Table 2.
Clinical trials analyzing the effect of OOS in several cancer models and principal results obtained.
| Study | Findings | Conclusions | Hospitals | Patients | Drugs for Combinations | Reference |
|---|---|---|---|---|---|---|
| OOS given to patients with end-stage hepatocellular carcinoma (HCC) as monotherapy. | Increased survival of patients with end-stage hepatocellular carcinoma due to intake of OOS. | Terminally ill and end stage HCC patients may be managed by food supplements such as OOS and OOS capsules. | Department of Hepatology, Bangabandhu Sheikh Mujib Medical university, Shahbagh, Dhaka, Bangladesh and Department of Medical Sciences, Toshiba General Hospital, Tokio, Japan. | 29 | Monotherapy with OOS and OOS capsules. | NCT 01392131 [79] |
| Patients with terminal stage of hepatocellular carcinoma were studied from the micronutritional point of view after OOS administration. | In patients with terminal stage HCC, OOS improved appetite, quality of life and well-being. OOS also improved overall survival in this group of patients. | The use of micronutrients and aminoacids in cancer patients undergoing chemotherapy is essential to maintain patients quality of life. | Multidisciplinary Oncology Institute, Murcia, Spain. | Not indicated. | Monotherapy with OOS. | [78] |
| Proof of concept study of OOS plus chemo and radiotherapy in patients with Stage IIB-III of cutaneous melanoma. | OOS showed a good safety profile in patients with stage IIB-III cutaneous melanoma. Patients kept a stable quality of life at the end of study and a high progression-free survival rate. | OOS increased progression-free survival rate in cutaneous melanoma. | Department of Dermatology and Infectious Diseases, Manuel Fajardo University Hospital, La Habana, Cuba. Department of Oncology, National Institute of Oncology (INOR), La Habana, Cuba | 20 | Surgery, Interferon, Paclitaxel and Temozolomide. | NCT 03541148 [80] |
| OOS administered with chemo and radiotherapy in gastric cancer IIB-IIIC and non-small cell lung cancer IIB-IIIA was studied from the point of view of quality of life and toxicities induced by cancer therapies. | Toxicity and side effects due to chemotherapy were diminished. | OOS helps to maintain appetite, body mass and quality of life in patients with advanced cancer treated with chemotherapy. | Kazakh Research Institute of Oncology and Radiology, Almaty, Republic of Kazakhstan. Department of Pharmacology and Clinical Pharmacology, Khanty-Mansiysk State Medical Academy, Khanty-Mansiysk, Russia. Department of Chemotherapy, Moscow Clinical Scientific Center n. a. A.S. Loginov, Moscow. | 133 | Xelox or paclitaxel plus carboplatin. | NCT 03550482 [75] |
| Phase II randomised double-blind study of patients with head and neck cancer which undergo cancer protocol therapies associated with OOS. | OOS during radiotherapy or concomitant with chemotherapy in patients with head and neck cancer, improved the quality of life and decreased the number and level of toxicities from these treatments without interfering with their mechanism of action. | OOS had a positive effect on quality of life in patients treated with radio/chemotherapy. | Department of Otolaryngology, Radiotherapy and Chemotherapy, National Institute of Oncology and Radiobiology (INOR), La Habana, Cuba. | 60 | Radiotherapy and Cisplatin. | NCT 03541772 [74] |
| OOS in the Management of chemotherapy – and or radiotherapy-associated oral mucositis. | OOS rapidly improved oral mucositis, as measured by the WHO Oral Toxicity Scale, maintained body mass and decreased the toxicity of anticancer therapy. | OOS helped to maintain normal eating habits and decreased side effects of radio/chemotherapy. | Medical Scientific Centre of Professor Shumsky, Samara, Russia. Khanty-Mansiysk Regional Hospital, Khanty-Mansiysk, Russia. | 15 | Monotherapy with OOS. | NCT 03577535 [76] |
| Findings of the 3 months supportive treatment with OOS beside the standard modalities of patients with different neoplastic diseases. | OOS along with protocol anticancer therapy improved the quality of life of patients with head and neck, breast and cervix cancer. OOS decreased episodes of depression and increased optimism. OOS reduced toxicities due to chemo and radiotherapies and increased survival rates. | The administration of OOS along with conventional chemo and radiotherapy lead to relevant anti-tumor synergy as well as to the inhibition of conventional therapy’s toxicity. | Department of Radiotherapy, Rajshahi Medical College, Rajshahi, Bangladesh. | 90 | Conventional radiotherapy and chemotherapy for head and neck, breast and cervix cancer. | [81] |
| Efficacy of OOS-VIUSID on the reduction of adverse reactions to chemotherapy and radiotherapy in patients diagnosed with cervical cancer and endometrial adenocarcinoma. | OOS-VIUSID significantly reduced the number of patients who suffered adverse events to onco-specific treatment. OOS-VIUSID stopped the fall in haemoglobin levels, and platelet and leukocyte counts, compared to patients receiving traditional treatment. | The administration of OOS along with chemo and radiotherapy lead to inhibition of conventional therapy’s toxicity and consequently less interruption of the cancer treatments. | Hospital Ramón González Coro, La Habana, Cuba. National Institute of Oncology and Radiobiology (INOR), La Habana, Cuba. | 63 | Radiotherapy and Cisplatin | NCT 03540407 [77] |