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

Summary

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.

Conditions

• Uterine Cervical Neoplasm
• Dietary Modification
• Radiation Toxicity
• Gastrointestinal Complication

Interventions

OTHER

Dietary modification

Dietary intervention will consist on a low residue diet: 20% kcal from fat, 5g lactose/day, 20g fiber/day (5g from insoluble fiber). Dietary intervention will be adapted to the patient's individual requirements, according to the presence of comorbidities or renal deterioration. 1. No comorbidities. Energy: 20-30 kcal/kg of body weight/day. Protein: 1.3 g/kg of body weight/day. 2. Comorbidities (diabetes, hypertension), or geriatric patient. Energy: 25-30 kcal/kg of body weight/day. Protein: 1.5 g/kg of body weight/day. 3. Renal deterioration. Energy: 30-35 kcal/kg of body weight/day. Protein: 1 g/kg of body weight/day. Sodium: 2000-2300 mg/day. Potassium: 1900-2730 mg/day. Phosphorus: 800-1000 mg/day.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  collaborator OTHER

• National Institute of Cancerología

  lead OTHER_GOV

Principal Investigators

• Lucely C Cetina, MD, MSc · National Institute of Cancerología

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-01

Primary Completion

2020-11-30

Completion

2021-09-01

Countries

• Mexico

Study Locations