AstheniaPhase 2/3NCT04546607

Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia

A Phase 2/3 study testing Nuvastatic TM (C5OSEW5050ESA) 1000 mg in people with Asthenia and Cancer, run by Natureceuticals Sdn Bhd at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthenia, Cancer
What is being tested?: Nuvastatic TM (C5OSEW5050ESA) 1000 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: 1 siteIndia
Study dates: 2 Sep 2017to 31 Oct 2019
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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:
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.

Trial locations and contacts

1 site in 1 country.

India1 site

Notrox Research Pvt Ltd
Bangalore, Karnataka, 560062

Other trials in India

About this study

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

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.

Read the 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
Being tested: Nuvastatic TM (C5OSEW5050ESA) 1000 mg
Medical subject headings: Asthenia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04546607
Study group	Role	What they receive
Nuvastatic TM	Experimental	Nuvastatic TM (C5OSEW5050ESA) capsule 1000 mg administered orally 3 times a day for 9 weeks. Receives: Other: Nuvastatic TM (C5OSEW5050ESA) 1000 mg
Placebo	Placebo comparator	Excipient, without Nuvastatic TM (C5OSEW5050ESA) capsule administered orally 3 times a day for 9 weeks. Receives: Other: Nuvastatic TM (C5OSEW5050ESA) 1000 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: 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: 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: 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: 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: 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: 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: Measured at Visit 9 (week 9)

Secondary outcomes (6)

Quality of Life (QoL)
Overall QoL improvement using EORTC-QLQ-C30. Scale 1 (worse) to 10 (better).
Measured: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
Fatigue Severity Scale
Fatigue Severity Scale (FSS). Scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Measured: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
Brief Fatigue Inventory
Brief Fatigue Inventory. 11-point rating scale developed to assess subjective fatigue. Fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels.
Measured: 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)
Vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36). Scale ranging from 0 (worst possible health state) to 100 (best possible health state).
Measured: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
F2-isoprostane
urinary F2-isoprostane as a biomarker for fatigue reduction
Measured: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
The adverse events
The occurrence and severity of adverse effects are measured by a severity score scale and system organ class (gastrointestinal disorders, general disorders, and administration site conditions, nervous system disorders) in treatment vs placebo group.
Measured: During 9 weeks intervention and at end of intervation on 9th week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 201731 Oct 2019

First posted14 Sep 2020
Study start2 Sep 2017
Primary completion28 Oct 2019
Study completion31 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AstheniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Investigator
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04546607
Sponsor's protocol ID: EBSB0045011CRA
Status last verified: Sep 2020
First submitted: 11 May 2020
Last updated: 16 Sep 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38710920

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04546607
Acronym / sponsor ID: EBSB0045011CRA
Conditions: Asthenia, Cancer
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Natureceuticals Sdn BhdIndustry (pharma, biotech, devices)
Study start: 2 Sep 2017 (actual)
Primary completion: 28 Oct 2019 (actual)
Study completion: 31 Oct 2019 (actual)
First posted: 14 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Nuvastatic TM	Experimental	Other: Nuvastatic TM (C5OSEW5050ESA) 1000 mgNuvastatic TM (C5OSEW5050ESA) capsule 1000 mg administered orally 3 times a day for 9 weeks.
Placebo	Placebo comparator	Other: Nuvastatic TM (C5OSEW5050ESA) 1000 mgExcipient, without Nuvastatic TM (C5OSEW5050ESA) capsule administered orally 3 times a day for 9 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nuvastatic TM (C5OSEW5050ESA) 1000 mgNuvastatic TM is a patented polymolecular botanical medicine made from Lanctos 75TM which is a proprietary high potency herbal standardized extract.	Other	Nuvastatic TM, Placebo

Primary outcome

To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Improving Fatigue in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at baseline (Visit 2) (week 2)
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)
To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Improving Fatigue in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at Visit 3 (week 3)
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)
To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Improving Fatigue in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at Visit 6 (week 6)
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)
To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Improving Fatigue in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at Visit 9 (week 9)
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)
To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at baseline (Visit 2) (week 2)
Visual Analogue fatigue scale (VAFS) as primary endpoint. Fatigue with 0 being worst and 10 being normal.
To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at Visit 3 (week 3)
Visual Analogue fatigue scale (VAFS) as primary endpoint. Fatigue with 0 being worst and 10 being normal.
To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at Visit 6 (week 6)
Visual Analogue fatigue scale (VAFS) as primary endpoint. Fatigue with 0 being worst and 10 being normal.
To evaluate the safety and tolerability of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Patients with Solid Stage I - IV Tumors.
Time frame: Measured at Visit 9 (week 9)
Visual Analogue fatigue scale (VAFS) as primary endpoint. Fatigue with 0 being worst and 10 being normal.

6 secondary outcomes

Quality of Life (QoL)
Time frame: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
Fatigue Severity Scale
Time frame: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
Brief Fatigue Inventory
Time frame: 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)
Time frame: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
F2-isoprostane
Time frame: Measured at baseline (visit 2) (week 2), visit 3 (week 3), visit 4 (week 6), and visit 5 (week 9).
The adverse events
Time frame: During 9 weeks intervention and at end of intervation on 9th week.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Derived from this study: PubMed 38710920Ng 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ghanashyam Biswas, PHD principal investigator

Sparsh Hospitals & Critical Care Pvt. Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nuvastatic TM (C5OSEW5050ESA) 1000 mg in people with Asthenia and Cancer, run by Natureceuticals Sdn Bhd at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate efficacy of CANSSUFIVE® Nuvastatic (C5OSEW5050ESA) in Improving Fatigue in Patients with Solid Stage I - IV Tumors. (time frame: Measured at baseline (Visit 2) (week 2)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04546607, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.