Breast CancerPhase 2ACUFOCINNCT02275403
Standard Care Alone or With Acupuncture for CIPN in Breast Cancer and Multiple Myeloma
A Phase 2 study testing Acupuncture and Medication taken to manage the symptom burden of CIPN in people with Breast Cancer and Multiple Myeloma, run by The Christie NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to determine whether the addition of acupuncture to standard treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer during or following treatment with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Multiple Myeloma, Gastrointestinal Cancer
- What is being tested?
- Acupuncture and Medication taken to manage the symptom burden of CIPN
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Apr 2015to 17 Dec 2018
- Phase
- Phase 2
- 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
- Patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer who are receiving or who have received neurotoxic chemotherapy treatment for their condition
- The capacity to understand the patient information sheet and the ability to give written informed consent
- Willingness and ability to comply with scheduled visits and study procedures, including the self-report QoL questionnaires and patient diaries
- Age ≥ 18 years; no upper age limit
- CIPN of ≥ Grade II (CTCAE v4.03)
- Platelet count of ≥ 30 x 10*9/L
- Neutrophil count of ≥ 0.5 x 10*9/L
- MYMOP2 score of their most troubling CIPN symptom ≥ 3
Who cannot join
- Patients who have previously received acupuncture for neuropathy
- Patients who have received acupuncture for any indication, other than neuropathy, within the previous 6 months
- Women who are pregnant or breast feeding
- Co-morbidity with a bleeding disorder
- Patients with an aversion to needles
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Christie NHS Foundation Trust
Manchester, M20 4BX
The Royal Oldham Hospital
Oldham, OL1 2JH
About this study
Official title: Randomised Clinical Trial of Acupuncture Plus Standard Care Versus Standard Care for Chemotherapy Induced Peripheral Neuropathy (CIPN)
The purpose of this study is to determine whether the addition of acupuncture to standard treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer during or following treatment with neurotoxic chemotherapy.
Read the detailed description
Chemotherapy Induced Peripheral Neuropathy (CIPN) is a significant clinical challenge for patients receiving specific chemotherapy regimen (e.g. taxanes and Bortezomib) and critically, if severe, CIPN can lead to the discontinuation of life prolonging treatment. CIPN poses a major problem for patient care as standard pharmacological treatments for CIPN have been found to be commonly ineffective and are often inadequate due to dosing complexities, delayed analgesic onset and side effects.
A service evaluation of the clinical data secured from using acupuncture to manage CIPN symptoms over a period of 18 months at The Christie National Health Service (NHS) Foundation Trust suggests it has the potential to provide an efficacious management tool to be used in addition to standard medication. This aim of this trial is to formally evaluate a 10 week course of acupuncture in the management of CIPN of grade 2 or above (symptoms experienced have a functional impact, graded in accordance with CTCAE v4.03), in patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer.
This is a randomised, phase II, single-centre, controlled, open label trial . Patients meeting eligibility criteria will be randomised to receive acupuncture plus standard care (treatment arm) or standard care alone (control arm). Patients in both arms of the study will receive standard medication to manage symptoms of CIPN, as determined by a clinician in accordance with local trust policy. In addition to this, patients randomised to the treatment arm will receive 40 minute sessions of acupuncture on a weekly basis for 10 weeks. All patients will be offered acupuncture, to commence off trial at the end of their 10 week study period.
Outcome measures have been focused on assessing the impact of acupuncture on the patients' quality of life, symptom burden of CIPN and quantifying any effect size. There will also be a preliminary health economic evaluation of cost effectiveness. The data will be disseminated in addition to being used to establish whether a larger, multisite trial to confirm efficacy across all diagnostic groups, user acceptability and cost effectiveness is appropriate. This work will facilitate the team validating the study protocol and design as a template for a multicentre study and confirm user acceptability of the approach through additional qualitative data collected through focus group work at the completion of study participation.
- Being tested
- Acupuncture, Medication taken to manage the symptom burden of CIPN
- Medical subject headings
- Breast Neoplasms, Multiple Myeloma, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
10 x weekly sessions (40 minutes per session) of acupuncture by a trained therapist.
