Clinical trial NCT03540407: Evaluation of Oncoxin-Viusid® in Cervical Cancer and Endometrial Adenocarcinoma.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Carcinoma Stage II
Cervical Carcinoma Stage III
Cervical Carcinoma Stage IV
Endometrial Adenocarcinoma Stage II
Endometrial Adenocarcinoma Stage III
Endometrial Adenocarcinoma Stage IV
Keywords: Cervical carcinoma
Endometrial adenocarcinoma
Oncoxin-Viusid
Nutritional supplement
Antioxidant
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Toxicity of chemotherapy and radiotherapy in patients diagnosed with cervical cancer and endometrium adenocarcinoma.
timeFrame: 3 months
Secondary outcomes:
measure: quality of life
timeFrame: 3 months
measure: Reduce hospital costs
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: La Habana
country: Cuba
facility: Ramón González Coro Hospital
Study officials:
affiliation: Ramón González Coro Hospital
name: Raiza Ruiz Llorente, Dr.
role: PRINCIPAL_INVESTIGATOR
References: