Moxa for CIP presentation 2016

Using daily self-administered
moxibustion to Zusanli ST-36 to
reduce chemotherapy induced
pancytopenia: a feasibility study
Beverley de Valois Phd LicAc FBAcC
Research Acupuncturist
Lynda Jackson Macmillan Centre
Mount Vernon Cancer Centre
Northwood, Middlesex UK
Study acknowledgements
• British Acupuncture Council (BAcC) Research Fund
• Lynda Jackson Macmillan Centre (LJMC)
• Supportive Oncology Research Team (SORT)
• Mount Vernon Cancer Centre (MVCC)
Research Team
• Dr Beverley de Valois
• Principle Investigator, LJMC
• Teresa Young
• Research Co-ordinator, LJMC
• Dr Rob Glynne-Jones
• Macmillan Lead Clinician in Gastrointestinal Cancer, MVCC
• Dr Friedrich Staebler
• Integrated Medical Practitioner (London) BAcC
• Clare Scarlett
• Data Administrator, LJMC
• Anna Petruckevitch
• Statistician, MVCC
Approvals
• Conducted in compliance with the Helsinki Declaration
• Badged with the National Cancer Research Network
(UKCRN Study ID 19916)
• NHS Research Ethics Committee (REC) approval grante
(London – Fulham REC, ref 15/LO/1571)
• Local Research & Development approval
• Study descriptions at:
• Cancer Research UK (CRUK) clinical trials database
• ClinicalTrials.gov
https://clinicaltrials.gov/ct2/show/NCT02781155
The intervention
• Teaching chemotherapy
patients to use daily selfadministered moxibustion
to Zusanli ST-36 to reduce
chemotherapy induced
pancytopenia
Moxibustion (moxa)
• Uses heat from a smouldering herb (Artemesia
vulgaris or mugwort) to stimulate acupuncture
points, as well as, or instead of, needles
Acupuncture point Zusanli ST-36
• Most important point to:
• Generate qi and blood
• Tonify qi of the whole
body
• Preserve/maintain health
• Prevent illness
• “All diseases can be
treated” (Qin Cheng-zu, Song
dynasty)
Deadman P, Al-Khafaji M, Baker K (2007) A Manual of Acupuncture. Journal of Chinese
Medicine Publications: Hove.
Background: CIP
• Chemotherapy agents reduce bone marrow activity
• Chemotherapy induced pancytopenia (CIP)
• White blood cell (WBC) – leucopoenia, neutropenia
• Red blood cell (RBC) – anaemia
• Platelet counts – thrombocytopenia
• All have potential impact on:
• Chemotherapy schedules (dose reduction, delays)
• Survival (especially for curative or radical chemo)
• Patient experience, quality of life
• Cost
Neutropenia (leucopoenia)
• Severe neutropenia (SN)
• Febrile neutropenia (FN)
• Potentially life-threatening
• Risk of serious infection, sepsis
• Serious impact on chemo schedules, survival
• 20% patients experience SN or FN after first cycle of
chemo, rising to 30% during cycles 1 to 4 (Lyman et al 2011)
• Cost to NHS of 1 episode of FN ≈ £2,300 – £3,500
• More if patient requires High Dependency Unit
(neutropenic sepsis)
Treatment for Neutropenia
• Granulocytic-Colony Stimulating Factor (G-CSF)
• Primary or secondary prophylaxis
• Chemo regimens where risk of FN is >20%, or
10-20%
• Not indicated for all chemo regimens, cancer
types, or stages of cancer
• Costly
• Self-administered injection
• Side effects:
• Bone pain/aches, other musculoskeletal pain
• Red, itchy skin; fevers, chills; fluid retention;
breathlessness
Chemotherapy-induced anaemia
• High incidence, associated with:
• Lung, gynaecologic malignancies
• Platinum based chemo regimens (lung, ovarian, head & neck
cancers)
• New cytotoxic agents and intensive chemo regimens
• Occurs in 19.5% chemo patients in cycle 1
• Rises to 46.7% in cycle 5 (NCCN 2012)
• Treatments:
• Blood transfusion
• Erythropoiesis-stimulating agents (ESAs)
• Iron supplementation and monitoring
• Associated side effects and cost implications
Thrombocytopenia
• Least worrisome of the
three conditions
• Unless accompanied by heavy
bleeding
• Bruising, nose bleeds,
bleeding gums, heavy
periods
• Usually untreated, other
than observation
• In some cases, platelet
transfusion
How can moxa help?
