Protein intake in patients with colorectal or lung cancer during first line treatment with chemo(radio)- or immunotherapy when receiving a low volume, energy dense and high protein oral nutritional supplement: a randomized, controlled study

There is a strong body of evidence showing that cancer-related malnutrition,
and in particular muscle wasting, is a negative prognostic factor for quality
of life, response to treatment and occurrence of chemotherapy toxicities as
well as survival. Malnutrition results from the combination of reduced food
intake and increased catabolism in cancer patients. Therefore, maintaining a
sufficient energy and protein intake during treatment is key. Achieving protein
intake recommendations is challenging for many patients undergoing treatment.
Patients may benefit more from a protein-dense nutritional supplement to
support nutritional intake, and more specifically protein intake during
treatment.

The primary study objective is to assess protein intake at the end of the first
treatment cycle in patients with CRC or NSCLC undergoing first line treatment
with chemo-, concurrent chemoradio- or immunotherapy who are receiving two
servings of test product daily and who completed the study until the end of the
first treatment cycle compared with standard of care.

Secondary objectives of this study are:
in patients with CRC or NSCLC undergoing first line treatment with chemo-,
concurrent chemoradio- or immunotherapy who are receiving two servings of the
test product daily or who are receiving standard of care:
- To study the proportion of subjects with a protein intake above the lower
limit of the ESPEN recommendations for protein intake for cancer patients at
the end of the first treatment cycle
- To study the effect of the test product on body weight during 12 weeks

Exploratory objectives are in these patients:
• To assess protein intake at the end of the second or third treatment cycle
(depending on the duration of a treatment cycle), i.e. after 6-8 weeks of
treatment
• To study the proportion of subjects with a protein intake above the lower
limit of the ESPEN recommendations for protein intake for cancer patients at
the end of the second or third treatment cycle (depending on the duration of a
treatment cycle) and after 12 weeks of treatment
• To gain insight on:
o Dietary intake and factors impacting dietary intake over the course of
treatment
o Taste and smell changes
• To study the effect of the test product on:
o Health-related quality of life
o Performance status
o Treatment adherence and dose-limiting toxicities
o Body composition (optional, when data are available from routine clinical
care)

This is a randomised controlled, open label, parallel-group, multi-center and
multi-country study. A 2:1 randomisation will be applied.

The test group will be receiving daily 2 servings of a low volume, energy dense
and high protein oral nutritional supplement during 12 weeks of first line
treatment. The control group will be receiving standard of care.

Patients in the test group will be asked to take the medical nutrition
supplement (test product) twice daily during the first 12 weeks of their first
line anti-cancer treatment. They will start taking the test product at least 1
but preferably 4 or more days before the start of the first treatment cycle.
The control group will receive standard of care. Patients in the control group
will undergo the same assessments as patients in the test group. Most of the
study assessments are performed during routine hospital visits required for the
treatment of the disease. In addition, some of the assessments will be done at
home. Study specific assessments are: daily recording of test product intake in
a diary (for the test group only) and completing 3-day and 1-day food diaries,
questionnaires to record factors impacting nutritional intake, gastrointestinal
symptoms, quality of life and taste and smell changes. Based on literature, no
specific adverse effects are expected. Adverse events, treatment adherence and
dose-limiting toxicities will be evaluated.