PROPOSAL INFORMATION FOR OSTEOSARCOMA TRIAL
An observational study of canine osteosarcoma in dogs receiving homeopathy as an adjunct to conventional treatment.
An observational study of canine appendicular osteosarcoma in dogs receiving homeopathy as an adjunct to conventional treatment.
Geoff Johnson MA Vet MB MRCVS. VetFFHom. RSHom. PCH
Address: Wiveliscombe Homeopathic Veterinary Surgery,
12 North Street, Wiveliscombe, Somerset TA42JY
01984 624999 • firstname.lastname@example.org
An observational study of 30 dogs suffering from appendicular osteosarcoma receiving homeopathic treatment as an adjunct to conventional treatment. The survival times for dogs receiving homeopathy plus conventional treatment will be compared to established survival times of dogs receiving conventional treatment only (1,2,3,4). Survival time means from diagnosis by imaging following clinical examination to euthanasia.
This study will set up systematic scrutiny of treatment outcomes of 30 dogs referred by veterinary surgeons with a confirmed diagnosis. Whilst no causative link between treatment and outcomes can be drawn from an uncontrolled trial, observational studies can provide useful information about what is occurring in practice (7). However results will be interpreted with caution, as higher numbers of participants are needed to overcome random effects in estimating the direction and magnitude of treatment effects.
Qualified as a veterinary surgeon in 1987, and subsequently qualified in veterinary homeopathy 1999. He is the principal of a busy homeopathic veterinary surgery in West Somerset. He lectures frequently at home and abroad. He wrote the curriculum and taught the Danish Homeopathic Veterinary Diploma.
He is one of the few UK vets who treat animals diagnosed with cancer using homeopathy (5,6). He lectured conventional vets on this subject at the SW and London Vet Shows in 2014.
Potential impact on homeopathic veterinary research
If the results obtained with dogs previously treated with homeopathy by the PI can be replicated (5,6), then it may become clear that homeopathy could offer potential for extending life for dogs diagnosed with canine osteosarcoma.
The PI’s aspirations for research into homeopathic treatment of dogs diagnosed with
To improve the quality of life and to extend the life expectancy of dogs diagnosed with osteosarcoma.To provide further evidence of the efficacy of homeopathy in serious life threatening clinical conditions where conventional therapy alone may have limited success.
Other homeopathic vets who are members of the BAHVS may also participate in the trial if the owner is unable to transport the dog to Somerset.
Osteosarcoma is the most common primary bone tumour found in dogs. It accounts for up to 85% of all malignancies originating in the skeleton. It mostly occurs in middle aged to older dogs, with a median age of 7 years. The average survival time for dogs suffering from appendicular osteosarcoma treated with surgery and chemotherapy is approximately one year (1,2,3,4).
A median survival time of seven months was reported for dogs receiving radiation therapy along with chemotherapy; whereas a combination of surgery and chemotherapy showed more encouraging median survival rates of 235-366 days with up to 28% surviving two years after diagnosis (4). Dogs between seven and ten years of age have greater survival rates than younger and older dogs.
In axial osteosarcoma, the medial survival rate is four to five months because of the likely recurrence of the disease, and complete surgery is not possible because of the location (4). This trial does not include dogs with axial osteosarcoma.
Objectives of the study
The objective is to systematically record the life span of dogs diagnosed with osteosarcoma receiving homeopathy as adjunct care to palliative analgesia, and to compare these results with the most authoritative data available on conventional survival times where palliative analgesia only was employed. The results will be written up and submitted for publication to a peer review science publication.
Observational study of individualised homeopathic treatment of 30 dogs referred by veterinary surgeons with confirmed diagnosis of osteosarcoma. The study is due to close after 24 months, but this time may be extended if recruitment is slow.
Dogs with diagnosis of osteosarcoma confirmed in the last six weeks by the referring vet. Diagnosis of osteosarcoma will be confirmed by a specialist vet’s report based on clinical signs and imaging. Histopathology results will be recorded but are not mandatory.
