Lung CancerPhase 1NCT02094950
Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
A Phase 1 study testing Acupuncture in people with Lung Cancer and Dyspnea, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Dyspnea
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 15 Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- Acupuncture
- Keywords
- concurrent chemotherapy, concurrent radiation
- Medical subject headings
- Lung Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Patient with Dyspnea | Experimental | Not described Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion15 Jul 2015
- Study completion15 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Bauml, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094950
- Sponsor's protocol ID
- UPCC 11513
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2014
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
- ClinicalTrials.gov ID
- NCT02094950
- Acronym / sponsor ID
- UPCC 11513
- Conditions
- Lung Cancer, Dyspnea
- Keywords
- concurrent chemotherapy, concurrent radiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 15 Jul 2015 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Patient with Dyspnea | Experimental | Procedure: Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | Lung Cancer Patient with Dyspnea |
Primary outcome
Dyspnea
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Bauml, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture in people with Lung Cancer and Dyspnea, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.