Patients with rectal cancer stages II-III Cancer
Conditions
Interventions
Participants are randomized individually in a 1:1 ratio to undergo medicament testing using a nosode of RNA polymerase in C30 dilutions (a homeopathic drug), Ribavirin (Copegus, Roche,200mg tablets),
Sponsors
The Research Institute of Virology of the Republican Specialized Scientific and Practical Medical Center of Epidemiology, Microbiology, Infectious and Parasitic Diseases of the Republic of Uzbekistan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Undergoing outpatient surveillance, of both sexes, over 18 years of age 2.The confirmed diagnosis of rectal cancer stage II-III of the disease 3. The participant signed a written informed consent to participate in the study 4. Patients who responded positively to the RNA polymerase nosode in dilution C30, to drugs Ribavirin and Dexamethasone in the process of medicament testing
Exclusion criteria
Exclusion criteria: 1. Inability or refusal of the patient to comply with the protocol requirements 2. The need to prescribe drugs to the patient that are not allowed for use in the study 3. The occurrence of an adverse event 4. The patient's desire to terminate the study early for any reason 5. Cases not specified in the protocol, when the investigator believes that the patient's continued participation in the study is harmful to them
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall treatment outcome based on the absence of recurrence (local recurrence, distant metastases) of the disease for 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-Reported Outcomes: 1. Quality of Life (QoL): Assessed by using the FACT-C (Functional Assessment of Cancer Treatment – Colorectal) to assess overall well-being. 2. Functional Outcomes: Assess bowel function (including issues like incontinence or constipation), urinary function (including continence or frequency), and sexual function. 3. Symptom Burden: Evaluates the presence and severity of symptoms like pain, fatigue, and other cancer-related symptoms. 4. Patient Satisfaction and Involvement: Evaluates patients' satisfaction with their treatment and their level of involvement in decision-making. Clinical Outcomes: 1. Recurrence: to evaluate the local recurrence (in the rectum), distant recurrence (spread to other parts of the body), and overall recurrence rate. 2. Second Primary Cancers: Monitors for the development of new cancers, including colon cancer, small intestine cancer, and anal cancer. 3. Overall Survival: The time from diagnosis until death from any cause. 4. Disease-Free Survival: The time from diagnosis to the first recurrence of cancer. 5. Tumor Regression Grade (TRG): Assesses the extent of tumor regression after treatment, using the Mandard classification. | — |
Countries
Uzbekistan
Contacts
Public ContactNaylya Djumaeva
Outcome results
None listed