colorectal cancer. Malignant neoplasm of colon
Conditions
Interventions
Intervention 1: Intervention group: Patients in this group will receive Rectocare herbal gel in addition to routine care and the standard radiotherapy protocol. Rectocare Gel is manufactured by Fidar
Sponsors
Sanandaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Definite diagnosis of rectal cancer (Stage II–III) confirmed by an oncologist. Receiving radiotherapy with a specified dose (=45 Gy) at Tohid Radiotherapy Center. Age between 18 and 70 years. Ability to understand and complete the study questionnaires. No use of other similar supportive care methods or herbal gels during the study period. No concurrent use of other similar therapeutic interventions alongside radiotherapy. No history of allergic reactions to any of the components of Rectocare gel.
Exclusion criteria
Exclusion criteria: Any change in the patient’s treatment plan (e.g., discontinuation of radiotherapy). Occurrence of severe, uncontrollable adverse events requiring emergency intervention. Lack of cooperation in completing questionnaires or attending follow-up visits. Development of hypersensitivity or allergic reaction to Rectocare gel. Patients who receive chemotherapy during the course of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome variable: Severity of radiotherapy-induced gastrointestinal complications based on the Common Terminology Criteria for Adverse Events, version 3 (CTCAE v3).This variable will be assessed using CTCAE v3 items related to gastrointestinal complications, including diarrhea, constipation, nausea, vomiting, abdominal pain, rectal bleeding, anal or rectal mucositis, rectal stricture or ulceration, and other radiotherapy-induced gastrointestinal adverse effects. The severity of each complication will be recorded separately using the five-grade CTCAE scale, including mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), and death related to the adverse event (Grade 5). CTCAE v3 is an internationally standardized tool for evaluating cancer treatment-related adverse events. Prior to the main study, the Persian version of the instrument will be validated through forward-backward translation and assessment of face and content validity in accordance with WHO guidelines. Timepoint: The primary outcomes will be measured at multiple predefined time points. Data collection will be conducted at baseline (before randomization and initiation of the intervention), followed by weekly assessments from week 1 to week 7 during the intervention period, and a final assessment at week 9 after completion of the intervention to evaluate the persistence of the intervention effects. Therefore, outcome measurements will be performed at nine time points: baseline (T0), weeks 1–7 of the intervention (T1–T7), and week 9 post-intervention follow-up (T8). This schedule is designed to monitor temporal changes in radiotherapy-induced gastrointestinal complications and patients’ quality of life throughout the intervention period and to assess the sustainability of the intervention effects after its completion. Method of measurement: The severity of radiotherapy-induced gastrointestinal complications will be measured using Version 3 of the instrument Common Termino | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome: Quality of Life in Patients with Colorectal CancerQuality of life in patients with colorectal cancer will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Colorectal Cancer 29 (EORTC QLQ-CR29). This disease-specific questionnaire consists of 29 items and is designed to evaluate quality of life and disease-related symptoms in patients with colorectal cancer. The domains assessed include bowel symptoms, urinary symptoms, sexual symptoms, physical problems, and psychological and emotional aspects associated with the disease. Responses are recorded using a four-point Likert scale ranging from “not at all” to “very much”.Scores for each subscale will be calculated according to the standard scoring manual of the instrument and subsequently transformed linearly to a 0–100 scale. Higher scores on the functional scales indicate better quality of life, whereas higher scores on the symptom scales represent greater symptom severity. Timepoint: Patient quality of life will be assessed at multiple pre-specified time intervals. Data collection will be conducted at baseline (prior to randomization and the initiation of the intervention), followed by weekly evaluations throughout the intervention period from Week 1 to Week 7. A final assessment will be performed at Week 9, post-intervention, to evaluate the sustainability of the treatment effects. Consequently, outcomes will be measured at nine distinct time points: baseline (T0), the intervention phase from Week 1 to Week 7 (T1–T7), and a post-intervention follow-up at Week 9 (T8). This longitudinal schedule is designed to monitor temporal changes in quality of life during the course of radiotherapy and to assess the durability of the intervention’s impact following its completion. Method of measurement: Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Colorectal Cance | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Golnaz Azami
Sanandaj University of Medical Sciences
Outcome results
None listed