NCT04546607

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Natureceuticals Sdn Bhd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthenia
• Cancer

Interventions

Type	Name	Description
OTHER	Nuvastatic TM (C5OSEW5050ESA) 1000 mg	Nuvastatic TM is a patented polymolecular botanical medicine made from Lanctos 75TM which is a proprietary high potency herbal standardized extract.

Timeline

• Start date: 2017-09-02
• Primary completion: 2019-10-28
• Completion: 2019-10-31
• First posted: 2020-09-14
• Last updated: 2020-09-16

Locations

1 site across 1 country: India