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

NCT03100409 | Terminated

• 2 other identifiers: CEI/1125/17INCAN
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasm; Dietary Modification; Radiation Toxicity; Gastrointestinal Complication

Keywords

Cervical cancer

Outcome Measures

Primary Outcomes (3)

• Change in Gastrointestinal toxicity symptoms grading scale using the Common Toxicity Criteria for Adverse Events (CTCAE v4)

  Evaluation of the gastrointestinal symptoms according to the Common Toxicity Criteria for Adverse Events (CTCAE v4). A grading 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 after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

• Changes in nutritional status

  Evaluation the change of the nutritional status by the Patient Generated Subjective Global Assessment. The Patient Generated Subjective Global Assessment is a questionnaire that comprises 7 sections: weight, intake, symptoms, functional capacity, disease and its relationship to nutritional requirements, metabolic demand and physical evaluation. Based on the previous results the interviewer will define which of the following three groups the individual surveyed belongs to: A: well nourished. B: moderately or suspiciously undernourished. C: severely malnourished.

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

• Changes in food intake

  Change in food intake assessed by 24-hour reminder This method consists of questioning the subject to find out everything he or she ingested the day before. It includes three lists of foods to help the interviewee remember, the first is a quick list that contains drinks and foods, the second list contains foods that are commonly forgotten and the interview closes with a detailed description of everything that was consumed

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

Secondary Outcomes (5)

• Changes in body weight

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

• Changes in body composition (phase angle)

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

• Changes in handgrip strength measures

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

• Change in quality of life summary score using the the quality of life questionnaire specifically developed for cancer patients (European Organization for Research and Treatment of Cancer Core 30 (EORTC QLQ-C30 v3))

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

• Change in quality of life for cervical cancer patients: (European Organization for Research and Treatment of Cancer Cervical cancer module- EORTC QLQ-CX 24)

  Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .

Study Arms (2)

Dietary modification

EXPERIMENTAL

Personalized dietary intervention, low residue diet

Other: Dietary modification

Control

NO INTERVENTION

Dietary recommendations currently used in the INCan

Interventions

Dietary modification OTHER

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.

Dietary modification

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cancerología: lead
• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: collaborator

Study Sites (1)

National Cancer Institute of Mexico

Mexico City, Tlalpan, 14080, Mexico

Location

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MeSH Terms

Conditions

Uterine Cervical Neoplasms; Radiation Injuries

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Lucely C Cetina, MD, MSc

  National Institute of Cancerología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc.

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 4, 2017
• Study Start: February 1, 2017
• Primary Completion: November 30, 2020
• Study Completion: September 1, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)