Acupuncture Feasibility Trial for Dyspnea in Lung Cancer

NCT02094950 | Completed Phase 1 DMC

• 1 other identifier: UPCC 11513
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

concurrent chemotherapy; concurrent radiation

Outcome Measures

Primary Outcomes (1)

• Dyspnea

  10 weeks

Study Arms (1)

Lung Cancer Patient with Dyspnea

EXPERIMENTAL

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Lung Cancer Patient with Dyspnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Dyspnea

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Joshua Bauml, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: July 15, 2015
• Study Completion: July 15, 2015
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)