Dogs in the study will be receiving conventional palliative treatment from the referring veterinary surgeon, as would occur in practice.
Dogs on palliative conventional treatment only i.e. painkillers such as NSAIDS and opiates. Owner’s agreement to attend one consultation (minimum) at Wiveliscombe with the dog, and to provide feedback on the dog’s progress.
Concurrent disease, reported by owner or referring vet or identified during physical examination, that is likely to prevent the dog from living one year, and dogs with evidence of gross metastatic disease.
This study observes routine practice with no additional risk to dog or owner. Procedures are in place to ensure that observation for research purposes is conducted according to the highest ethical standards.
A QOL monthly questionnaire has been added to the requirements for participation.
In January 2016 the PI contacted the RCVS RVP and ethical panel with a suggested double blind trial using standardised homeopathic prescribing according to the Banerji protocols. This was rejected. The PI contacted the RCVS again in July 2016 with a proposal for a trial using individualised homeopathy. After a confirmatory mail nothing more was heard.
The trial was commenced January 2017. The trial was submitted again to the new ethics review panel (ERP) in June 2017 and confirmation received in July 2017. A response with suggestions to improve trial design was received from the ERP in March 2018, which is currently being considered
All referrals will be made direct to the PI who will interview the owner over the phone or by email and the PI will complete a pre-entry assessment (to include diagnostic information regarding site and size of primary tumour, QOL, metastases, and conventional treatment).
At this stage the PI will answer owner’s questions.
Owners of all dogs meeting the inclusion criteria will be invited to attend the surgery for a 90 minute consultation with the dog and to supply a copy of the specialist and referring vets' report.
The pre-entry assessment will be checked at the start of the consultation. Dogs not meeting the inclusion criteria will be offered appropriate care or referral. The most appropriate homeopathic remedies will be prescribed for each individual case, according to the principles of homeopathy.
After first and second consultations, telephone and/or email contact will be maintained to ensure continuity of treatment. It is anticipated, subject to clinical need, that the second consultation will be conducted approximately four weeks after the first. Further consultations will be offered according to clinical need or for review.
A follow-up form will be sent to owners who cease contact before the dog’s death.
All dogs will continue under the care of the referring vet, who with the owner will remain in charge of the decision making regarding euthanasia. A monthly check-up of the dog will be suggested with the referring vet for all cases commencing treatment after April 2018.
Survival time (ST) defined as the time from diagnosis by imaging until death or euthanasia.
These results to be compared with current data available on ST for conventional treatment regimes.
STs are available from these authoritative sources (1,2,3,4). These resources will be reviewed and updated before commencing data analysis. Comparative data will take into account variables such as site, size of tumour, metastases, and age of dog.
A concurrent cohort of dogs receiving conventional palliative treatment only is being sought. This will enable further comparison with trial participants, to supplement the comparison with established published values.
Quality of life (QoL) in cancer care is a very important aspect of welfare and validated tools are available. Such measurements have been included in this study from April 2018.
This observational study builds on the existing anecdotal evidence. With this level of evidence and for the purposes of an uncontrolled study, a power calculation is not possible. N=30 is a pragmatic figure based on the feasibility of recruitment and management of the cases.
The results will be tabulated. Time from diagnosis by imaging following clinical examination to euthanasia will be compared to the most authoritative data available on conventional survival times, subject to variables such as site and size of tumour, metastases, and age of dog.
Proposed: Kaplan–Meier survival curves (ref Bergman 1996, Vail 2002, Selmic 2014, London 2015). and Cox proportional hazards regression (ref Selmic 2014, London 2015) to be used to compare survival times (ST) with current data available for conventional treatment regimes. If sufficient numbers of participants enter the study with histopathology results, their results will be analysed as a sub-group.
