Case Studies

SIDE EFFECTS

There have been remarkably few side effects attributable to the interventions in the CAPP studies. One patient in Hong Kong withdrew after complaining of bleeding gums, which was presumably due to the anti-platelet effect of the aspirin in someone with poor dental hygiene. The starch supplements have not had a major impact in terms of side effects although a number of participants have complained of constipation which may be a combined effect of resistant starch intake and poor fluid intake. It is our impression that if the resistant starch supplement is introduced slowly, the side effects of bloating and constipation are dramatically reduced.

It is also worth noting that patients taking the placebo starch have also complained of similar symptoms so these may be simply a consequence of a change in diet rather than a chemical effect of the resistant starch itself.

Blood Transfusions and Clinical Trials in the UK

The UK Blood Transfusion Service has a blanket “no blood” policy for anyone taking part in a clinical trial. This has proved to be difficult for one of our recruits who wished to do both.

The advice we would give is:

a. the recruit is doing a great service to cancer research by taking part in this trial and that is an enormous contribution. b. if the recruit does wish to do both: if they stop taking CAPP2 treatments for 1 week prior to giving blood then all trace of the interventions should be out of their system and not affect any blood they give. Once blood has been given they can restart CAPP and this will not affect their compliance or overall participation.

CAPP2 and Lactose Intolerance

A PI wrote in to ask for advice on the possibility of a patient with lactose intolerance taking the starch supplements.

Our nutritional expert replied “there are no additional concerns about taking the starch supplements for this recruit. The starch does not contain any lactose”.

CAPP2 and Diabetes

The query raised concerned the possible contraindications from the study treatments for a recruit with coeliac disease.

Our nutritional adviser commented that:

 “the starch we use is made from high amylose maize and should therefore have no implications for someone with coeliac disease. As regards the aspirin I am not aware of any adverse effects of aspirin on coeliac disease”.

National Starch & Chemical Co, who provide the starch intervention, wrote to advise us that “the starch products we supply are refined from dent corn, waxy corn or tapioca. Coeliac disease is an allergic reaction to certain amino acids found in the protein of wheat and rye flours (wheat gluten). Wheat and rye flours have a protein content ranging from 5% - 14%. The food starches we supply typically have a protein content of less than 0.5%. In addition to the low amount of protein present in corn and tapioca starch, the types of amino acids are not identical with those found in wheat or rye flours and they are therefore not associated with coeliac disease”.

CAPP2 and Coeliac Disease

The query raised concerned the possible contraindications from the study treatments for a recruit with coeliac disease.

Our nutritional adviser commented that “the starch we use is made from high amylose maize and should therefore have no implications for someone with coeliac disease. As regards the aspirin I am not aware of any adverse effects of aspirin on coeliac disease”.

National Starch & Chemical Co, who provide the starch intervention, wrote to advise us that “the starch products we supply are refined from dent corn, waxy corn or tapioca. Coeliac disease is an allergic reaction to certain amino acids found in the protein of wheat and rye flours (wheat gluten). Wheat and rye flours have a protein content ranging from 5% - 14%. The food starches we supply typically have a protein content of less than 0.5%. In addition to the low amount of protein present in corn and tapioca starch, the types of amino acids are not identical with those found in wheat or rye flours and they are therefore not associated with coeliac disease”.

CAPP2 & GM

As a result of the above query it was also confirmed that the starch is NOT genetically modified.