization.
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)
Ability to understand written English -Willingness to adhere to all study-related procedures
Age 18 years old
ECOG Performance Status 1-3
Exclusion Criteria:
Current receipt of therapy for treatment related pneumonitis for 3 weeks.
Surgical resection of this LC (lobectomy or pneumonectomy)
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 bleeding disorder by history
Life expectancy of 12 weeks, as assessed by primary oncologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Bauml, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
We'll reach out to this number within 24 hrs