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IRCT20240406061430N1 IRCT 2024-05-05 Shahed University A Multiple Intervention on Adult Patients The Effect of a Multimodal Interventions on the Quality of Life, Physical Performance and Body Composition of Adult Patients with Cachexia Caused by Gastric and Esophageal Cancer: a Clinical Trial 2024-05-21 anticipated 40 Complete https://irct.ir/trial/76337 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: It will Be Done by Simple Random Sampling and Through Lottery, in which a Number or Code is Prepared for Each Member of the Community, then the Numbers are Written on Pieces of Paper. The Pieces of Paper are Placed in a Container and Mixed well, then a Sample of a Certain Volume is Selected from It. N/A Cachexia caused by gastric and esophagus cancer. Intervention 1: In addition to their usual treatment, they will receive resistance training with exercise bands, a Mediterranean diet, a prescription for 150 minutes of low-to-moderate aerobic exercise, and exercise adherence tips to change behavior toward an active lifestyle. Intervention 2: Control group: They do not receive any intervention other than their usual treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not knowing the University regulations regarding it
public Fateme Faraji Sefidkhani
No. 200, Som East Alley, Qiamadasht, Valiasr St., 4th Floor, Unit 10
Tehran Iran (Islamic Republic of) 1867174765 +98 21 3358 7143 faraji4156@gmail.com Shahed University scientific Amin Isanezhad
Shahed University, opposite to the Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 2442 A.isanezhad@shahed.ac.ir Shahed University Iran (Islamic Republic of) 1. Patients with Gastric and Esophageal Cancer 2. Patients with Cachexia 3. Successful Eligibility for First-Line Radiotherapy or Chemotherapy Guidelines 4. Patients' Treatment Process must be Complete 5. Karnofsky Functional Status at least 70% 6. Nutritional Drugs 7. Patients without Uncontrolled Acute Underlying Diseases, Kidney Failure, Disease, Acquired Immunodeficiency Syndrome, Intestinal Diseases or Chronic Disease Treatments that Cause Cachexia Related to the Disease 8. Male and Female Patients 18 years and Older 9. Willing Patients To Participate in the Study 10. Having a Doctor's Permission to Participate in Diet and Exercise 11.Having Online Classes. 18 years no limit Both 1. Patients Who Die 2. Patients Who Comply with Less than 60% of the Recommended Nutrition 3. Changing the Route of Oral Nutrition to Enteral or Intravenous Nutrition 4. Reluctance to Continue the Study 5. Changing the Treatment Protocol 6. Major Surgery in the Last 4 Weeks . Rehabilitation Rehabilitation In addition to their usual treatment, they will receive resistance training with exercise bands, a Mediterranean diet, a prescription for 150 minutes of low-to-moderate aerobic exercise, and exercise adherence tips to change behavior toward an active lifestyle. Control group: They do not receive any intervention other than their usual treatment Mediterranean Diet. Timepoint: Before and After. Method of measurement: PG-SGA Nutritional Status Questionnaire. Quality of Life. Timepoint: Before and After. Method of measurement: EOPTC-QLQ-C30 Quality of Life Questionnaire. Tiredness. Timepoint: Before and After. Method of measurement: FSS Fatigue Intensity Questionnaire. Physical Performance. Timepoint: Before and After. Method of measurement: Getting up and Sitting for 30 Seconds. Upper Limb Muscle Strength. Timepoint: Before and After. Method of measurement: 5 Repetition Maximum Chest Press Test. Lower Limb Muscle Strength. Timepoint: Before and After. Method of measurement: 5 Repetition Maximum Leg Press Test. Body Fat Percentage. Timepoint: Before and After. Method of measurement: Abdominal CT Scan Without Contrast. Visceral Fat. Timepoint: Before and After. Method of measurement: Abdominal CT Scan Without Contrast. Muscle Mass. Timepoint: Before and After. Method of measurement: Abdominal CT Scan Without Contrast. Mediterranean Diet. Timepoint: Before and After. Method of measurement: FFQ Food Frequency Questionnaire. Mediterranean Diet. Timepoint: The Second, Fourth, Sixth and Eighth Week of Study. Method of measurement: 24-Hour Food Reminder Questionnaire. Quality of Life. Timepoint: Before and After. Method of measurement: Sharkey Physical Activity Questionnaire. Shahed University Approved 2024-03-09 Ethics Committee of Shahid University Shahed university, opposite to the Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)