Radiation Toxicity Clinical Trial
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)
Verified date | September 2021 |
Source | National Institute of Cancerología |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 137 |
Est. completion date | September 1, 2021 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | National Cancer Institute of Mexico | Mexico City | Tlalpan |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cancerología | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
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* Note: There are 56 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 . | |
Primary | 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 . | |
Primary | 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 | Changes in body weight | Evaluation the changes of the body weight (kilograms) The measurement will be done on a hospital scale SECA brand. | Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation . | |
Secondary | Changes in body composition (phase angle) | Evaluation the changes of the phase angle (grades) by the bioelectrical impedance Biolelectrical impedances will be evaluated by body composition analyzer Quantun IV The phase angle is a nutritional indicator which evaluates the distribution of intracellular and extracellular fluid, therefore, it has been described as an indicator of the quality of the cell membrane | Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation . | |
Secondary | Changes in handgrip strength measures | Evaluation the change of the handgrip strength (kilograms)
Handgript strength will be evaluated by a dinamometer Takei Hand strength is a simple measure, it has been used to estimate total muscle strength and has been described as a marker of nutritional status, in addition, it is related to mortality and morbidity (56). The instrument for measuring hand force is the dynamometer, and the cut-off points for making a diagnosis of sarcopenia in women is a result ?de 20 kg, while in men it is ?de 30 kg |
Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation . | |
Secondary | 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)) | Quality of life questionnaire developed and validated for cancer patients ((European Organization for Research and Treatment of Cancer Core 30 (EORTC QLQ-C30 v3)) will be applied, and the change in summary score will be evaluated.
The EORTC QLQ-C30 questionnaire evaluates the quality of life in oncological population, is composed of both multi-item and single-item measures. It has 30 items, including nine scales: five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, pain and nausea / vomiting) and one global health status/QoL scale. Six single items are also included (Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea and Financial difficulties). A high score for all functional and global health/QoL scales represents a high/healthy level of functioning/high QoL, whereas a high score for a symptom scale/item represents a high level of symptoms/problems. |
Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation . | |
Secondary | Change in quality of life for cervical cancer patients: (European Organization for Research and Treatment of Cancer Cervical cancer module- EORTC QLQ-CX 24) | Change in quality of life summary score and subescales using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module (EORTC QLQ-CX24). The EORTC QLQ-CX24 is the supplementary module of the QLQ-C30 aimed to evaluate quality of life of cervical cancer patients.
The EORTC QLQ-CX24 is the supplementary module of the QLQ-C30 aimed to evaluate quality of life of cervical cancer patients. It consists of 24 items divided in three multi-item scales to assess symptoms experience (gastrointestinal and genitourinary), body image and sexual/vaginal functioning, and six single items to assess lymphedema, peripheral neuropathy, menopausal symptoms, sexual worry, sexual activity and sexual enjoyment. The last five questions are answered only by patients with an active sex life. Higher scores are equivalent to worse or more symptoms, except for items 49 and 54 (higher score indicates better quality of life). |
Baseline, 3 weeks after treatment initiation, 12 weeks after treatment initiation and 6 months after treatment initiation . |
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