• Used in classic and modern practice of Chinese
medicine to:
• Stimulate the immune system
• Nourish blood
• May have potential to reduce CIP, affecting
• Incidence/severity of neutropenia, anaemia, thrombocytopenia
• Reduce other side-effects of chemotherapy
• Developing evidence base including:
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Laboratory research (animal)
RCT
Clinical observation, case studies
Anecdotal
Evidence base for moxibustion
• Laboratory studies (animals) report improved immune
cell function (see Zhang & Lao 2012; Wong & Sagar 2010)
• Systematic review of clinical studies (China) reports:
• Higher WBC, platelet counts than control
• Reduced side effects, improved QoL
• Conclusion:
• “low level of evidence” demonstrating superiority of
moxa over controls in management of CIP (Choi et al
2014)
Evidence base
• RCTs:
• USA, ovarian: >leukocyte count; <incidence
leucopoenia in intervention over sham (Lu et al 2009)
• Portugal, colorectal: >WBC, absolute neutrophil
counts, B cells, NK cells; <anxiety, depression in
AcuMoxa group compared to no intervention (Pais et al
2014)
• Clinical reports and case studies (UK)
• Staebler – evaluation of 20 years clinical experience
(2009)
• Davies – case study of self-administered moxa on
ST-36 (2013)
Aims & objectives of this study
• Primary aim
• Assess feasibility of integrating intervention into a typical
chemotherapy schedule:
• 1) patient interest and participation
• 2) adherence to daily procedure over long period of time
• Secondary aims
• Obtain first measure of effectiveness for reducing CIP
• Obtain first measure of impact on completion of chemotherapy
according to schedule
• Collect preliminary data on reduction of other chemotherapy
related toxicities and QoL
• Assess acceptability to a) patients and b) oncology healthcare
professionals (OHPs)
• Monitor adverse events of moxibustion (safety)
Study design
• Phase 0 uncontrolled, observational single arm
feasibility study
• Single site
• Aim to recruit 25 participants
• Mixed methods
• Quantitative data: adherence to moxa protocol; blood
counts; completion of planned chemo schedule; QoL;
patient self-management; safety
• Qualitative: acceptability of intervention to patients
(focus groups) and oncology health professionals
(interview)
Preliminary measures
Adherence to moxa protocol
Daily Moxa Diary
Full blood count
Patient records
Completion of planned chemo
schedule
Patient records
Chemo-related toxicities
Patient notes
Quality of life
FACT-G, FACT- An & N (baseline,
Cycle 1, Cycle 2, Cycle 3, Cycle 6
or final, EOT + 4 weeks
Patient self-management
Patient Activation Measure (PAM)
Safety
Participant report, Daily Moxa
Diary
Inclusion/exclusion criteria (abridged)
• Patients, female or male, age 18 - 75 years
• With breast, gynaecologic, colorectal cancers who are prescribed:
• Radical or adjuvant chemotherapy in the early disease setting, or
• 1st or 2nd line chemo if in the metastatic setting
• About to commence a course of chemo for which G-CSF is not
indicated
• With a life expectancy of >6 months
• Able to understand instructions for self-administration of moxa and
carry out procedure
• Able to give informed consent
• Not suitable for patients with other severe medical problems,
cognitive impairment, haematological cancer diagnosis, receiving GCSF
Intervention: Step 1
• Meeting 1: Up to 10 days prior to first chemo
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Explain concept of moxibustion
Demonstrate procedure
Obtain consent
Teach how to light, use and extinguish moxa safely
Teach how to locate Zusanli ST-36
Mark point with surgical pen
Discuss importance of daily application on bilateral ST-36 (3
minutes each side)
• Show how to record in Daily Moxa Diary
• Supply moxa package
• Supply support materials
Intervention: Step 2
• Meeting 2: One week following meeting 1
• Participant demonstrates handling and application of moxa
• Questions and concerns addressed
• Given full pack of moxa supplies
Moxa protocol
• Moxa daily
• Apply 3 minutes each
point
• Commence 7-10 days
before starting chemo
• Continue
• Throughout full chemo
schedule
• Plus 3 weeks after end
of chemo schedule
• <10 minutes per day
Credibility - three main concerns
1. Within research team
2. With oncology medical professionals:
• ...moxibustion is a bit too far north...”
• “We can get our heads around acupuncture, but
moxibustion we just don’t get ...”
3. Potential participants
• Participants not having regular acupuncture
• Approaching patients “cold”
• Introducing a new, novel intervention at a crisis point
Establishing credibility in research team
• Experiential, rather than
theoretical understanding
• Thorough understanding of
procedure and challenges
• Feedback improved our
approach (moxa, lighters,
extinguishers)
• Increased confidence in
explaining and
demonstrating intervention
• Additional ideas
(mindfulness)
Establishing credibility in NHS setting
• Careful preparation to build positive attitudes
• Rewrote protocol
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Theory & evidence base for ST-36 and moxa
Theory & evidence base for moxa for CIP
Mechanisms of moxibustion
Adverse effects of moxa
Associated costs of treatments
• Informal demonstrations
• Formal meetings
Supporting potential participants
• Participant Information Sheet (PIS)
• Summary of research evidence
cited in protocol
• Detailed instruction leaflet
• Developed by award-winning inhouse information design team
• Meets DoH “Information Standard”
• Video demonstrating procedure
Ensuring adequate participant support
• All support tools available at
http://www.ljmc.org/2_research/projects/moxa.html
• Phone contact for any difficulties
• Emergency number
• Follow up with Health Improvement Practitioner
(HIP) at each chemotherapy treatment
To date:
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Successful first submission to ethics
Recruitment opened 29 February 2016
8 participants to date
Positive, constructive support from oncologists
and chemotherapy nursing staff
• Increasing interest from other OHPs
• Publication:
• de Valois B, Young T, Glynne-Jones R, Scarlett C, Staebler F
(2016) Limiting chemotherapy side effects by using moxa.
European Journal of Oriental Medicine, 8(3):29-39
Challenges
• Recruiting patients 7-10 days before chemo starts
• Amendment to protocol: recruitment up to the end of
first chemotherapy dose
• Competing with other studies
• Working cross-team
• Competing for the attention of busy clinicians to refer
patients
• Presence of HIP at all clinics
• Bright flyers summarising inclusion/exclusion criteria
• Stickers on patient notes
• Building relationships with OHPs
Dr Beverley de Valois
Supportive Oncology Research Team
Lynda Jackson Macmillan Centre
Mount Vernon Cancer Centre
Rickmansworth Road
Northwood, Middlesex
United Kingdom
HA6 2RN
Email:
[email protected]