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

Primary Purpose

Cervical Cancer, Uterine Cervical Neoplasm, Pelvic Inflammatory Disease

Status
Active
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Omega-3 fatty acids
Antioxidants
Soluble fiber
Probiotics
Lactose restriction
Fiber restriction
Fat restriction
Sponsored by
National Institute of Cancerología
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Cancer focused on measuring Cancer, Intestinal inflammation, Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to understand the study and provide informed consent.
  • ECOG: 0-2.
  • Willingness to assist to every programed visit, to keep to the dietary intervention and lab tests.
  • Diagnosed with cervical cancer.
  • Clinical stages IB-2-IVA.
  • Candidate to receive concomitant chemo-radiotherapy followed by brachytherapy.
  • Disease measured by CT scan.
  • No previous treatment based on chemo-radiotherapy. Hemoglobina levels >10g/dL.
  • Leucocytes >4000/mm3.
  • Platelets > 100000/mm3.
  • Adequate hepatic function.

Exclusion Criteria:

  • Patients under nutritional treatment or supplement.
  • Patients with active uncontrolled infections.
  • Patients under treatment with an experimental drug.
  • Patients with fistula at the moment of diagnosis.
  • Patients with previous malignancy.

Sites / Locations

  • Instituto Nacional de Cancerologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anti-inflammatory Diet

Low residue Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in body mass index
weight/height squared
Change in levels of IFN-g [pg/ml]
Determination of serum IFN-g using immune assay ELISA
Change in levels of calprotectin [pg/ml]
Measurement of fecal calprotectin using immune assay ELISA

Secondary Outcome Measures

Change in Gastrointestinal toxicity symptoms grading (severity) scale using the Common Toxicity Criteria for Adverse Events (CTCAE v4)
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)
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.

Full Information

First Posted
October 18, 2018
Last Updated
September 18, 2023
Sponsor
National Institute of Cancerología
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1. Study Identification

Unique Protocol Identification Number
NCT03994055
Brief Title
Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cancerología

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Cervical Neoplasm, Pelvic Inflammatory Disease, Radiation Toxicity, Diet Modification
Keywords
Cancer, Intestinal inflammation, Diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-inflammatory Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Low residue Diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
Diet will include foods rich in omega-3 fatty acids.
Intervention Type
Other
Intervention Name(s)
Antioxidants
Intervention Description
Diet will include foods rich in antioxidant vitamins, trace elements, and polyphenols.
Intervention Type
Other
Intervention Name(s)
Soluble fiber
Intervention Description
Diet will include foods rich in soluble fiber.
Intervention Type
Other
Intervention Name(s)
Probiotics
Intervention Description
Diet will include foods rich in probiotics.
Intervention Type
Other
Intervention Name(s)
Lactose restriction
Intervention Description
Diet will be restricted to 5g lactose/day
Intervention Type
Other
Intervention Name(s)
Fiber restriction
Intervention Description
Diet will be restricted to 20g fiber/day
Intervention Type
Other
Intervention Name(s)
Fat restriction
Intervention Description
Diet will be restricted to 20% total energy intake
Primary Outcome Measure Information:
Title
Change in body mass index
Description
weight/height squared
Time Frame
Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, 6 months after treatment initiation
Title
Change in levels of IFN-g [pg/ml]
Description
Determination of serum IFN-g using immune assay ELISA
Time Frame
Baseline, 3 weeks after treatment initiation, 6 months after treatment initiation
Title
Change in levels of calprotectin [pg/ml]
Description
Measurement of fecal calprotectin using immune assay ELISA
Time Frame
Baseline, 3 weeks after treatment initiation, 6 months after treatment initiation
Secondary Outcome Measure Information:
Title
Change in Gastrointestinal toxicity symptoms grading (severity) scale using the Common Toxicity Criteria for Adverse Events (CTCAE v4)
Description
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.
Time Frame
Baseline, 3 weeks, 12 weeks, 6 months
Title
Change in quality of life summary score using the the quality of life questionnaire specifically developed for cancer patients (EORTC QLQ-C30 v3)
Description
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.
Time Frame
Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, and 6 months after treatment initiation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand the study and provide informed consent. ECOG: 0-2. Willingness to assist to every programed visit, to keep to the dietary intervention and lab tests. Diagnosed with cervical cancer. Clinical stages IB-2-IVA. Candidate to receive concomitant chemo-radiotherapy followed by brachytherapy. Disease measured by CT scan. No previous treatment based on chemo-radiotherapy. Hemoglobina levels >10g/dL. Leucocytes >4000/mm3. Platelets > 100000/mm3. Adequate hepatic function. Exclusion Criteria: Patients under nutritional treatment or supplement. Patients with active uncontrolled infections. Patients under treatment with an experimental drug. Patients with fistula at the moment of diagnosis. Patients with previous malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucely Cetina, MD, MSc
Organizational Affiliation
National Institute of Cancerología
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Nacional de Cancerologia
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25220842
Citation
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Results Reference
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PubMed Identifier
18714169
Citation
Shin DW, Nam JH, Kwon YC, Park SY, Bae DS, Park CT, Cho CH, Lee JM, Park SM, Yun YH. Comorbidity in disease-free survivors of cervical cancer compared with the general female population. Oncology. 2008;74(3-4):207-15. doi: 10.1159/000151368. Epub 2008 Aug 20.
Results Reference
background
PubMed Identifier
11844818
Citation
Pearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D. Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol. 2002 Feb 15;20(4):966-72. doi: 10.1200/JCO.2002.20.4.966.
Results Reference
background
PubMed Identifier
22858731
Citation
Fuccio L, Guido A, Andreyev HJ. Management of intestinal complications in patients with pelvic radiation disease. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1326-1334.e4. doi: 10.1016/j.cgh.2012.07.017. Epub 2012 Jul 31.
Results Reference
background
PubMed Identifier
26649150
Citation
Morris KA, Haboubi NY. Pelvic radiation therapy: Between delight and disaster. World J Gastrointest Surg. 2015 Nov 27;7(11):279-88. doi: 10.4240/wjgs.v7.i11.279.
Results Reference
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PubMed Identifier
24982906
Citation
DeWitt T, Hegazi R. Nutrition in pelvic radiation disease and inflammatory bowel disease: similarities and differences. Biomed Res Int. 2014;2014:716579. doi: 10.1155/2014/716579. Epub 2014 May 28.
Results Reference
background
PubMed Identifier
23611411
Citation
Wedlake LJ, Shaw C, Whelan K, Andreyev HJ. Systematic review: the efficacy of nutritional interventions to counteract acute gastrointestinal toxicity during therapeutic pelvic radiotherapy. Aliment Pharmacol Ther. 2013 Jun;37(11):1046-56. doi: 10.1111/apt.12316. Epub 2013 Apr 23.
Results Reference
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PubMed Identifier
29943770
Citation
Cetina-Perez L, Castro-Eguiluz D, Onate-Ocana LF. Nutrition in Patients with Cancer Treated with Chemo-radiotherapy to the Abdominopelvic Area. A consensus report. Rev Invest Clin. 2018;70(3):109-111. doi: 10.24875/RIC.18002521. No abstract available.
Results Reference
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Citation
Castro-Eguiluz D, Leyva-Islas JA, Luvian-Morales J, Martinez-Roque V, Sanchez-Lopez M, Trejo-Duran G, Jimenez-Lima R, Leyva-Rendon FJ. Nutrient Recommendations for Cancer Patients Treated with Pelvic Radiotherapy, with or without Comorbidities. Rev Invest Clin. 2018;70(3):130-135. doi: 10.24875/RIC.18002526.
Results Reference
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Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer

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