Acupuncture Feasibility Trial for Dyspnea in Lung Cancer

Lung Cancer Clinical Trial

Official title:

Acupuncture Feasibility Trial for Dyspnea in Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094950
• Other study ID #: UPCC 11513
• Status: Completed
• Phase: Phase 1
• Start date: March 2014
• Est. completion date: July 15, 2015

Study information

• Verified date: July 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 15, 2015
• Est. primary completion date: July 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea		10 weeks