Medication taken to manage the symptom burden of CIPNOther
Standard of care medication to manage CIPN symptoms, as determined by a clinician in accordance with local trust policy. The standard care for CIPN includes a variety of oral medications to manage the altered sensations caused by damage to the peripheral nerves. These oral medications include, but are not limited to; Gabapentin, Amitriptyline and Pregabalin. In addition, medicated creams and gels may be used.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard care plus acupuncture | Experimental | Medication taken to manage the symptom burden of CIPN plus acupuncture Receives: Procedure: Acupuncture; Other: Medication taken to manage the symptom burden of CIPN |
| Arm B: Standard care alone | Active comparator | Medication taken to manage the symptom burden of CIPN Receives: Other: Medication taken to manage the symptom burden of CIPN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Measure Yourself Medical Outcome Profile (MYMOP2) score of the most troubling symptom of CIPN
Assessed from patient completed questionnaire data: MYMOP2
Measured: Baseline, week 6 and week 10
Secondary outcomes (8)
Change in grade of CIPN
Assessed by a clinician using a set of standardised questions, as a prompt, to assess the functional impact of CIPN. CIPN will be graded in accordance with CTCAE v4.03
Measured: Baseline, week 6 and week 10
Change in use of concomitant CIPN related medication
Includes change in dose and change in medication used to manage the symptom burden of CIPN.
Measured: Up to 10 weeks after baseline
Change in chemotherapy dosage
Measured: Up to 10 weeks after baseline
Pain related scores
Captured by the patient at baseline and then daily in the patient diary from week 1
Measured: Up to 10 weeks after baseline
Quality of life
Assessed from patient completed questionnaire data: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the associated CIPN20 module
Measured: Baseline, week 6 and week 10
Acupuncture treatment compliance
Compliance to attending weekly acupuncture sessions
Measured: From week 1 (start of acupuncture treatment) until week 10
Preliminary health economic evaluation of cost effectiveness
Data will be captured from patient diaries completed continuously from week 1 until week 10 and from the patient notes. Patients will also complete the Euroqol (EQ-5D-5L) questionnaire at baseline, week 6 and week 10.
Measured: Up to 10 weeks after baseline
Uptake of the offer of acupuncture at 10 weeks
All patients will be offered acupuncture, to commence after the 10 week study period, at the 6 week visit. Acceptance of the offer will be captured at the 10 week visit.
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 posted27 Oct 2014 (estimated)
- Study start13 Apr 2015
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmie Taylor, The Christie NHS Foundation Trust
- Investigators
- Andrew Wardley, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275403
- Sponsor's protocol ID
- 12_DOG06_165
- Other IDs
- PB-PG-0213-30129, CFTSp062
- Acronym
- ACUFOCIN
- Status last verified
- Jan 2019
- First submitted
- 22 Oct 2014
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial of Acupuncture Plus Standard Care Versus Standard Care for Chemotherapy Induced Peripheral Neuropathy (CIPN)
- ClinicalTrials.gov ID
- NCT02275403
- Acronym / sponsor ID
- ACUFOCIN / 12_DOG06_165
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Apr 2015 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 27 Oct 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.
The purpose of this study is to determine whether the addition of acupuncture to standard treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer during or following treatment with neurotoxic chemotherapy.
Detailed description
Chemotherapy Induced Peripheral Neuropathy (CIPN) is a significant clinical challenge for patients receiving specific chemotherapy regimen (e.g. taxanes and Bortezomib) and critically, if severe, CIPN can lead to the discontinuation of life prolonging treatment. CIPN poses a major problem for patient care as standard pharmacological treatments for CIPN have been found to be commonly ineffective and are often inadequate due to dosing complexities, delayed analgesic onset and side effects.
A service evaluation of the clinical data secured from using acupuncture to manage CIPN symptoms over a period of 18 months at The Christie National Health Service (NHS) Foundation Trust suggests it has the potential to provide an efficacious management tool to be used in addition to standard medication. This aim of this trial is to formally evaluate a 10 week course of acupuncture in the management of CIPN of grade 2 or above (symptoms experienced have a functional impact, graded in accordance with CTCAE v4.03), in patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer.
