A Phase 2 interventional study of Oncoxin-Viusid® and Placebo in Cervical Carcinoma Stage II, Cervical Carcinoma Stage III and Cervical Carcinoma Stage IV, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by Catalysis SL · Phase 2, Interventional, and Supportive care
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 66 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
will receive the Oncoxin-Viusid® (oral solution) concomitant to the onco-specific treatment.
Dietary Supplement: Oncoxin-Viusid®
will receive a Placebo concomitant to the onco-specific treatment
Dietary Supplement: Placebo
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
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
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).
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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