Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia

NCT04546607 | Completed Phase 2 DMC

• 1 other identifier: EBSB0045011CRA
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthenia; Cancer

Outcome Measures

Primary Outcomes (8)

• To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) 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)

  Measured at baseline (Visit 2) (week 2)

• To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) 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)

  Measured at Visit 3 (week 3)

• To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) 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)

  Measured at Visit 6 (week 6)

• To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) 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)

  Measured at Visit 9 (week 9)

• To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.

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

  Measured at baseline (Visit 2) (week 2)

• To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.

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

  Measured at Visit 3 (week 3)

• To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.

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

  Measured at Visit 6 (week 6)

• To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.

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

  Measured at Visit 9 (week 9)

Secondary Outcomes (6)

• Quality of Life (QoL)

  Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).

• Fatigue Severity Scale

  Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).

• Brief Fatigue Inventory

  Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).

• Vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36)

  Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).

• F2-isoprostane

  Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).

Study Arms (2)

Nuvastatic TM

EXPERIMENTAL

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

Other: Nuvastatic TM (C5OSEW5050ESA) 1000 mg

Placebo

PLACEBO COMPARATOR

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

Other: Nuvastatic TM (C5OSEW5050ESA) 1000 mg

Interventions

Nuvastatic TM (C5OSEW5050ESA) 1000 mg OTHER

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

Nuvastatic TM; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.
• 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
• 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.

Sponsors & Collaborators

• Natureceuticals Sdn Bhd: lead

Study Sites (1)

Notrox Research Pvt Ltd

Bangalore, Karnataka, 560062, India

Location

Related Publications (1)

• Ng ML, Majid AMSA, Yee SM, Natesan V, Basheer MKA, Gnanasekaran A, Al-Suede FSR, Parish C, Dalal M, Ming LC, Nazari V M, Khan SS, Stn Hameed Sultan SB, Babu KG, Majid ASA, Abdul Aziz MAS. A phase II randomized, double-blind, placebo-controlled study of Nuvastatic (C50SEW505OESA), a standardized rosmarinic acid-rich polymolecular botanical extract formulation to reduce cancer-related fatigue in patients with solid tumors. Support Care Cancer. 2024 May 6;32(6):331. doi: 10.1007/s00520-024-08536-w.

  PMID: 38710920 DERIVED

MeSH Terms

Conditions

Asthenia; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghanashyam Biswas, PHD

  Sparsh Hospitals & Critical Care Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and Investigator Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: September 14, 2020
• Study Start: September 2, 2017
• Primary Completion: October 28, 2019
• Study Completion: October 31, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)