Acupuncture Feasibility Trial for Dyspnea in Lung Cancer

NCT ID: NCT02094950

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-07-15

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.

Conditions

Lung Cancer; Dyspnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE

Study Groups

Lung Cancer Patient with Dyspnea

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Interventions

Acupuncture

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Bauml, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 11513

Identifier Type: -

Identifier Source: org_study_id