Pubblicato su Tumori Journal
di: Camillo Porta, Elena Verzoni, Silvia Zai, Caterina Messina, Vittorio Ferrari, Nicole Gri and Giuseppe Procopio
Background: Stomatitis is highly prevalent in patients with cancer treated with the mammalian target of
rapamycin inhibitor everolimus; it usually has an early onset and may compromise treatment dose intensity and patients’ quality of life. Within the randomized controlled Stomatitis Prevention trial (STOP, ISRCTN14568888), we investigated the possibility of using a commercial natural multicomponent mouthwash (Orasol Plus®) to prevent the development of stomatitis of any grade in patients with advanced renal cell carcinoma (RCC) treated with everolimus.
Methods: Overall, 62 patients were randomized to receive either Orasol Plus in addition to oral hygiene or oral hygiene alone (31 patients per treatment arm).
Results: In the whole study population, 28 episodes of stomatitis were observed (41.9%); in only 2 patients, stomatitis occurred more than once (2 episodes). As expected, the episodes of stomatitis occurred early in the course of treatment with everolimus. Treatment with Orasol Plus prevented the onset of everolimus-induced stomatitis: only 8 episodes of stomatitis were observed in the treated group with Orasol Plus in addition to oral hygiene vs 20 episodes in the group treated with oral hygiene only (p = 0021). Also, a reduction in the average duration of mucositis in patients treated with Orasol Plus compared to patients treated with oral hygiene only was observed (8 days vs 11.2 days, p = 0.0416).
Conclusion: This study showed that the use of a natural multicomponent mouthwash coupled with regular oral hygiene was able to reduce the severity and duration of everolimus-induced stomatitis in patients with RCC.
Trial registration number: ISRCTN14568888
Pubblicato su advances in hematology and oncology research
Breast cancer is the first and most common cancer in women and represents the leading cause of female cancer death. To treat cancer, the treatment that is giving more results is the conventional polychemotherapy with numerous other substances that have specific action, called target therapy. During the treatment of breast cancer, chemotherapy drugs lead to the frequent detection of side effects, first of all, the Oral Mucositis. Oral mucositis (OM) is a common in cancer therapy, found in a percentage of 15-40%, and cause severe sequelae and strong impact on a patient’s quality of life (QoL), health care costs, and ultimately outcome by influencing the treatment dose. There are some and limited therapeutic options to help reduce the severity of OM. Our study evaluated the action of a mix of natural supplements (swallowable solution,
Orasol plus®, for reduction of mucositis during chemotherapy, with Lapacho (Tabebuia Avellanedae Lorentz ex Griseb.), Camellia Sinensis L. Kuntze, Calendula Officinalis L, Malva Sylvestris L, Sisymbrium Officinale (L) Scop, Plantago Major L e Propoli) in 15 breast cancer patients under treatment with chemotherapy and target therapy. No patients had stopped the treatment because of mucositis. From 11 patients that have mucositis during treatment, 5 had complete remission at the and of the first cycle in the 4 patients who took Orasol Plus®, as a preventive measure, none developed mucositis during antiblastic treatments. The data of our study depose for the effectiveness of Orasol Plus® in the treatment of oral mucositis, in patients undergoing chemotherapy for breast cancer. They need a larger study to insert Orasol Plus® in a standardized pathway in the treatment of oral mucositis during chemotherapy.
Lo studio presentato al congresso sio di new york 2019
Use of panax quinquefolius and acetylcarnitine supplement (FORT UP® ) against fatigue in cancer patients admitted to hospice palliative care
Bonucci M.(c); Dell’Arte S.(a); Spinelli G.(b); Siniscalchi A.(a); (a) Department of Palliative Care Oncology – Villa Silvana Hospital – Aprilia – Roma; (b) Department of Oncology – ASL Aprilia – Rome; (c) Outpatient Service of Integrative Oncology – Villa Benedetta Hospital – Rome
For cancer patients fatigue is one of the most frequent and disabling symptoms. Fatigue is a mix of symptoms like muscle pain, mental cognitive dysfunction, neurological disorders that makes the patient completely inactive and into a state of complete abandonment. At this time not exist anything for treatment and today there is no a specific guideline; only a very few substances are able to alleviate this situation. In our study we’re used two scales of VAS to better deeply understand the severity of symptoms. For treatment we used a supplement ( Fort up® – Gamfarma Italy) made with two active principles , panax quinquefolius and acetilcarnitine , in 56 cancer patients admitted to hospice palliative care, administered for three weeks to assess the effect in medium to severe asthenia. Both active principles have demonstrated activity in clinical studies against cancer related fatigue with tonic and energizing action. At the end of study 46 out of 56 patients (82%) had an improvement of symptoms and in 18 patients (4 in low, 11 in medium and 3 in severe asthenia) (32%) these symptoms there resolved. The aim of this study was investigate the efficacy of this product on cancer related fatigue in patients admitted to hospital palliative care. Our study demonstrated that this product can relieve cancer related fatigue in this setting of cancer patients.
Lo studio presentato al congresso sin bologna 2019
Kuzik® was well tolerated: in a numerical scale from 1 to 10 the average score was 9,5 ( range 8 -10) ; the compliance of patients was optimal, no side effect related to product were reported and no weight gain in patients occurred. A clear improvement of the patient’s asthenia should be noted. Regarding efficacy, at the end of treatment , in total population all parameters analyzed were significantly improved.
