Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT03994055|
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Uterine Cervical Neoplasm Pelvic Inflammatory Disease Radiation Toxicity Diet Modification||Other: Omega-3 fatty acids Other: Antioxidants Other: Soluble fiber Other: Probiotics Other: Lactose restriction Other: Fiber restriction Other: Fat restriction||Not Applicable|
Cervical cancer is the second most frequent cancer in Mexican women, representing 16.9% of the total female population. At the National Cancer Institute of Mexico (Instituto Nacional de Cancerología), 80% cervical cancer patients arrive at locally advanced stages (IB2-IVA). Standard treatment for these stages is based on concomitant chemo-radiotherapy. 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. Acute PRD occurs during the time of treatment in 60 to 80% patients, symptoms include nausea, diarrhea, tenesmus, abdominal pain, urgency, mucositis, anorexia, bleeding and fatigue; these symptoms limit cancer treatment and affect the patients' quality of life. Chronic PRD is a progressive condition and a problem for cervical cancer survivors, symptoms include altered intestinal traffic, altered intestinal motility and nutrient malabsorption. The intestinal immune system plays an important role in the development of PRD and the secondary effects of RT. 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. Among some of the nutritional intervention assays for patients with PRD, some have described that a low residue diet, restricted in fat (20-25%), lactose (5g) and fiber (20g), reduces the frequency and severity of diarrhea; however, this dietary intervention does not prevent weight loss or malnutrition in patients. Furthermore, low residue diets limit the beneficial effect of dietary fiber and fatty acids that may aid in the inflammatory response. Likewise, patients with inflammatory bowel disease (IBD) develop similar symptoms to PRD. Studies developed in these patients 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 individualized energy requirements and nutrient proportions for patients without comorbidities, and for patients with comorbidities such as obesity, type 2 diabetes, hypertension and renal dysfunction, will be calculated according to the recommendations derived from the Consensus of Nutrition in patients with cancer treated with chemo-radiotherapy to the abdominopelvic area. Furthermore, the nutritional intervention will include food rich in immune-modulating nutrients: omega-3 fatty acids, soluble fiber, antioxidants and polyphenols, and probiotics. Because the low residue diet is routinely used for patients that receive pelvic radiation in other institutions, the anti-inflammatory nutritional intervention will be compared with the low residue diet.
An open controlled randomized clinical trial will be performed on women with locally advanced cervical cancer. Candidates will be randomly assigned to one of the two dietary interventions. Experimental group will receive an anti-inflammatory diet with an energy intake of 28-31 kcal/kg/day, based on 30-40% fat, 20% protein, and 40-50% carbohydrates, the diet will include foods rich in omega-3 fatty acids, soluble fiber, antioxidants and polyphenols, and probiotics. The control group will receive a low residue diet with 28-91 kcal/kg/day, based on 20% fat, 20% protein, and 60% carbohydrates, with no more than 20g fiber and 5g of lactose. In both groups, before, during and after cancer treatment, a thorough nutritional evaluation will be performed, gastrointestinal toxicity will be assessed, and serum cytokine levels and fecal calprotectin and lactoferrin levels will be determined to establish the local and systemic inflammatory response. The quality of life of patients will also be assessed before and after treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of an Anti-inflammatory Diet on the Nutritional Status and Cytokine Expression of Patients With Locally Advanced Cervical Cancer: A Randomized Clinical Trial|
|Actual Study Start Date :||November 16, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
Experimental: Anti-inflammatory Diet
Dietary intervention providing:
Energy: 28-31 kcal/kg/day. Protein: 20-30%. Fat: 30-40%. Carbohydrates: 40-50%. The diet will be individualized according to the patients' comorbidities (obesity, type 2 diabetes, hypertension, renal insufficiency).
This group will include the consumption of foods that contain immune modulating nutrients:
Omega-3 fatty acids, antioxidants, soluble fiber, probiotics. The recommendation to include these foods will be made according to the patients' access to food in their home area.
Other: Omega-3 fatty acids
Diet will include foods rich in omega-3 fatty acids.
Diet will include foods rich in antioxidant vitamins, trace elements, and polyphenols.
Other: Soluble fiber
Diet will include foods rich in soluble fiber.
Diet will include foods rich in probiotics.
Active Comparator: Low residue Diet
Dietary intervention providing:
Energy: 28-31 kcal/kg/day. Protein: 20%. Fat: 20%. Carbohydrates: 60%. Diet will have lactose restriction, fiber restriction and fat restriction.
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
- Change in body mass index [ Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, 6 months after treatment initiation ]weight/height squared
- Change in levels of IFN-g [pg/ml] [ Time Frame: Baseline, 3 weeks after treatment initiation, 6 months after treatment initiation ]Determination of serum IFN-g using immune assay ELISA
- Change in levels of calprotectin [pg/ml] [ Time Frame: Baseline, 3 weeks after treatment initiation, 6 months after treatment initiation ]Measurement of fecal calprotectin using immune assay ELISA
- Change in Gastrointestinal toxicity symptoms grading (severity) scale using the Common Toxicity Criteria for Adverse Events (CTCAE v4) [ Time Frame: Baseline, 3 weeks, 12 weeks, 6 months ]
Evaluation of the severity of gastrointestinal symptoms according to the Common Toxicity Criteria for Adverse Events (CTCAE v4).
A grading (severity) scale is provided for each adverse event (AE) term. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 Life-threatening consequences; urgent intervention indicated.
Grade 5 Death related to AE.
- Change in quality of life summary score using the the quality of life questionnaire specifically developed for cancer patients (EORTC QLQ-C30 v3) [ Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, and 6 months after treatment initiation ]Quality of life questionnaire developed and validated for cancer patients (EORTC QLQ-C30 v3, in spanish) will be applied, and the change in summary score will be evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994055
|Contact: Angel D Castro, PhDfirstname.lastname@example.org|
|Contact: Julissa Luvian, MScemail@example.com|
|Instituto Nacional de Cancerologia||Recruiting|
|Mexico City, Distrito Federal, Mexico, 14080|
|Contact: David Cantu, MD, PhD 56280400 ext 37015 firstname.lastname@example.org|
|Contact: Lucely Cetina, MD, MSc 56280400 ext 12220 email@example.com|
|Principal Investigator: Lucely Cetina, MD|
|Study Chair:||Lucely Cetina, MD, MSc||National Institute of Cancerología|