Cervical Carcinoma Stage II Clinical Trial
Official title:
Efficacy of the Oncoxin-Viusid® Oral Solution in Reducing the Adverse Reactions of Chemotherapy and Radiotherapy in Patients Diagnosed With Cervical Cancer and Endometrial Adenocarcinoma.
| Verified date | January 2020 |
| Source | Catalysis SL |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy of oral solution Oncoxin-Viusid in the reduction of acute toxicity of Radiotherapy (RTP) and Chemotherapy (QTP) in patients with histological diagnosis of cervical cancer and endometrial adenocarcinoma. This is a phase II, prospective, randomized and double blind clinical trial, which will include 66 patients assigned to 2 treatment arms: 33 patients will receive conventional treatment, plus a placebo of the nutritional supplement and another 33 patients will receive along with the conventional treatment the Oncoxin-Viusid nutritional supplement produced by the Catalysis Laboratories of Spain. Patients will receive oral treatment throughout the onco-specific treatment and up to 3 weeks after completion.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | September 30, 2019 |
| Est. primary completion date | February 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients with histological confirmation of cervical cancer and adenocarcinoma of the endometrium that are treated with chemotherapy and ionizing radiation. - Patient with age equal to or greater than 18 years and up to 80 years. - Patients who do not present decompensated concurrent diseases at the time of diagnosis that prevent or contraindicate the application of treatment with chemo-radiotherapy. - Informed consent to participate in the investigation. - Patients with an ECOG <or equal to 3. Exclusion Criteria: - Patients with a history of renal failure that contraindicates the administration of cisplatin. - Concomitant diseases unbalanced at the time of diagnosis or during the application of treatment. - Patients with an ECOG> 3. - Pregnant or lactating women. - Patients who are receiving another research product. - Patients who do not show consent to participate in the study. |
| Country | Name | City | State |
|---|---|---|---|
| Cuba | Ramón González Coro Hospital | La Habana |
| Lead Sponsor | Collaborator |
|---|---|
| Catalysis SL |
Cuba,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Toxicity of chemotherapy and radiotherapy in patients diagnosed with cervical cancer and endometrium adenocarcinoma. | Patients diagnosed with cervical cancer and adenocarcinoma of the endometrium usually have varying degrees of malnutrition and immunodeficiencies; they are carriers of oncogenic virus infections, and present deterioration of their general state, depression-anxiety and socio-economic dysfunctions. Oncospecific treatment's toxicity is measured according to Common Criteria of Terminology for the Report of Adverse Events (CTCAE version 4). | 3 months | |
| Secondary | quality of life | Self-perceived quality of life related to health through the EORTC test QLQ-C30 at the beginning and at the end of the treatment. | 3 months | |
| Secondary | Reduce hospital costs | Reduce hospital costs by being unnecessary or decreasing, the use of concomitant support treatments that counteract the adverse effects caused by these, hospitalization for the treatment of complications secondary to the treatment of QTP / RTP and the use of antibiotics in cases of neutropenia / leukopenia and sepsis added, very frequent in these patients. | 3 months | |
| Secondary | Quality of life | Self-perceived quality of life related to health through the EORTC test QLQ-CX24 at the beginning and at the end of the treatment | 3 months |