Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia
Condition: Asthenia; Cancer
MeSH terms: Asthenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Nuvastatic TM (C5OSEW5050ESA) 1000 mg
Intervention type(s): Other
Intervention description(s): Nuvastatic TM is a patented polymolecular botanical medicine made from Lanctos 75TM which is a proprietary high potency herbal standardized extract.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment