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IRCT20260515069409N1 IRCT 2026-08-12 Shahid Beheshti University of Medical Sciences Investigating the effect of a Low-FODMAP diet in cancer patients undergoing radiotherapy Effect of a Low-FODMAPs Diet (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) on Gastrointestinal Symptoms , Quality of Life and performance status in Cancer Patients Receiving Abdominal and pelvic Radiotherapy: An Interventional Study 2026-08-01 anticipated 40 Recruiting https://irct.ir/trial/90196 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization Procedure In this study, after assessing the eligibility criteria and obtaining written informed consent, participants will be randomly allocated into two groups: the intervention group (receiving the Low-FODMAP diet) and the control group (usual diet). 1. Type and method of randomization: This study will use simple randomization with a 1:1 allocation ratio. A random number table will be used to generate the random allocation sequence. 2. Unit of randomization: The unit of randomization is the individual participant (patient). Each eligible participant, after enrollment and assignment of an identification code, will be allocated to one of the two study groups. 3. Tool and method for generation of the random sequence: The random allocation sequence will be generated by a person who is not involved in participant recruitment or eligibility assessment, using a random number table. For each participant number, group assignment will be determined based on the selected random number (e.g., odd/even numbers corresponding to one of the two groups). The final randomization sequence will be prepared and documented before the start of the study. 4. Allocation concealment: To prevent selection bias, the random allocation sequence will be placed in sequentially numbered, opaque, sealed, and non-transparent envelopes. At the time of enrollment, the researcher will open only the next envelope in sequence, and the participant will be assigned to the corresponding group according to the card inside the envelope. Therefore, the researcher will remain unaware of the group assignment until the envelope is opened. 5. Stratified randomization: Stratified randomization will not be used in this study, and all participants will undergo simple randomization without stratification. N/A Abdominopelvic cancers, radiotherapy, and a low-FODMAP diet.. Intervention 1: Intervention group: Low-FODMAPs Diet (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols). Intervention 2: Control group: Control group: a regular diet for weight maintenance. 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 "There is no further information"
public Dr. Ehsan Hejazi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 info@nnftri.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Ehsan Hejazi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 info@nnftri.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to cooperate and ability to complete the study procedures. Histopathologically confirmed diagnosis of cancer. Candidate for radical or adjuvant radiotherapy. Adequate renal, hepatic, and bone marrow function. Aged between 18 and 75 years. 18 years 75 years Both Unwillingness to cooperate. History of prior radiotherapy. Presence of severe active disease, including IBS. Patients with distant metastatic cancer. C64-C68 Malignant neoplasms of urinary tract Treatment - Other Treatment - Other Intervention group: Low-FODMAPs Diet (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) Control group: Control group: a regular diet for weight maintenance. Quality of Life (QoL) score. Timepoint: Before the start of radiotherapy, one week after initiation, at the end of the third week, and at the end of the radiotherapy course (weeks 5–7). Method of measurement: Quality of Life (QoL) score. Gastrointestinal Symptoms. Timepoint: Before the start of radiotherapy, one week after initiation, at the end of the third week, and at the end of the radiotherapy course (weeks 5–7). Method of measurement: Toxicity criteria of the Radiation Therapy Oncology Group (RTOG), PRSS score. Performance status. Timepoint: Before the start of radiotherapy, one week after initiation, at the end of the third week, and at the end of the radiotherapy course (weeks 5–7). Method of measurement: Performance status assessment in cancer patients. Shahid Beheshti University of Medical Sciences Approved 2025-12-16 Research Ethics Committee of Shahid Beheshti University of Medical Sciences No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town, tehran Tehran Iran (Islamic Republic of)