Plain English Summary
Background and study aims
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, making up around 85-90% of all cases. As the health of the lungs deteriorates, many patients experience breathlessness, as their lungs are no longer able to function properly. This can be painful and distressing to sufferers, as constant breathlessness, even while at rest, can prevent them from taking part in many activities. Currently, the only medical treatment offered for these patients is morphine (a powerful pain-relieving drug), although this is not thought to help particularly and has many unwanted side-effects. Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needels are placed into the body at specific points. Studies have shown that it can help to stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). There is evidence that it is effective in a range of conditions, including problems with breathing. The aim of this study is to find out whether acupuncture treatment can help to relieve breathlessness in patients suffering from NSCLC.
Who can participate?
Adult patients with non-small cell lung cancer (NSCLC) who experience breathlessness at rest.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are given morphine for pain relief only. Those in the second group are given acupuncture treatment. This involves an initial session of acupuncture, where thin needles are placed in the skin in specific places, followed by the semi-permanent acupuncture studs being placed into the skin that are to be left in place for 14 days. Those in the third group are given morphine as well as acupuncture treatment in the same way as the second group. All participants attend study visits at the start of the study and then after 7 and 14 days to complete a physical assessment to measure breathlessness and a number of questionnaires to assess their mood and wellbeing.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Royal Marsden Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2006 to January 2014
Who is funding the study?
Royal Marsden Hospital (UK)
Who is the main contact?
Dr Mary O’Brien
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised study of the value of acupuncture in treating non small cell lung cancer and mesothelioma patients with dyspnoea
Acronym
Study hypothesis
Some studies on breathlessness, while small, have shown acupuncture to have a significant positive effect in the perception of breathlessness in end-stage cancer, chronic obstructive pulmonary disease and asthma. The vast majority of trials of acupuncture for breathlessness have been performed in a non-cancer setting. Therefore, the lack of data regarding effectiveness of acupuncture and standard opioids for cancer-related dyspnoea, together with drawbacks associated with opioid use and service acupuncture in the National Health Service (NHS) for this indication, warrant further research.
Ethics approval
Royal Marsden Research Ethics Committee in May 2006
Study design
Randomised phase II trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Non-small cell lung cancer and mesothelioma
Intervention
Patients are randomised to receive one of the following interventions:
1. Morphine
2. Acupuncture
3. Morphine and acupuncture
After completing baseline assessments patients will undergo treatment on day one according to which treatment arm they have been randomized to. Those in treatment arms two and three will have indwelling acupuncture studs inserted after their initial acupuncture treatment. During the course of day 1 all patients will undergo further assessments after their initial treatment. All patients will return for assessment on days 7 and 14 (this last visit marks the end of trial). Those patients who feel a beneficial effect of the acupuncture studs will be allowed to retain them and followed up in the usual outpatient clinic.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
To investigate the effectiveness of acupuncture for relief of breathlessness in lung cancer
Secondary outcome measures
1. Measures of anxiety, relaxation, other subjective variables (Lar scales)
2. Respiratory rate and lung function tests (Forced Expiratory Volume [FEV], Partial Expiratory Flow Rate [PEFR])
3. Hospital Anxiety and Depression (HAD) Scale
4. Quality of Life (QOL) changes between baseline and seven days
Overall trial start date
01/05/2006
Overall trial end date
31/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with a diagnosis of Non Small Cell Lung Cancer (NSCLC) and mesothelioma and breathless at rest with at least a Visual Analogue Scale (VAS) score >/= 4, or breathlessness at rest
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
174
Participant exclusion criteria
1. Recent acupuncture in the last four weeks
2. Contraindications to acupuncture e.g bleeding abnormality or anticoagulation
3. Current use of morphine in any form (oral or nebuliser) at study entry
4. Untreated reversible anaemia, pleural effusion, pulmonary embolism, pneumonia, ascites, or superior vena cava obstruction, if treatment appropriate
5. Pregnancy
6. Commenced oral or inhaled steroids or changed dose within one week of the start of the study
7. Chemotherapy or radiotherapy or change in hormonotherapy in the last four weeks
Recruitment start date
01/05/2006
Recruitment end date
31/01/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Royal Marsden Hospital (UK)
Sponsor details
Downs road
Sutton
SM2 5PT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Marsden Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary