Information about the clinical trial conducted at our centre for people experiencing unexplained weight loss related to cancer
Our centre took part in Pfizer’s PROACC-1 study - a Phase II, randomised, double-blind, placebo-controlled clinical trial with an optional open-label treatment period, which aims to evaluate an investigational drug ( ponsegromab ) in people with cachexia associated with non-small cell lung cancer ( NSCLC ), pancreatic cancer or colorectal cancer.
Who can take part in the study?
People who meet the following criteria may take part in the study:
- unexplained weight loss associated with non-small cell lung cancer ( NSCLC ), pancreatic cancer or colorectal cancer ( with no other cause of weight loss )
- aged 18 or over
- no other conditions causing reduced food intake, and not being tube-fed
- no major surgery in the previous 4 weeks and no planned surgery
Other criteria also apply, which the study centre team will discuss with the patient if they are interested.
How long will participation in the study last?
The PROACC-1 study will last a maximum of 72 weeks, during which participants will attend about 21 visits. After a 4-week screening period, participants will receive two subcutaneous injections of ponsegromab or placebo - every 4 weeks, for 12 weeks, during the double-blind treatment period. After that, all participants will have the option of receiving ponsegromab at a dose of 400 mg ( the highest dose ) for a further 52 weeks during the open-label treatment period. The final visit ( a safety follow-up visit ) will take place 8 weeks after the last dose of the drug ( follow-up period ).
The study drugs and all related procedures are, as a rule, provided free of charge. All costs associated with taking part in the study will be covered.
What is a placebo?
An inactive substance or intervention ( therapy ) that has no effect on the patient’s health. A placebo contains no active ingredients, but looks the same as the investigational drug.
Study safety!
The safety of study participants is the top priority in every clinical trial. Before joining, the patient will receive detailed information about the study, including the potential benefits and risks of taking part. During the study, the patient’s health will be monitored by the study team. The patient may withdraw from the study at any time and for any reason.
What is cancer cachexia?
Cancer cachexia is a syndrome of metabolic disturbances in the body that result from cancer. It is the second of the three stages of cancer-related wasting (the first is pre-cachexia and the third is refractory cachexia). This condition is associated with a poor prognosis and with possible exclusion from cancer treatment, caused among other things by sudden weight loss.
The symptoms of cachexia include sarcopenia, i.e. significant loss of muscle mass, reduced immunity and general weakness, as well as loss of appetite. It is also associated with reduced physical fitness, which in turn makes everyday functioning more difficult. It can also result in anaemia and a fall in the white blood cell (leukocyte) count, albumin and total protein levels. A characteristic symptom of cachexia is loss of energy, which may result in asthenia - chronic fatigue. This leads to a sense of isolation and loneliness, and a feeling of being excluded from social life.
Cancer cachexia is often associated with an aversion to food, which in the longer term may lead to the development of the cachexia-anorexia syndrome.
Cachexia must therefore always be treated, in order to improve the prognosis and the patient’s chances of survival. But how?
At present, the only effective way of treating cachexia is to cure its source - the cancer itself. The first step is to relieve symptoms that affect eating, such as nausea, diarrhoea and constipation. Next, the patient’s nutrition should be supervised by an oncology dietitian. The dietitian’s role is to show the patient that, in addition to the nutritional value it provides, food also gives pleasure and can become a form of social activity (which, as we know, is one of the basic and most complex problems in cachexia).
Tips for patients struggling with cancer-related wasting may include: eating small meals at short intervals, light physical activity before a meal, e.g. a walk, and adapting the consistency of food to the patient’s condition.
Cachexia can also be treated with medication, e.g. corticosteroids, progestogens or cannabinoids.
It is said, however, that prevention is always better than cure. So, where possible, it is worth adding oral nutritional supplements ( foods for special medical purposes ) to the diet; besides being rich in vitamins, micro- and macronutrients, they contain a large number of calories in a small volume.
It is worth remembering, however, that the most important factor in a patient’s recovery from cachexia is the support of their loved ones. It is this support that gives them the strength to fight the disease.
Trial participants can contact the centre’s staff:
Beata Wydmańska – study coordinator, tel.: +48 501 499 366.