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

NCT03994055 | Completed

• 1 other identifier: CEI/1247/17
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cancer; Intestinal inflammation; Diet

Outcome Measures

Primary Outcomes (3)

• Change in body mass index

  weight/height squared

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, 6 months after treatment initiation

• Change in levels of IFN-g [pg/ml]

  Determination of serum IFN-g using immune assay ELISA

  Baseline, 3 weeks after treatment initiation, 6 months after treatment initiation

• Change in levels of calprotectin [pg/ml]

  Measurement of fecal calprotectin using immune assay ELISA

  Baseline, 3 weeks after treatment initiation, 6 months after treatment initiation

Secondary Outcomes (2)

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

  Baseline, 3 weeks, 12 weeks, 6 months

• Change in quality of life summary score using the the quality of life questionnaire specifically developed for cancer patients (EORTC QLQ-C30 v3)

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, and 6 months after treatment initiation

Study Arms (2)

Anti-inflammatory Diet

EXPERIMENTAL

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; Other: Antioxidants; Other: Soluble fiber; Other: Probiotics

Low residue Diet

ACTIVE COMPARATOR

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; Other: Fiber restriction; Other: Fat restriction

Interventions

Omega-3 fatty acids OTHER

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

Anti-inflammatory Diet

Antioxidants OTHER

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

Anti-inflammatory Diet

Soluble fiber OTHER

Diet will include foods rich in soluble fiber.

Anti-inflammatory Diet

Probiotics OTHER

Diet will include foods rich in probiotics.

Anti-inflammatory Diet

Lactose restriction OTHER

Diet will be restricted to 5g lactose/day

Low residue Diet

Fiber restriction OTHER

Diet will be restricted to 20g fiber/day

Low residue Diet

Fat restriction OTHER

Diet will be restricted to 20% total energy intake

Low residue Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (9)

• 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.

  PMID: 25220842 BACKGROUND

• 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.

  PMID: 18714169 BACKGROUND

• 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.

  PMID: 11844818 BACKGROUND

• 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.

  PMID: 22858731 BACKGROUND

• 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.

  PMID: 26649150 BACKGROUND

• 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.

  PMID: 24982906 BACKGROUND

• 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.

  PMID: 23611411 BACKGROUND

• 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.

  PMID: 29943770 BACKGROUND

• 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.

  PMID: 29943773 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pelvic Inflammatory Disease; Radiation Injuries; Neoplasms

Interventions

Fatty Acids, Omega-3; Antioxidants; Probiotics

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Infection; Infections; Adnexal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lucely Cetina, MD, MSc

  National Institute of Cancerología

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: June 21, 2019
• Study Start: November 16, 2018
• Primary Completion: April 28, 2023
• Study Completion: March 30, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)