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Effect of a Low Residue Diet in Comparison to the Dietetic Recommendations From the INCan in Cervical Cancer Patients

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ClinicalTrials.gov Identifier: NCT03100409
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Dr. Lucely Cetina Pérez, National Institute of Cancerología

Brief Summary:
In Mexico, cervical cancer (CC) ranks second in incidence and mortality among women. The National Institute of Cancer in Mexico (lNCan) receives annually about 500 patients with CC, 80% of which are diagnosed with locally advanced disease. The standard treatment for locally advanced disease consists in concomitant chemo-radiotherapy based on cisplatin (QT-RT), followed by brachytherapy, with an absolute benefit of 10%. Adverse effects include gastrointestinal toxicity, which is the most important factor limiting the dosage of pelvic radiation. Cancer treatment, in any modality, induces malnutrition, more so when combined treatments are administered. Radiation induced gastrointestinal toxicity is caused by different factors, among which are malabsorption of bile, fat and carbohydrates, decrease in brush border enzymes, diverticular disease, proctitis, and psychological factors. International guidelines for cancer patients recommend nutritional assessment in these patients before they start treatment, so nutritional risk can be detected and the patient may get started on dietary intervention to prevent malnutrition. Several authors have studied the dietary management that may help reduce the gastrointestinal effects in cancer patients receiving pelvic radiotherapy. To reduce diarrhea and prevent malnutrition the recommended dietary approach is a low residue diet consisting on 20-25% kcal from fat, 5g of lactose and 20g of fiber. Currently the INCan does not follow the nutrition care process for cervical cancer patients; written recommendations are given to the patients with a list of foods allowed or not allowed, with no further nutritional assessment or intervention. From previous studies, the investigators have demonstrated that the current recommendations do not help the patients maintain their nutritional status, during their treatment most patients become malnourished (81%, p<0.01). Therefore, the aim of this clinical trial is to evaluate a diet low in residue in CC patients, considering the necessary modifications for each patient if morbidities are present, in comparison with the current dietary recommendations used in the INCan.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasm Dietary Modification Radiation Toxicity Gastrointestinal Complication Other: Dietary modification Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effect of a Low Residue Diet in Comparison to the Dietary Recommendations From the INCan: A Randomized Clinical Trial to Assess Malnutrition, Gastrointestinal Toxicity and Quality of Life of Advanced Cervical Cancer Patients (IB2-IVA)
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Dietary modification
Personalized dietary intervention, low residue diet
Other: Dietary modification

Dietary intervention will consist on a low residue diet: 20% kcal from fat, 5g lactose/day, 20g fiber/day (5g from insoluble fiber).

Dietary intervention will be adapted to the patient's individual requirements, according to the presence of comorbidities or renal deterioration.

  1. No comorbidities. Energy: 20-30 kcal/kg of body weight/day. Protein: 1.3 g/kg of body weight/day.
  2. Comorbidities (diabetes, hypertension), or geriatric patient. Energy: 25-30 kcal/kg of body weight/day. Protein: 1.5 g/kg of body weight/day.
  3. Renal deterioration. Energy: 30-35 kcal/kg of body weight/day. Protein: 1 g/kg of body weight/day. Sodium: 2000-2300 mg/day. Potassium: 1900-2730 mg/day. Phosphorus: 800-1000 mg/day.

No Intervention: Control
Dietary recommendations currently used in the INCan



Primary Outcome Measures :
  1. Efficacy: Nutritional status evaluated by the complete nutritional assessment [ Time Frame: Through treatment completion, at week 21. ]
    Nutritional status will be evaluated by the complete nutritional assessment described above.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18 years of age and older.
  • Ability to understand the study and be able to sign the informed consent.
  • Functional stage ECOG 0 - 2.
  • Negative pregnancy test, null reproductive potential, or currently using an contraceptive method.
  • Willing and able to attend the programmed visits.
  • Diagnosed with cervical malignant tumors of epithelial origin in the neck of the uterus, clinical stages IB2-IVA.
  • Candidates to receive concomitant Chemo-Radiotherapy, followed by Brachytherapy.
  • In case of presence of diabetes mellitus and/or hypertension, without retinopathy or albuminuria <300 mg/dl.
  • In case of renal deterioration, a creatinine clearance >20 ml/min.
  • Hemoglobin >10 g/l.
  • Leucocytes > 4000/mm3.
  • Platelets >100000/mm3.

Exclusion Criteria:

  • Under a different nutritional treatment using a nutritional supplement.
  • Carrying other uncontrolled diseases, including cardiovascular insufficiency, arrhythmia, psychiatric illnesses.
  • Concomitant treatment with another experimental drug.
  • Active TB.
  • Infected with HIV.
  • History of LES and other rheumatologic diseases that involve renal deterioration.
  • Presence of vesicular-vaginal fistulae at moment of diagnosis.
  • Previous malignancy.

Study Discontinuation Criteria:

  • Loss of follow up for 21 days.
  • Evidence of disease progression.
  • At the request of patient.
  • By unacceptable toxicity.
  • Pregnancy.

Criteria must be followed punctually. If a patient were inappropriately included, she must be discontinued from the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100409


Contacts
Contact: Lucely C Cetina, MD,MSc +5215531952791 lucelycetina.incan@gmail.com
Contact: Angel D Castro, RDN, PhD +5215541940650 angeldenisse@gmail.com

Locations
Mexico
National Cancer Institute of Mexico Recruiting
Mexico City, Tlalpan, Mexico, 14080
Contact: LUCELY CETINA, MD,MSc    +5215531952791    lucelycetina.incan@gmail.com   
Contact: Angel D Castro, RDN, PhD    +5215541940650    angeldenisse@gmail.com   
Sponsors and Collaborators
National Institute of Cancerología
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Lucely C Cetina, MD, MSc National Institute of Cancerología

Publications of Results:
Other Publications:

Responsible Party: Dr. Lucely Cetina Pérez, MD, MSc., National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT03100409     History of Changes
Other Study ID Numbers: CEI/1125/17
INCAN ( Other Identifier: Instituto Nacional de Cancerología )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Lucely Cetina Pérez, National Institute of Cancerología:
Cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female