CancerARTNCT03433118
Acupuncture in Cancer Patients Undergoing Radiotherapy Treatment
A study testing Acupuncture in people with Cancer, run by Royal London Hospital for Integrated Medicine at 1 site in United Kingdom.
Trial summary
Feasibility randomized controlled trial of standard care v standard care + acupuncture administered by specially-trained therapy radiographers in patients undergoing radiotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2015to 31 Oct 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients due to receive radical (curative) radiotherapy
- Patients of either gender and older than 16 years old.
- Patients with any cancer diagnosis.
- Patients willing to participate in the study and be randomised to one of the two treatment arms.
- Patients willing to attend at least 3 acupuncture treatments if assigned to the acupuncture intervention.
- Palliative patients.
Show all 12Show fewer
- Patients unwilling to participate (for instance due to needle phobia).
- Patients currently receiving acupuncture.
- Patients with a platelet count <20 000mm.
- Patients with a white blood cell count <1000mm.
- Patients with severe clotting dysfunction or who bruise spontaneously.
- Patients unable to complete the questionnaires as judged by the investigators.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospitals Cancer Clinical Trials Unit
London, NW1 2BU
About this study
Official title: A Feasibility Study of Acupuncture to Improve Quality of Life and Fatigue in Cancer Patients Undergoing Radiotherapy Treatment
Feasibility randomized controlled trial of standard care v standard care + acupuncture administered by specially-trained therapy radiographers in patients undergoing radiotherapy. It is a feasibility study to investigate all aspects of a future definitive randomized controlled trial, including statistical power calculation, hence there is no primary outcome or time point.
Mixed methods: literature review, model validity, training and mentoring of radiographers, processes, resources, interventions, procedures, patient clinical outcomes, patient and stakeholder qualitative outcomes
Read the detailed description
The aim of the 'Acupuncture to improve quality of life and fatigue in cancer patients undergoing Radiotherapy Treatment' (ART) project is to investigate all aspects of the feasibility of undertaking clinical research on acupuncture with patients having radiotherapy at the University College Hospital (UCH) Cancer division.
The program includes an exploratory feasibility randomized controlled trial to investigate all aspects of a future definitive randomized controlled trial, including: organizational and procedural issues, patient group (including cancer diagnosis and stage), statistical power calculation, primary outcome measure and time point. It is NOT intended to deliver definitive results in terms of clinical outcomes.
ART aims to establish a platform for the investigation of integrating complementary therapy into cancer care, between the Royal London Hospital for Integrated Medicine (RLHIM) and the UCH cancer division. The development of a research project to investigate the use of acupuncture, a therapy not currently provided by the cancer division, to address the key concerns of cancer patients was the starting point. The intention is to evaluate the feasibility of such research, not to produce definitive results.
The greatest concerns of people with cancer include anxiety, fatigue, sleep problems and pain as a consequence of their disease and its treatment. Many patients find complementary therapies beneficial for these problems. UCH and RLHIM are both part of the University College London Hospital NHS Trust. The RLHIM is a specialist provider of complementary therapies, and offers treatment to cancer patients attending for radiotherapy and chemotherapy at UCH.
ART uses multiple methods, including a systematic review of the literature, model validity expert consensus, a novel therapy (acupuncture) and mode of delivery (specially trained health professionals already working in the radiotherapy department), and standard measures of outcome, culminating in a feasibility randomized controlled clinical trial.
The research program will evaluate all involved processes, resources, interventions and procedures. Outcomes measured included patient clinical outcomes, and the views of patients and stakeholders.
The research team comprises the Royal London Hospital for Integrated Medicine (RLHIM) research team, UCH Cancer Clinical Trials Unit (CCTU), a Steering Group including representatives of all interested parties including patients, an International Scientific Advisory Committee, an Acupuncture Expert Panel, with support from Quality Health Ltd.
- Conditions
- Cancer
- Being tested
- Acupuncture
- Keywords
- fatigue, health-related quality of life
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture administered by specially-trained therapeutic radiographers
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture administered by specially-trained therapeutic radiographers to patients attending the UCH radiotherapy department for radiotherapy intended to be curative of their cancer Receives: Device: Acupuncture |
| Standard care | No intervention | Standard care for patients attending the UCH radiotherapy department for radiotherapy intended to be curative of their cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQC-30
EORTC QLQC-30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. A well-validated quality of life questionnaire for cancer patients focusing on functional assessment. It consists of nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. High internal consistency and construct validity have been demonstrated.
Measured: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
Secondary outcomes (3)
MFI
Multidimensional Fatigue Inventory. A well-validated scale comprising 20 items measuring general fatigue including dimensions of physical and mental fatigue.
Measured: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
MSAS
Memorial Symptom Assessment Scale. A multidimensional scale which evaluates 32 physical and psychological symptoms associated with cancer and its treatment.
