Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia

Brief Title

Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia

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

Brief 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
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Improving Fatigue in Patients with Solid Stage I - IV Tumors.

Secondary Outcome

 Quality of Life (QoL)

Condition

Asthenia

Intervention

Nuvastatic TM (C5OSEW5050ESA) 1000 mg

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

110

Start Date

September 2, 2017

Completion Date

October 31, 2019

Primary Completion Date

October 28, 2019

Eligibility Criteria

        Inclusion Criteria:

        Males or females, ≥ age 18 Patients with solid tumors, Stage I-IV Patients who received,
        receiving, or plan to receive chemotherapy and/or ≥ 1 week of radiotherapy.

        ECOG 0-2 Life expectancy ≥ 6 months Ability and willingness to provide written informed
        consent and comply with study requirement

        Exclusion Criteria:

          1. Known allergy to Nuvastatic TM (C5OSEW5050ESA) or any of the excipient used in the
             preparation of the investigational product 2. Any other known existing condition that
             contraindicates with the use of investigational product 3. Inability to take or
             consume the investigational product per protocol-specified route of administration
             including peptic ulcer disease, chronic gastritis, hypotension, and systolic blood
             pressure <90mmgHg.

          2. Inability to understand local language (s) for which BFI, EORTC-QLQ- C30, FACIT-F,
             visual analogue scale for fatigue questionnaire 5. Any condition (e.g. Psychological,
             geographical, etc.) that does not permit compliance with the study or follow up
             procedures 6. Participation in any other clinical study using an investigational
             medicinal product or device within 28 days prior to baseline visit 7. Treatment with
             medications or supplements frequently associated with fatigue, such as interferon
             (within the last four months), beta-blockers, calcium channel blockers,
             benzodiazepines, sedating antihistamines, antidepressants, antipsychotics, or
             melatonin. In select instances, patients using these medications may be enrolled if,
             in the opinion of the investigators, their fatigue is clearly unrelated to the
             medication.

          3. Untreated or uncontrolled comorbidities that influence fatigue, including thyroid
             disorders (TSH> 5 mcIU/mL), anemia (Hemoglobin< 9 g/dL), major depression, active
             substance abuse, or other conditions as determined by the enrolling physician.
             Comorbidities that are adequately controlled will not exclude patients.

          4. Chronic renal failure patients with raised serum potassium levels and abnormal renal
             function 10. Untreated sleep disorders such as obstructive sleep apnea or restless leg
             syndrome 11. Decompensated cirrhosis (encephalopathy, gastrointestinal bleeding,
             ascites, bilirubin > 2) within the last six months 12. Patients planning to travel
             outside the time zone during the study period 13. Known or suspected significant
             gastrointestinal motility disorder, obstruction, or structuring disease 14. Severe
             malnutrition according to WHO criteria. 15. Upon examination, the patients may be
             deemed to have any of the following conditions:

             a. Bipedal edema b. Visible severe wasting c. Weight for height more than 3 standard
             deviations below the median of international reference population d. Fever related to
             systemic infection (especially Gram-negative coliforms such as Escherichia coli and
             Klebsiellapneumoniae), neutropenic sepsis e. Respiratory distress f. Heart failure g.
             Electrolyte abnormalities (hypophosphataemia, hypokalemia/ hyperkaliemia,
             hypoglycemia, etc.) h. Marked anorexia i. Profuse diarrhea j. Shock

          5. The patient is female and is pregnant or fertile and is not practicing adequate
             methods of contraception, is planning to become pregnant within 1 month of the study,
             is breastfeeding. Note: Females who are breastfeeding should not be discouraged from
             breastfeeding for the sole purpose of enrolling in the study. Females who choose to
             defer breastfeeding until 5 days after the last dose of study drug to allow the
             elimination of the drug from breast milk will be eligible.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ghanashyam Biswas, PHD, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT04546607

Organization ID

EBSB0045011CRA


Responsible Party

Sponsor

Study Sponsor

Natureceuticals Sdn Bhd


Study Sponsor

Ghanashyam Biswas, PHD, Principal Investigator, Sparsh Hospitals & Critical Care Pvt. Ltd.


Verification Date

September 2020