Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer

Summary

During radiation therapy (RT) to pelvic tumors, the small intestine, colon and rectum are inevitably included in the radiation field and are healthy tissues that suffer damage as an adverse effect. Pelvic radiation disease (PRD) is the group of gastrointestinal symptoms experienced by patients that receive pelvic radiation. Intestinal inflammation, tissue damage, oxidative stress and tumor metabolism lead the patient to a catabolic state associated with an increase in energy demands. Also, the painful abdominal symptoms restrict the patients' food intake, leading the patients that develop PRD to an increased risk to develop protein-energy malnutrition and micronutrient deficiencies, all of which affect the patients' quality of life. Studies developed in patients with inflammatory bowel disease have suggested that probiotics may have an anti-inflammatory effect in the intestine. In addition, micronutrients and trace elements provide antioxidant capacity and exert immune-modulating effects during periods of intestinal inflammation. Thus, probiotics and immune-modulating nutrients may provide a means to diminish intestinal inflammation and symptoms associated with PRD. In this project the investigators propose that the nutritional management of cervical cancer patients be based on an anti-inflammatory diet, taking into account the nutritional status, age, comorbidities that the patient may present and symptoms developed during treatment. The nutritional intervention will include food rich in immune-modulating nutrients: omega-3 fatty acids, soluble fiber, antioxidants and polyphenols, and probiotics.

Conditions

• Cervical Cancer
• Uterine Cervical Neoplasm
• Pelvic Inflammatory Disease
• Radiation Toxicity
• Diet Modification

Interventions

OTHER

Omega-3 fatty acids

Diet will include foods rich in omega-3 fatty acids.

OTHER

Antioxidants

Diet will include foods rich in antioxidant vitamins, trace elements, and polyphenols.

OTHER

Soluble fiber

Diet will include foods rich in soluble fiber.

OTHER

Probiotics

Diet will include foods rich in probiotics.

OTHER

Lactose restriction

Diet will be restricted to 5g lactose/day

OTHER

Fiber restriction

Diet will be restricted to 20g fiber/day

OTHER

Fat restriction

Diet will be restricted to 20% total energy intake

Sponsors & Collaborators

• National Institute of Cancerología

  lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-16

Primary Completion

2023-04-28

Completion

2024-03-30

Countries

• Mexico

Study Locations