Effect of a Low Residue Diet in Comparison to the Dietetic Recommendations From the INCan in Cervical Cancer Patients

In Mexico, cervical cancer (CC) ranks second in incidence and mortality among women. The National Institute of Cancer in Mexico (lNCan) receives annually about 500 patients with CC, 80% of which are diagnosed with locally advanced disease. The standard treatment for locally advanced disease consists in concomitant chemo-radiotherapy based on cisplatin (QT-RT), followed by brachytherapy, with an absolute benefit of 10%. Adverse effects include gastrointestinal toxicity, which is the most important factor limiting the dosage of pelvic radiation. Cancer treatment, in any modality, induces malnutrition, more so when combined treatments are administered. Radiation induced gastrointestinal toxicity is caused by different factors, among which are malabsorption of bile, fat and carbohydrates, decrease in brush border enzymes, diverticular disease, proctitis, and psychological factors. 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% kcal from 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. From previous studies, the investigators have demonstrated that the current recommendations do not help the patients maintain their nutritional status, during their treatment most patients become malnourished (81%, p\<0.01). Therefore, 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.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Women 18 years of age and older.
* Ability to understand the study and be able to sign the informed consent.
* Functional stage ECOG 0 - 2.
* Negative pregnancy test, null reproductive potential, or currently using an contraceptive method.
* Willing and able to attend the programmed visits.
* Diagnosed with cervical malignant tumors of epithelial origin in the neck of the uterus, clinical stages IB2-IVA.
* Candidates to receive concomitant Chemo-Radiotherapy, followed by Brachytherapy.
* In case of presence of diabetes mellitus and/or hypertension, without retinopathy or albuminuria \<300 mg/dl.
* In case of renal deterioration, a creatinine clearance \>20 ml/min.
* Hemoglobin \>10 g/l.
* Leucocytes \> 4000/mm3.
* Platelets \>100000/mm3.

Exclusion Criteria:

* Under a different nutritional treatment using a nutritional supplement.
* Carrying other uncontrolled diseases, including cardiovascular insufficiency, arrhythmia, psychiatric illnesses.
* Concomitant treatment with another experimental drug.
* Active TB.
* Infected with HIV.
* History of LES and other rheumatologic diseases that involve renal deterioration.
* Presence of vesicular-vaginal fistulae at moment of diagnosis.
* Previous malignancy.

Study Discontinuation Criteria:

* Loss of follow up for 21 days.
* Evidence of disease progression.
* At the request of patient.
* By unacceptable toxicity.
* Pregnancy.

Criteria must be followed punctually. If a patient were inappropriately included, she must be discontinued from the study.

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