Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients will be evaluated clinically and hematological at the beginning of the treatment, before each cycle of treatment with QTP / RTP, at month, two and three months after the end of the treatment with follow-up every three months for 1 year. The self-perceived quality of life related to health will be assessed by means of the EORTC questionnaires (QLQ-C30 and the specific questionnaire QLQ-CX24) at the beginning and a year after completing the treatment. The toxicity to the research product will be described according to Common Criteria of Terminology for the Report of Adverse Events (CTCAE version 4) and the tolerance to onco-specific treatment. It is expected that with the joint administration of the research product, the patients will have a better tolerance to the treatment of QTP / RTP with a decrease of the interruptions by toxicity in 25% and will preserve a better quality of life.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncoxin-Viusid® | Experimental | will receive the Oncoxin-Viusid® (oral solution) concomitant to the onco-specific treatment. |
|
| Placebo | Placebo Comparator | will receive a Placebo concomitant to the onco-specific treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncoxin-Viusid® | Dietary Supplement | Administration of the Oncoxin-Viusid® oral solution 25 mL three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
women
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raiza Ruiz Llorente, Dr. | Ramón González Coro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramón González Coro Hospital | La Habana | 10400 | Cuba |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A double blind
| Placebo | Dietary Supplement | Administration of the Oncoxin-Viusid® oral solution placebo 25 ml three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment |
|
| 3 months |
| 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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided