NCT03994055Completed
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 · Last updated 25 May 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 18 Oct 2018
- Start date
- 16 Nov 2018
- Primary completion date
- 28 Apr 2023
- Lead sponsor
- National Institute of Cancerología
- Diseases
- Cervical cancer
- NCT number
- NCT03994055
What you commit to
- Study type: Interventional
- Participants enrolled: 136
- From 16 Nov 2018 to the primary completion date, 28 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients under treatment with an experimental drug.
Other illness
- Patients with active uncontrolled infections.
- Patients with fistula at the moment of diagnosis.
- Patients with previous malignancy.
Other
- Patients under nutritional treatment or supplement.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Cancerologia Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.