This is a randomised, phase II, single-centre, controlled, open label trial . Patients meeting eligibility criteria will be randomised to receive acupuncture plus standard care (treatment arm) or standard care alone (control arm). Patients in both arms of the study will receive standard medication to manage symptoms of CIPN, as determined by a clinician in accordance with local trust policy. In addition to this, patients randomised to the treatment arm will receive 40 minute sessions of acupuncture on a weekly basis for 10 weeks. All patients will be offered acupuncture, to commence off trial at the end of their 10 week study period.
Outcome measures have been focused on assessing the impact of acupuncture on the patients' quality of life, symptom burden of CIPN and quantifying any effect size. There will also be a preliminary health economic evaluation of cost effectiveness. The data will be disseminated in addition to being used to establish whether a larger, multisite trial to confirm efficacy across all diagnostic groups, user acceptability and cost effectiveness is appropriate. This work will facilitate the team validating the study protocol and design as a template for a multicentre study and confirm user acceptability of the approach through additional qualitative data collected through focus group work at the completion of study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard care plus acupuncture | Experimental | Procedure: Acupuncture, Other: Medication taken to manage the symptom burden of CIPNMedication taken to manage the symptom burden of CIPN plus acupuncture |
| Arm B: Standard care alone | Active comparator | Other: Medication taken to manage the symptom burden of CIPNMedication taken to manage the symptom burden of CIPN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer who are receiving or who have received neurotoxic chemotherapy treatment for their condition
- The capacity to understand the patient information sheet and the ability to give written informed consent
- Willingness and ability to comply with scheduled visits and study procedures, including the self-report QoL questionnaires and patient diaries
- Age ≥ 18 years; no upper age limit
- CIPN of ≥ Grade II (CTCAE v4.03)
Key exclusion criteria (5 listed)
- Patients who have previously received acupuncture for neuropathy
- Patients who have received acupuncture for any indication, other than neuropathy, within the previous 6 months
- Women who are pregnant or breast feeding
- Co-morbidity with a bleeding disorder
- Patients with an aversion to needles
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 |
|---|---|---|
| Acupuncture10 x weekly sessions (40 minutes per session) of acupuncture by a trained therapist. | Procedure or surgery | Arm A: Standard care plus acupuncture |
| Medication taken to manage the symptom burden of CIPNStandard of care medication to manage CIPN symptoms, as determined by a clinician in accordance with local trust policy. The standard care for CIPN includes a variety of oral medications to manage the altered sensations caused by damage to the peripheral nerves. These oral medications include, but are not limited to; Gabapentin, Amitriptyline and Pregabalin. In addition, medicated creams and gels may be used. | Other | Arm A: Standard care plus acupuncture, Arm B: Standard care alone |
Primary outcome
Change in Measure Yourself Medical Outcome Profile (MYMOP2) score of the most troubling symptom of CIPN
Time frame: Baseline, week 6 and week 10
Assessed from patient completed questionnaire data: MYMOP2
8 secondary outcomes
Change in grade of CIPN
Time frame: Baseline, week 6 and week 10
Change in use of concomitant CIPN related medication
Time frame: Up to 10 weeks after baseline
Change in chemotherapy dosage
Time frame: Up to 10 weeks after baseline
Pain related scores
Time frame: Up to 10 weeks after baseline
Quality of life
Time frame: Baseline, week 6 and week 10
Acupuncture treatment compliance
Time frame: From week 1 (start of acupuncture treatment) until week 10
Preliminary health economic evaluation of cost effectiveness
Time frame: Up to 10 weeks after baseline
Uptake of the offer of acupuncture at 10 weeks
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 31 Jan 2019.
- 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.
Andrew Wardley study chair
The Christie NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and Medication taken to manage the symptom burden of CIPN in people with Breast Cancer and Multiple Myeloma, run by The Christie NHS Foundation Trust at 2 sites 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 8 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Measure Yourself Medical Outcome Profile (MYMOP2) score of the most troubling symptom of CIPN (time frame: Baseline, week 6 and week 10). 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 31 Jan 2019.