Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04546607
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2020-05-11
Brief Title:
Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia
Sponsor:
Natureceuticals Sdn Bhd
Organization:
Natureceuticals Sdn Bhd
Study Overview
Official Title:
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
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nuvastatic TM C5OSEW5050ESAis 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 ie 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 enrolmentrandomization will be enrolled into either Nuvastatic TM or Placebo group
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 ie 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 enrolmentrandomization will be enrolled into either Nuvastatic TM or Placebo group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None