Proposal Information
for Osteosarcoma Trial
in Dogs

Canine Osteosarcoma Trial 2018


Geoff Johnson  MA Vet MB MRCVS. VetFFHom. RSHom. PCH

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Canine Osteosarcoma Trial 2018

This is a research trial where Homeopathy is given in addition to standard veterinary painkillers for those dogs where amputation and chemotherapy have been decided against. There are 20 places left on the trial as of June 2018. Below is an in depth explanation of the trial. If you would like your dog to be considered, contact osteosarcomatrial@yahoo.com. The trial is free.

Osteosarcoma dog

Research Proposal

An observational study of canine appendicular osteosarcoma in dogs receiving homeopathy as an adjunct to conventional treatment.

Principal investigator
Geoff Johnson MA Vet MB MRCVS. VetFFHom. RSHom. PCH
Address: Wiveliscombe Homeopathic Veterinary Surgery,
12 North Street, Wiveliscombe, Somerset TA42JY
01984 624999 • osteosarcomatrial@yahoo.com

Summary

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.

Geoff Johnson


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.

Geoff Johnson

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
osteosarcoma are:

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 Investigators
Other homeopathic vets who are members of the BAHVS may also participate in the osteosarcoma trial if the owner is unable to transport the dog to Somerset.

Osteosarcoma

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.

Osteosarcoma in dog's front leg

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.

Osteosarcoma trial design

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.

Inclusion criteria

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.

Exclusion criteria

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.

Osteosarcoma dog

Ethics

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.

Methods

homeopathic consultation

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.

Outcome measures

Primary

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.

Power calculation

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.

References – click to read


Want to know more?

Statistical analysis of osteosarcoma trial

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.

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