Cervical Cancer Clinical Trial
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
Verified date | September 2023 |
Source | National Institute of Cancerología |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 136 |
Est. completion date | January 2024 |
Est. primary completion date | April 28, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cancerologia | Mexico City | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cancerología |
Mexico,
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. — View 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. — View Citation
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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. — View Citation
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in body mass index | weight/height squared | Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, 6 months after treatment initiation | |
Primary | 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 | |
Primary | 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 | 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. |
Baseline, 3 weeks, 12 weeks, 6 months | |
Secondary | 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. | Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation, and 6 months after treatment initiation |
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