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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT03100409
• Date of registration: 24/03/2017
• Prospective Registration: No
• Primary sponsor: National Institute of Cancerología
• Public title: Effect of a Low Residue Diet in Comparison to the Dietetic Recommendations From the INCan in Cervical Cancer Patients
• Scientific 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)
• Date of first enrolment: February 1, 2017
• Target sample size: 137
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03100409
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Lucely C Cetina, MD, MSc
• Affiliation: National Institute of Cancerología

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Gastrointestinal Complication

Radiation Toxicity

Uterine Cervical Neoplasm

Dietary Modification

Intervention(s)

Other: Dietary modification

Primary Outcome(s)

Change in Gastrointestinal toxicity symptoms grading scale using the Common Toxicity Criteria for Adverse Events (CTCAE v4) [Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .]

Changes in nutritional status [Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .]

Changes in food intake [Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .]

Secondary Outcome(s)

Changes in body weight [Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .]

Changes in body composition (phase angle) [Time Frame: 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) [Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .]

Changes in handgrip strength measures [Time Frame: 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)) [Time Frame: Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation .]

Secondary ID(s)

CEI/1125/17

INCAN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran