Symptoms and General Pathology

All Conditions

Asthenia

Fatigue

Nuvastatic TM (C5OSEW5050ESA) capsule 1000 mg administered orally 3 times a day for 9 weeks.

Excipient, without Nuvastatic TM (C5OSEW5050ESA) capsule administered orally 3 times a day for 9 weeks.

Nuvastatic TM is a patented polymolecular botanical medicine made from Lanctos 75TM which is a proprietary high potency herbal standardized extract.

Nuvastatic TM (C5OSEW5050ESA) 1000 mg

Ghanashyam Biswas, PHD

Nuvastatic TM (C5OSEW5050ESA)is a special formulation derived from the standardized extract of O. stamineus leaves developed by Natureceuticals Sdn. Bhd. The extract is prepared from meticulous extraction using sophisticated phytochemical techniques, where the particular phytopharmaceuticals (active ingredients) are being concentrated to achieve the desired therapeutic efficacy. In the proposed human study, it is anticipated that administering dietary supplement of standardized O. stamineus rosmarinic acid-enriched Nuvastatic TM (C5OSEW5050ESA) 1000 mg (3 times a day), can ameliorate fatigue in cancer patients. This is based on scientific studies that support its ability in reducing oxidative damage and restore mitochondrial and other cellular functions involved in cellular energy production. It is further hypothesized that the anti-inflammatory, antinociceptive anti-oxidant, and neuroprotective properties of the active compound rosmarinic acid may also potentially assist in pain control, sleep loss, lethargy and other symptoms strongly associated with cancer-related fatigue.

All stage I-IV solid tumors patients are planned to receive or already receiving chemotherapy or radiotherapy including palliative chemotherapy and radiotherapy meeting the eligibility criteria will be consented and pre-screened for fatigue using Brief Fatigue Inventory (BFI). Subjects will be administered a BFI questionnaire prior to the commencement of their chemotherapy (preferably 1st chemotherapy cycle) or radiotherapy treatment.

Patients will be assessed again using the BFI questionnaire on day 1 of their next chemotherapy cycle or the following week of radiotherapy. Patients will not be considered for study enrolment if the fatigue severity does not increase by at least one score from the previous assessment during the pre-screening. Those with newly developed fatigue or worsening of their fatigue score (i.e. from moderate to severe, mild to moderate, or mild to severe) will be consented for study enrolment. The subject who signed informed consent, pre-screened and is subsequently eligible for study enrolment/randomization will be enrolled into either Nuvastatic TM or Placebo group

Randomized, Parallel Group, Placebo Controlled Trial. the study was intervention type, in which different cancer patients were administered with relevant chemotherapeutic drugs + Nuvastatic. The drug-type of Nuvastatic is a botanical drug which was used as chemo-adjuvant.

Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel, Study Assessing NuvastaticTM (C5OSEW5050ESA) 1000 mg (3 Times a Day) in Improving Fatigue in Patients With Solid Stage I - IV Tumors

Functional Assessment of Chronic Illness Therapy Fatigue FACIT-F scale as primary endpoint. FACIT-Fatigue Scale: (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much)

Visual Analogue fatigue scale (VAFS) as primary endpoint. Fatigue with 0 being worst and 10 being normal.

Overall QoL improvement using EORTC-QLQ-C30. Scale 1 (worse) to 10 (better).

Fatigue Severity Scale (FSS). Scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").

Brief Fatigue Inventory. 11-point rating scale developed to assess subjective fatigue. Fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels.

Vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36). Scale ranging from 0 (worst possible health state) to 100 (best possible health state).

urinary F2-isoprostane as a biomarker for fatigue reduction

The occurrence and severity of adverse effects are measured by a severity score scale and system organ class (gastrointestinal disorders, general disorders, and administration site conditions, nervous system disorders) in treatment vs placebo group.

Natureceuticals Sdn Bhd

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

methylphenidate (pill) p.o. 15 to 25 mg daily for six days

the same number of pills (p.o.) than methylphenidate for six days

methylphenidate

placebo

Carlos Centeno Cortes, MD, Phd

Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central nervous system stimulant that has traditionally been used in cancer patients to manage depression, opioid-induced sedation, hypoactive delirium due to multiorgan failure, and cognitive disorder associated with brain tumors. Although there is evidence from prospective studies of the efficacy of this drug in cancer-related fatigue, the only one randomised clinical trials gave non-conclusive results. In order to define the real efficacy of methylphenidate in this setting, the investigators designed a new clinical trial comparing methylphenidate and placebo in cancer-related fatigue, assessed both by the verbal numeric scale (VNS) included in the Edmonton Symptom Assessment System (ESAS) and the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F). The investigators will include 122 advanced cancer patients with fatigue ≥ 5/10 (VNS, from 0 to 10) and hemoglobin ≥ 9 g/dl. Patients will be randomized to methylphenidate or placebo. Doses will be adapted to response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day. Assessment of response will be performed on day 3 and day 6 with ESAS and FACT-F. Drug-induced adverse events will be checked. The VNS of fatigue on day 6 will be consider the primary endpoint.

Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients

Double-blind, Placebo-controlled, Multicenter Randomized Clinical Trial to Evaluate Short-term Efficacy of Palliative Treatment With Methylphenidate in Asthenia in Advanced Cancer Patients

We are looking for a difference between goups (methylphenidate versus placebo) of 1.5 (numeric rating scale: o to 10)

We will check for methylphenidate-related adverse events as: restlessness, hyperactivity, hyporexia, nausea and vomiting, dry mouth, palpitations, sleep insomnia, cephalea, muscle cramps, tics, and any other adverse event that could be treatment-related according to investigator. We will include the severity of the adverse event (mild, moderate, or severe), the presumed relationship with treatment, the measured required to treat it, and the final outcome.

We use a specific questionnaire. In order to facilitate its use in fatigued patients it is designed with a limited number of items selected from three validated tools as MMSE, 3MS, and RBANS

Clinica Universidad de Navarra, Universidad de Navarra

methylphenidate at 20mg per day during 7 days, at 20mg or 40mg per day during 7 days and 20, 40 or 60mg per day during 14 days

methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days

placebo comparator

Guillemette Laval, M.D., Ph.D.

The aim/objective of this study is to evaluate the antiasthenic effect of methylphenidate with a visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in palliative care, i.e. with a progressive or terminal disease.

Cancer patients in an advanced phase or who are terminally ill generally present with depression, pain, drowsiness, alterations of cognition, anorexia and other symptoms due to the progressive disease. The objective of the medical team of support and palliative care is to control these effects to maintain a quality of life. Particularly, the cancer patient in an advanced phase of the disease presents with important asthenia. In some patients, this asthenia is characterized by drowsiness or apathy. It always leads to ill-being and a sensation of bad adaptation. When an etiologic treatment is possible (correction of the anaemia, of the metabolic disorders, of the undernutrition, of the anorexia, of the insomnia, of the stubborn pain, of the psychological suffering), the asthenia can be fought. But, when it appears in patients not really in the end of life (life expectancy more than 1 month) and when no etiologic treatments are possible, other solutions must be considered, and all the more when the complaint is important with repeated requests for relief.

Methylphenidate is an amphetamine first indicated for deficient attention disorders with hyperactivity in children more than 6 years old. Several studies have been realized to evaluate its effect in cancer patients in palliative care. Some studies showed, in particular, its effectiveness on asthenia because of a stimulant and an antidepressant action. The methylphenidate could have an anti-analgesic effect or co-analgesic effect. All these studies are observational and not randomized. So they have a small level of proof and they have not been realized in a population of asthenic patients in palliative care. So a randomized controlled clinical trial in this specific population needs to be experimented.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia	NCT04546607	Asthenia Cancer	Nuvastatic TM (...	18 Years - 65 Years	Natureceuticals Sdn Bhd
Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients	NCT01773837	Asthenia	methylphenidate placebo	18 Years -	Clinica Universidad de Navarra, Universidad de Navarra
Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients	NCT01773837	Asthenia	methylphenidate placebo	18 Years -	Clinica Universidad de Navarra, Universidad de Navarra
Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients	NCT00273741	Asthenia Neoplasms	methylphenidate placebo compara...	18 Years - 75 Years	University Hospital, Grenoble

Spots Global Cancer Trial Database for asthenia

Every month we try and update this database with for asthenia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for asthenia

Every month we try and update this database with for asthenia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for asthenia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.