Yeah, sure. So starting, so we had planned this study back in 2024. So we observed that cancer anorexia syndrome leading to weight loss and the loss of appetite. It is quite prevalent mostly in the later stages like CS, stomach, HPV cancers. So certain specific types have got a higher propensity of weight loss and the loss of appetite. And it is as high as in patients to around 60 to 70% of the cases...
Yeah, sure. So starting, so we had planned this study back in 2024. So we observed that cancer anorexia syndrome leading to weight loss and the loss of appetite. It is quite prevalent mostly in the later stages like CS, stomach, HPV cancers. So certain specific types have got a higher propensity of weight loss and the loss of appetite. And it is as high as in patients to around 60 to 70% of the cases. So traditionally, they have been using megastrol acetate, which is a steroid congenor, for the treatment of specific sorts of this kind of indication during chemotherapy. The doses used to be ranged around 400 to 800 milligrams per day. But the problem with this megastrol acetate was that being a steroid congenor, it used to cause raised blood sugar levels. And also it was the responsible drug for causing a significant number of VTEs, that is venous thromboembolism. So there was an alternative to this, a low dose of olanzapine, which is basically an antipsychotic drug. So there was a study from India back in 2023. That study had shown the efficacy of a low dose of olanzapine. Again, that study was basically placebo-controlled. But till date, there was no active study doing the sort of a head-to-head comparison between a low dose of olanzapine versus the mostly used sort of a drug that is megastrol acetate. So we had planned this study to have a comparative study between these two drugs. And so we had taken 77 patients in each of the groups. So the sample size was basically calculated depending on a previous study. And so this study was not formally sort of randomized. So what we had done is every alternate patient walking into our OPDs who had a significant complaint of loss of appetite. So we had put all those patients, alternatively, to either a low dose of olanzapine, that is 2.5 milligrams per day during the entire course of systemic cytotoxic chemotherapy for three months. And the other group had received megastrol acetate 160 milligrams three times a day for three months. So the primary endpoint was the proportion of patients achieving more than 5% of the weight gain. This was the primary endpoint. And the secondary endpoint was the proportion of patients who had achieved more than 37 in the score of FACT-ACAS, which is sort of an objective score line. And we had also estimated the proportion of patients who had achieved more than three points in the improvement of the loss of appetite in a sort of a subjective numerical score. So the score stays like this, that the score is ranged between 0 to 10, 0 being very good appetite and basically 10 being very poor appetite. So what we found was that both the groups were more or less equally matched. We had CA pancreas as the most number of patients in the study around 30 to 36 percent in each of the groups followed by CA gallbladder and then lung cancer. And the median, so we had taken the mean weight. So the mean weight during the onset of the study was around 63.22 in the low-dose olanzapine arm and it was 62.84 in the megastrol arm. So after the intervention, the mean weight in the low-dose olanzapine was around 63.47 and in the megastrol arm was 62.84, both being non-significant statistically. So as far as the final result came was that around 47% of patients in the olanzapine arm had a raised body weight increase by at least 5% or more. As compared to the megastrol, it was around 40%. And in terms of FACT-ACS score, we had seen that around 27% of the patients had achieved improvement in the FACT-ACS score, which was sort of an objective score. So around 27% of patients in the olanzapine versus around 26% of patients in the megastrol had achieved improvement in the FACT-ACS score. And in terms of the subjective score, around 41% of patients in the olanzapine had basically improvement by 3.0 as compared to around 36% of patients in the megastrol arm. So we had basically concluded that in terms of efficacy, both low-dose olanzapine and sort of megastrol acetate were more or less similar in terms of efficacy. Though we do not right now have the adverse effect data, but on the basis of the historical studies and so on, so we had opined that low-dose olanzapine seemed to be faring better in terms of adverse effects, especially during chemotherapy, because this drug is also indicated for the treatment of chemotherapy-induced nausea, vomiting. The dose range is around 2.5. It may go up to a maximum around 10 mg per day. So for this, the same drug can be used both for CAS, that is sort of an anorexia syndrome, and also for the treatment of chemotherapy-related nausea-vomiting. As compared to megastrol acetate, which is a steroid congenor, which has got the adverse effects of raised blood sugar levels, which anyway can happen during chemotherapy because during chemotherapy, we use a lot of steroids as well as a measure of chemotherapy-induced nausea-vomiting. So, in terms of efficacy, we opined that both these drugs may be compared, but in terms of safety, though we do not have taken the safety data in this study, which is basically ongoing. But in terms of safety, low-dose olanzapine seems to be doing a bit better as compared to megastrol acetate, especially during chemotherapy.
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