Effect of a Low Residue Diet in Comparison to the Dietary Recommendations From the INCan: A Randomized Clinical Trial to Assess Malnutrition, Gastrointestinal Toxicity and Quality of Life of Advanced Cervical Cancer Patients (IB2-IVA)

In Mexico, cervical cancer (CC) is the second most frequent cause of death among women, with a mortality rate of 4000 women/year. Among the patients attended by the INCan, 80% are diagnosed with locally advanced CC and 30% of these present comorbidities. Hypertension may be present in 20% of patients, obesity in 18% and diabetes in 6.8%. These comorbidities affect the efficacy of treatment, increase the risk of malnutrition, of adverse events, hospitalization, increase hospital stay and worsen the quality of life, and even increase the risk of death. Furthermore, 10 to 20% of patients present kidney deterioration. The main reason for kidney disease is ureteral obstruction. The glomerular filtration rate deteriorates with age and many patients have comorbid medical illnesses that further compromise the kidneys. The standard treatment for CC is concomitant chemo-radiotherapy using cisplatin as a radiosensitizer, and brachytherapy at the end of treatment. Studies developed in the INCan described the acute toxicity symptoms in CC patients using this treatment: nausea, vomiting, diarrhea, cystitis, radioepithelitis, leucopenia, neutropenia, thrombocytopenia. Pelvic radiotherapy causes gastrointestinal toxicity, which is the most important limiting factor for the patients to complete their treatment. Cancer treatment, along with the tumor itself and other factors, causes malnutrition, and this confers a bad prognosis for the patient's response to treatment and survival. There is a nutritional risk in these patients at the moment of diagnosis, because of the metabolic alterations caused by the tumor, and the treatment-induced side effects. International guidelines for cancer patients recommend nutritional assessment in these patients before they start treatment, so nutritional risk can be detected and the patient may get started on dietary intervention to prevent malnutrition. Several authors have studied the dietary management that may help reduce the gastrointestinal effects in cancer patients receiving pelvic radiotherapy. To reduce diarrhea and prevent malnutrition the recommended dietary approach is a low residue diet consisting on 20-25% fat, 5g of lactose and 20g of fiber. Currently the INCan does not follow the nutrition care process for cervical cancer patients; written recommendations are given to the patients with a list of foods allowed or not allowed, with no further nutritional assessment or intervention. The investigators described the nutritional status of CC patients undergoing concomitant chemo-radiotherapy. It was observed that by the end of cancer treatment, a period of 9 weeks, 81.8% of patients became malnourished; 96% of patients lost weight, 78% of which had severe weight loss.

The aim of this clinical trial is to evaluate a diet low in residue in CC patients, considering the necessary modifications for each patient if morbidities are present, in comparison with the current dietary recommendations used in the INCan. A thorough nutritional evaluation including anthropometric data, dietary data, gastrointestinal toxicity and quality of life evaluations, will be performed.

Particular objectives are the following:

1. Identify the nutritional status of CC patients before, during and after treatment with chemo-radiotherapy, in intervention and control groups.
2. Determine the association of malnutrition and gastrointestinal toxicity during and after treatment, in intervention and control groups.
3. Evaluate the quality of life of patients before, during and after treatment, in both groups.
4. Establish the association of nutritional status and response to treatment, in both groups.

The aim is based on the following hypothesis: Patients receiving the personalized nutritional intervention with the low residue diet will maintain a better nutritional status during treatment, reflected in fewer malnourished patients, compared to the control group.