Changes in body composition during and after external beam radiotherapy for gynaecologic cancer

Cancer treatment aims to eradicate or control the disease with minimal loss of
quality of life during and after treatment. Cancer-associated malnutrition is a
common problem affecting the majority of all cancer patients. Malnutrition
causes significant morbidity and mortality in cancer patients. It is associated
with an increase in toxicity, a decreased survival, poor response to cancer
therapies, reduced quality of life and impaired functional abilities in cancer
patients.

However, these effects have not yet been investigated in gynaecological cancer
patients receiving external beam radiotherapy (EBRT).
The only study including body composition found that women had a significant
lower fat free mass (a reduction of 4,5 percentage point between baseline and
follow up) and higher fat mass during follow up in 15 patients treated with
curative radiotherapy for gynaecological cancer.

In clinical practice the worsening nutritional status during radiotherapy of
women treated for gynaecological cancer is clearly visible. Moreover, the
number of patients who are unable to return to their normal activities after
treatment during the first year of follow up is considerable. It is our
hypothesis that weight loss and loss of muscle mass during radiotherapy are
related to the fatigue and inability to recover fully from the treatment.

Therefore, our aim is to perform an exploratory pilot study to assess body
composition and social participation before, during-, and after external beam
radiotherapy for gynaecological cancer

The primary objective of this study is to assess if clinically relevant changes
occur in fat free mass (FFM) between baseline and follow up six months after
the end of treatment.

Our cut-off value of a clinically relevant difference in body composition
justifying further exploration is defined as: one in three women have a
reduction of *4.5 percentage point in FFM (of total body weight) at the
six-month of follow up compared to baseline.

Exploratory observational pilot-study.

The EORTC, SNAQ and PROMIS questionnaires are currently distributed as part of
the regular treatment evaluation. There are no additional hospital visits
needed. Standard of care already includes a baseline CT-scan. Thus, three
additional non-contrast CT-scans are scheduled as part of the study procedures.
The total maximum of additional radiation exposure is 5 mSv (<0.01% compared to
the radiation exposure as part of the treatment for these patients). The
measurements are all non-invasive. The skinfold measurement can cause temporary
pain and bruising.