(1) https://www.fitzpatrickreferrals.co.uk/conditions/canine-osteosarcoma/Fitzpatrick Referrals was founded in 2005 by Professor Noel Fitzpatrick and is the UK’s pre-eminent and largest dedicated small animal orthopaedic and neuro-surgical facility, employing over 200 veterinary professionals and comprising state of the art surgical, diagnostic and rehabilitation facilities. This article explains osteosarcoma, and gives survival times as follows; Amputation and chemotherapy – 10 to 12 months, limb spare and chemotherapy – 10 to 12 months; radiation and chemotherapy – 8 to 10 months; amputation alone – 4 to 5 months; palliative care – 1 to 3 months.
(2)http://vetspecialists.co.uk/factsheets/Oncology_facts/Canine_Osteosarcoma.htmlDavies Veterinary Specialists is one of the largest and most diverse small animal veterinary referral centres in Europe employing more than 35 specialist clinicians, 60 nurses (many with an advanced nursing qualification), and 30 administrators and support staff. This site explains osteosarcoma, its diagnosis, treatment and prognosis. Stated survival times are; palliative therapy average survival time is approximately two months; if amputation is performed the average survival time is increased to six and a half months; palliative radiation and chemotherapy have an average life expectancy of six months; amputation with chemotherapy makes the average survival time just a little less than one year.
The Modiano Lab at the University of Minnesota is working to find the causes for cancer, to understand the mechanisms that drive tumour behaviour and tumour progression, and, ultimately, identify the targets that will allow them to prevent, control, and treat different types of cancer. In partnership with the University of Minnesota's Masonic Cancer Centre, they are also working to determine how cancers that occur in animals are similar to cancers that occur in humans, so that they can apply what they learn from our companion animals to people, and vice versa. This article explains the diagnosis, treatment and prognosis of canine osteosarcoma. It states the median survival time using chemotherapy combinations and amputation is 14 months.
(4) Szewczyk, M., Lechowski, R., & Zabielska, K. (2015) What do we know about canine osteosarcoma treatment? Veterinary Research Communications, 39(1), 61–67.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4330401This article is written by M. Szewczyk, R. Lechowski, and K. Zabielska from the Department of Small Animal Diseases, Faculty of Veterinary Medicine, Warsaw University of Life Sciences, Nowoursynowska 159c, 02-787 Warsaw, Poland. The article draws on numerous references, describes osteosarcoma in its various forms, the risk factors associated with development, the diagnosis, various treatment options, and survival times. To sum up, 72% of dogs with appendicular osteosarcoma treated by amputation alone died or were euthanized because of metastases after 138 days (from diagnosis). Dogs treated with amputation and chemotherapy had a median survival time of 307 days.
(5) Johnson, G. ( Interhomeopathy July 2014) The homeopathic treatment of cancer for animals. http://www.interhomeopathy.org/the-homeopathic-treatment-of-cancer-for-animals This article written by Geoff Johnson (PI), presents three of his cancer cases; Canine stomach lymphoma diagnosed by specialist referral centre, treated with Gadolinium arsenate leading to complete remission after 3 weeks, with the dog asymptomatic after three years. Canine oral epitheliotrophic T-cell lymphoma, diagnosed by specialist referral centre, treated with Aurum muriaticum and Kalium chlorosum, leading to full remission within 6 months and the dog asymptomatic after five years. Canine squamous cell carcinoma of the palate diagnosed by specialist referral centre treated with Symphytum 200c leading to dramatic reduction of tumour, as evidenced by the photographs. The dog, having been offered euthanasia, survived nearly 18 months before being euthanised because of a seizure.
(6) Johnson, G. (2011) A Case of Osteosarcoma. Veterinary Times. This article written by Geoff Johnson (P1) presents one canine osteosarcoma cancer case. The dog presented from the primary vet with lameness and radiographic diagnosis of osteosarcoma and a prognosis of three months. Phosphoric acid 200c was prescribed, and the dog survived 22 months, when the lameness recurred and the owner opted for euthanasia.
(7) Spence, D., Thompson, A., Baron, B. (2005) Homeopathic Treatment for Chronic Disease: A 6-Year, University-Hospital Outpatient Observational Study. The Journal of Alternative and Complementary Medicine 11(5), 793–798.This article records the outcome of homeopathic treatment in over 6000 people treated at the Bristol Homeopathic Hospital.