Cervical CancerNCT03994055
Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer
A study testing Omega-3 fatty acids, Antioxidants and Soluble fiber in people with Cervical Cancer and Uterine Cervical Neoplasm, run by National Institute of Cancerología at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cervical Neoplasm, Pelvic Inflammatory Disease
- What is being tested?
- Omega-3 fatty acids, Antioxidants and Soluble fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteMexico
- Study dates
- 16 Nov 2018to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14080
About this study
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
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.
Read the 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.
- Conditions
- Cervical Cancer, Uterine Cervical Neoplasm, Pelvic Inflammatory Disease, Radiation Toxicity, Diet Modification
- Being tested
- Omega-3 fatty acids, Antioxidants, Soluble fiber, Probiotics, Lactose restriction
- Keywords
- Cancer, Intestinal inflammation, Diet
- Medical subject headings
- Uterine Cervical Neoplasms, Pelvic Inflammatory Disease, Radiation Injuries, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsOther
Diet will include foods rich in omega-3 fatty acids.
AntioxidantsOther
Diet will include foods rich in antioxidant vitamins, trace elements, and polyphenols.
Soluble fiberOther
Diet will include foods rich in soluble fiber.
ProbioticsOther
Diet will include foods rich in probiotics.
Lactose restrictionOther
Diet will be restricted to 5g lactose/day
Fiber restrictionOther
Diet will be restricted to 20g fiber/day
Fat restrictionOther
Diet will be restricted to 20% total energy intake
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Lactose restriction; Other: Fiber restriction; Other: Fat restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index
weight/height squared
Measured: 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
Measured: 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
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, and 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start16 Nov 2018
- Primary completion28 Apr 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lucely Cetina, MD, MSc, Study chair, National Institute of Cancerología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994055
- Sponsor's protocol ID
- CEI/1247/17
- Status last verified
- May 2025
- First submitted
- 18 Oct 2018
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25220842Shin 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.
PubMed 18714169Pearcey 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.
PubMed 11844818Fuccio 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.
PubMed 22858731Morris 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.
PubMed 26649150DeWitt 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.
PubMed 24982906Wedlake 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.
PubMed 23611411Cetina-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.
PubMed 29943770Castro-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.
PubMed 29943773Luvian-Morales J, Rueda-Escalona AA, Delgadillo-Gonzalez M, Cetina-Perez LDC, Villalpando-Sanchez DC, Gomez-Jimenez AM, Rodriguez-Moreno MI, Medina-Contreras O, Castro-Eguiluz D. Benefits of an anti-inflammatory diet compared to a low-residue diet during concurrent chemoradiation therapy for patients with locally advanced cervical cancer: a randomized clinical trial. Front Nutr. 2026 Jul 13;13:1835417. doi: 10.3389/fnut.2026.1835417. eCollection 2026.
PubMed 42516234
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03994055
- Acronym / sponsor ID
- CEI/1247/17
- Conditions
- Cervical Cancer, Uterine Cervical Neoplasm, Pelvic Inflammatory Disease, Radiation Toxicity, Diet Modification
- Keywords
- Cancer, Intestinal inflammation, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory Diet | Experimental | Other: Omega-3 fatty acids, Other: Antioxidants, Other: Soluble fiber, Other: ProbioticsDietary 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. |
| Low residue Diet | Active comparator | Other: Lactose restriction, Other: Fiber restriction, Other: Fat restrictionDietary intervention providing: Energy: 28-31 kcal/kg/day. Protein: 20%. Fat: 20%. Carbohydrates: 60%. Diet will have lactose restriction, fiber restriction and fat restriction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acidsDiet will include foods rich in omega-3 fatty acids. | Other | Anti-inflammatory Diet |
| AntioxidantsDiet will include foods rich in antioxidant vitamins, trace elements, and polyphenols. | Other | Anti-inflammatory Diet |
| Soluble fiberDiet will include foods rich in soluble fiber. | Other | Anti-inflammatory Diet |
| ProbioticsDiet will include foods rich in probiotics. | Other | Anti-inflammatory Diet |
| Lactose restrictionDiet will be restricted to 5g lactose/day | Other | Low residue Diet |
| Fiber restrictionDiet will be restricted to 20g fiber/day | Other | Low residue Diet |
| Fat restrictionDiet will be restricted to 20% total energy intake | Other | Low residue Diet |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 18714169Shin 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.
- Background: PubMed 11844818Pearcey 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.
- Background: PubMed 22858731Fuccio 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.
- Background: PubMed 26649150Morris 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.
- Background: PubMed 24982906DeWitt 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.
- Background: PubMed 23611411Wedlake 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.
- Background: PubMed 29943770Cetina-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.
- Background: PubMed 29943773Castro-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.
- Derived from this study: PubMed 42516234Luvian-Morales J, Rueda-Escalona AA, Delgadillo-Gonzalez M, Cetina-Perez LDC, Villalpando-Sanchez DC, Gomez-Jimenez AM, Rodriguez-Moreno MI, Medina-Contreras O, Castro-Eguiluz D. Benefits of an anti-inflammatory diet compared to a low-residue diet during concurrent chemoradiation therapy for patients with locally advanced cervical cancer: a randomized clinical trial. Front Nutr. 2026 Jul 13;13:1835417. doi: 10.3389/fnut.2026.1835417. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucely Cetina, MD, MSc study chair
National Institute of Cancerología
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids, Antioxidants and Soluble fiber in people with Cervical Cancer and Uterine Cervical Neoplasm, run by National Institute of Cancerología at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (time frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, 6 months after treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03994055, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.