Measured: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
EQ-5D-5L
European Quality of Life 5 Dimensions 5 levels. A well-validated instrument which includes five indices to represent patients' Health Related Quality of Life: mobility; self-care; usual activities; pain/discomfort; anxiety/depression
Measured: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start12 Aug 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT) comparing standard care against standard care with additional acupuncture
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal London Hospital for Integrated Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Peter A Fisher, MD, Principal investigator, Royal London Hospital for Integrated Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433118
- Sponsor's protocol ID
- 15/0357
- Acronym
- ART
- Status last verified
- Feb 2018
- First submitted
- 24 Feb 2017
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Acupuncture to Improve Quality of Life and Fatigue in Cancer Patients Undergoing Radiotherapy Treatment
- ClinicalTrials.gov ID
- NCT03433118
- Acronym / sponsor ID
- ART / 15/0357
- Conditions
- Cancer
- Keywords
- fatigue, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Royal London Hospital for Integrated MedicineUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 12 Aug 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 14 Feb 2018 (actual)
- 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.
Feasibility randomized controlled trial of standard care v standard care + acupuncture administered by specially-trained therapy radiographers in patients undergoing radiotherapy. It is a feasibility study to investigate all aspects of a future definitive randomized controlled trial, including statistical power calculation, hence there is no primary outcome or time point.
Mixed methods: literature review, model validity, training and mentoring of radiographers, processes, resources, interventions, procedures, patient clinical outcomes, patient and stakeholder qualitative outcomes
Detailed description
The aim of the 'Acupuncture to improve quality of life and fatigue in cancer patients undergoing Radiotherapy Treatment' (ART) project is to investigate all aspects of the feasibility of undertaking clinical research on acupuncture with patients having radiotherapy at the University College Hospital (UCH) Cancer division.
The program includes an exploratory feasibility randomized controlled trial to investigate all aspects of a future definitive randomized controlled trial, including: organizational and procedural issues, patient group (including cancer diagnosis and stage), statistical power calculation, primary outcome measure and time point. It is NOT intended to deliver definitive results in terms of clinical outcomes.
ART aims to establish a platform for the investigation of integrating complementary therapy into cancer care, between the Royal London Hospital for Integrated Medicine (RLHIM) and the UCH cancer division. The development of a research project to investigate the use of acupuncture, a therapy not currently provided by the cancer division, to address the key concerns of cancer patients was the starting point. The intention is to evaluate the feasibility of such research, not to produce definitive results.
The greatest concerns of people with cancer include anxiety, fatigue, sleep problems and pain as a consequence of their disease and its treatment. Many patients find complementary therapies beneficial for these problems. UCH and RLHIM are both part of the University College London Hospital NHS Trust. The RLHIM is a specialist provider of complementary therapies, and offers treatment to cancer patients attending for radiotherapy and chemotherapy at UCH.
ART uses multiple methods, including a systematic review of the literature, model validity expert consensus, a novel therapy (acupuncture) and mode of delivery (specially trained health professionals already working in the radiotherapy department), and standard measures of outcome, culminating in a feasibility randomized controlled clinical trial.
The research program will evaluate all involved processes, resources, interventions and procedures. Outcomes measured included patient clinical outcomes, and the views of patients and stakeholders.
The research team comprises the Royal London Hospital for Integrated Medicine (RLHIM) research team, UCH Cancer Clinical Trials Unit (CCTU), a Steering Group including representatives of all interested parties including patients, an International Scientific Advisory Committee, an Acupuncture Expert Panel, with support from Quality Health Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT) comparing standard care against standard care with additional acupuncture
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureAcupuncture administered by specially-trained therapeutic radiographers to patients attending the UCH radiotherapy department for radiotherapy intended to be curative of their cancer |
| Standard care | No intervention | –Standard care for patients attending the UCH radiotherapy department for radiotherapy intended to be curative of their cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients due to receive radical (curative) radiotherapy
- Patients of either gender and older than 16 years old.
- Patients with any cancer diagnosis.
- Patients willing to participate in the study and be randomised to one of the two treatment arms.
- Patients willing to attend at least 3 acupuncture treatments if assigned to the acupuncture intervention.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| AcupunctureAcupuncture administered by specially-trained therapeutic radiographers | Device | Acupuncture |
Primary outcome
EORTC QLQC-30
Time frame: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
EORTC QLQC-30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. A well-validated quality of life questionnaire for cancer patients focusing on functional assessment. It consists of nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. High internal consistency and construct validity have been demonstrated.
3 secondary outcomes
MFI
Time frame: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
MSAS
Time frame: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
EQ-5D-5L
Time frame: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
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 14 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Peter A Fisher, MD principal investigator
Royal London Hospital for Integrated Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Cancer, run by Royal London Hospital for Integrated Medicine at 1 site in United Kingdom.
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 12 inclusion and 1 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 14 Feb 2018. 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 Kingdom. 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.
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?
EORTC QLQC-30 (time frame: Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)). 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 14 Feb 2018.