Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03559543|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasm Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasm Rectal Diseases Colonic Diseases Intestinal Disease Gastrointestinal Disease Digestive System Disease||Dietary Supplement: Ocoxin-Viusid||Phase 2|
- To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients.
- To evaluate the influence of Ocoxin®-Viusid® on tolerance to onco-specific therapy.
- Identify the changes that occur in the nutritional status of patients receiving the supplement.
- To evaluate the toxicity of Ocoxin®-Viusid® in combination with chemotherapy in patients with metastatic colorectal adenocarcinoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Effect of the Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Metastatic Colorectal Adenocarcinoma. Phase II|
|Actual Study Start Date :||October 25, 2018|
|Estimated Primary Completion Date :||January 30, 2020|
|Estimated Study Completion Date :||January 30, 2020|
Dietary Supplement: Ocoxin-Viusid
An oral solution of Oncoxin® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and lunch. It will be prescribed for a period of 2 weeks before starting the QT up to 3 weeks after finishing the treatment.
The treatment with Oncoxin®-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment.
The treatment will be administered continuously for approximately 29 weeks from the patient's inclusion in the study.
- Quality of life [ Time Frame: 8 months ]Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: EORTC QLQ-C30 (general quality of life in cancer patients: Physical, Role, Emotional, Cognitive, Social, Overall quality of life, Fatigue, Nausea and vomiting, Pain valorated from 1 to 4)
- Quality of life [ Time Frame: 8 months ]Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: QLQ-CR29 specific questionnaire of quality of life in colon cancer (Urinary frequency, Blood and mucus in stool, Stool frequency and Body image, Urinary incontinence, Dysuria, Abdominal pain, Buttock pain , Bloating, Dry mouth, Hair loss, Taste, Anxiety, Weight, Flatulence, Faecal incontinence, Sore skin, Embarrassment, Stoma care problems, Sexual interest, Impotence, Dyspareunia valorated from 1 to 4).
- Tolerance of Chemotherapy [ Time Frame: 8 months ]Treatment with chemotherapy (CT) FOLFOX-IV will be considered
- Nutritional status [ Time Frame: 8 months ]Variations in the patient's nutritional status and weight at the end of treatment will be considered
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559543
|Contact: Ivis Mendoza Hernández, Msc||7 204 firstname.lastname@example.org|
|Contact: Yaima Muñoz Morejón, Dr.||7 204 email@example.com|
|National Institute of Oncology and Radiobiology (INOR)||Recruiting|
|Havana, Cuba, 10400|
|Contact: Luis E. Alsina Tul, Dr. firstname.lastname@example.org|
|Principal Investigator: Mayte Lima Pérez, Dr.|
|Sub-Investigator: Jorge L. Soriano García, Dr.|
|Principal Investigator: Luis E. Alsina Tul, Dr.|
|Sub-Investigator: Yanelis Mir Espinosa, Dr.|
|Sub-Investigator: Danay Corrales Otero, Dr.|
|Sub-Investigator: Karelia Silvera Candó, BSc|
|Sub-Investigator: Kirenia Silva Rodríguez, BSc|
|Sub-Investigator: Gladys E. García Lemus, NP|
|Sub-Investigator: Zaida Lastres Sosa, BSc|
|Sub-Investigator: Janet Lamadrid García, Dr.|
|Sub-Investigator: Martha I. Lugiollo Lugo, NP|
|Sub-Investigator: Juan J. Lence Anta, Dr.|
|Sub-Investigator: Ana M. Arias Prieto, BSc|
|Sub-Investigator: María E. Suardiaz Espinosa, BSc|
|Sub-Investigator: Martha González Dueñas, NP|
|Sub-Investigator: Luis A. Fuentes Crespo, NP|
|Sub-Investigator: Ana J. Artiles Morales, NP|
|Sub-Investigator: Yolanda Cruz, NP|
|Sub-Investigator: Jorge Ortiz Roque, Dr.|
|Sub-Investigator: Ivelisse Fleites León, BSc|
|Sub-Investigator: Dayanis Duvergel Calderín, Dr.|
|Sub-Investigator: Carlos A. Domínguez Álvarez, Dr.|
|Sub-Investigator: Robin García Diéguez, MSc|