Our study clearly demonstrated the benefits, safety, and good tolerability of Kuzik® in the prophylaxis of migraine, with and without aura
Lo studio e’ stato presentato come poster ( 289-93) al congresso nazionale sisc napoli 2019
Dall’analisi dei risultati emerge vi è la riduzione uguale o superiore al 50% della frequenza di giorni
cefalea/mese nel 31.7% dei pazienti, una significativa riduzione del consumo medio di analgesici e
del punteggio NRS. Non sono stati riferiti effetti collaterali durante la terapia.
dimostrano l’efficacia del kuzik come trattamento di profilassi per l’ ESA, associata ad una buona
Lo studio e’ stato presentato al congresso stresa headache 2019
Our study clearly demonstrated the benefits, safety, and good tolerability of Kuzik® in the prophylaxis of migraine, with and without aura. This study confirms the data obtained in the previous trial and highlights the positive data obtained with Kuzik® twice daily in patients with chronic disease. The use of this medication should be taken in consideration as a good practice in this setting of patients.
Dysgeusia and nausea are common side effects observed in head and neck cancer patients treated with either exclusive radiotherapy or combined modality treatment. The aim of the present study was to prospectively evaluate dysgeusia, during treatment and follow-up, using the chemotherapy-induced taste alteration scale (CiTAS), a metrics based on 18-items exploring three dimensions (quantitative and qualitative changes in taste perception, and diet-related issues) identified through a four-factor analysis: decline in basic taste, discomfort, phantogeusia–parageusia, and general taste alterations. Moreover,
we scored, according to Common Toxicity Criteria Adverse Events, nausea and other treatment-related toxicities. Since, ginger is traditionally used to prevent and/or treat nausea and vomiting, we prophylactically employed a ginger-based supplement named Naumix/Naugin (Gamfarma, Milan, Italy), to potentially mitigate both nausea and taste impairment. Using the CiTAS scale, we highlighted a progressive increase in all dysgeusia dimensions, peaking at the VII week of treatment and a subsequent partial late recovery. In particular, we observed a recovery for discomfort, phantogeusia–parageusia, and general taste alterations at 6 months. Grade 2 nausea, observed to be as low as 12.9% potentially due to the use of ginger, peaked at
the III week of treatment. Finally, for patients experiencing nausea, the dysgeusia dimension of discomfort was also relevant.
The journal of headache and pain 2017, 18 (suppl 1):111 p187
Efficacy of KUZIK® in the prophylaxis of migraine without aura: a retrospective observational study
A migraine without aura is the most common type of migraine headache (about 60% to 80% of all migraines). In recent years there is growing interest in the use of nutraceuticals for the prevention of migraine, as there are no specific drugs for this indication. A new kudzu based food supplement (Kuzik), thanks to its innovative mechanism of action, has attracted our interest in this use.
Materials and Methods
January and April 2017, 30patients with migraine without aura were treated with Kuzik, once a day for 2 months, recruited in various neurological structures including university centers, general hospitals, territorial structures and private outpatient clinic; for all patients, the diary was completed and full fill the headache card (IHS criteria). Patients were evaluated at baseline and after 2 months regarding number of crisis, headache days and VAS (Visual Analogue Scale): data relative to efficacy and tolerability were collected. Patient’s characteristics: 25 female and 5 male; median age 34 (range 22-56); median years of disease 9,4 (range 2-30) and previous treatments 1,2 (range 1-2). At the baseline average number of crisis was 4 (range 2-10) , headache days 7,4 (range 3-14) and medium VAS 7,1 (range 5-10).
Kuzik was well tolerated: in a numerical scale from 1 to 10 the average score was 8 (range 6 -10); the compliance of patients was optimal, no side effect related to product were reported and no weight gain in patients occurred. Regarding efficacy, at the end of treatment, all parameters analyzed were significantly improved: average number of crisis was 1,2 (range 0-3), headache days 2 (range 0-5) and medium VAS 1,9 (range 0-4) .
Our study has clearly demonstrated the benefits, safety, and good tolerability of Kuzik in the prophylaxis of migraine without aura and the use of this medication should be taken in consideration as a good practice in this setting of patients. Data from our study are encouraging to be confirmed by further investigations.
Pubblicato su medical oncology march 2017, 34:46
Use of an alpha lipoic, methylsulfonylmethane and bromelain dietary supplement (Opera®) for chemotherapy-induced peripheral neuropathy management, a prospective study
Chemotherapy-induced peripheral neuropathy (CIPN) is a major clinical problem associated with a number of cytotoxic agents. OPERA® (GAMFARMA srl, Milan, Italy) is a new dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule. The aim of this prospective study was to determine the efficacy and safety of OPERA® supplementation in a series of patients affected by CIPN. We selected 25 subjects with CIPN evolving during or after chemotherapy with potentially neurotoxic agents. Patients were enrolled at the first clinical manifestation of neuropathy. CIPN was assessed at the enrollment visit and subsequently repeated every 3 weeks until 12 weeks. Primary endpoint was the evaluation of changes of measured scores after 12 weeks of therapy compared to baseline evaluation. Secondary endpoints were the evaluation of neuropathy reduction at 12 weeks after beginning of therapy with OPERA®. Analysis of VAS data showed reduction in pain perceived by patients. According to NCI-CTC sensor and motor score, mISS scale and TNSc scale, both pain and both sensor and motor neuropathic impairment decreased after 12 weeks of treatments. Treatment with OPERA supplement was well tolerated; no increase in the toxicity profile of any of the therapeutic regimen that the patients were undergoing was reported. OPERA® was able to improve CIPN symptoms in a prospective series of patients treated with neurotoxic chemotherapy, with no significant toxicity or interaction. Prospective RCT in a selected patients’ population is warranted to confirm its promising activity.