Clinical trial · Interventional
Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer
Effect of an Anti-inflammatory Diet on the Nutritional Status and Cytokine Expression of Patients With Locally Advanced Cervical Cancer: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Diet Modification | — | UNRESOLVED | — |
| Pelvic Inflammatory Disease | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Uterine Cervical Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antioxidants | Other | — | UNRESOLVED |
| Fat restriction | Other | — | UNRESOLVED |
| Fiber restriction | Other | — | UNRESOLVED |
| Lactose restriction | Other | — | UNRESOLVED |
| Omega-3 fatty acids | Other | — | UNRESOLVED |
| Probiotics | Other | — | UNRESOLVED |
| Soluble fiber | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anti-inflammatory Diet
- 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.
- interventionNames
- Other: Omega-3 fatty acids
- Other: Antioxidants
- Other: Soluble fiber
- Other: Probiotics
- type
- ACTIVE_COMPARATOR
- label
- Low residue Diet
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDFerlay 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
- BACKGROUNDShin 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
- BACKGROUNDPearcey 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
- BACKGROUNDFuccio 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
- BACKGROUNDMorris 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
- BACKGROUNDDeWitt 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
- BACKGROUNDWedlake 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.