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To Compare And Evaluate Side Effect Profile Of Cancer Patients Undergoing Current Treatment along with Food Supplements

An open Label, Prospective , Comparative, Multiple Arm Pilot Study to Compare and Evaluate the Adverse Events Profile of Cancer Patients Undergoing Conventional Treatment Patterns of Chemotherapy and Adding N- 163 and AFO 202 as Adjunct Therapy to Conventional Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032808
Enrollment
40
Registered
2021-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: N- 163 and AFO 202 as Adjunct Therapy: AFO-202: 6g per day (each 2g per meals) N-163: 2 sachets per day (Morning and night) Total duration: 15 days Control Intervention1: N- 163 and

Sponsors

NichiIn Biosciences Pvt Ltd
Lead Sponsor
GN Corporation Co Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65. 2. Patients who diagnosed with breast cancer. 3. Patients who are on 1st and 2nd cycles of chemotherapy. 4. Diagnostic histopathology of Breast Cancer stage II and above. 5. Subjects with any co-morbid conditions can be added. 6. Patient who are willing into participate in the study with a written Informed Consent. Form.

Exclusion criteria

Exclusion criteria: 1. Have previously received any cancer therapy including but not limited to radiotherapy, chemotherapy and surgery. 2. Use of GCSF-Granulokine ® (growth-stimulating factor granulocyte). 3. Use of immunosuppressive drugs, diuretics and supplements of zinc or copper. 4. Use of other supplements during the study duration. 5. Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation. 6. Patients with a history of autoimmune or inflammatory disease, active infectious disease, liver disease or renal failure. 7. Pregnancy (for women of childbearing potential)/lactation. 8. Systemic use of progestinâ??s, androgens or other steroids -dexamethasone is allowed if used as antiemetic therapy.

Design outcomes

Primary

MeasureTime frame
1. Assessment of side effects in different study group. 2. Quality of Life (EORTC QLQ-C30 Questionnaire) (18): Better scores in the questionnaire after intervention Timepoint: Assessment will be done on 15th day of each arm—

Secondary

MeasureTime frame
1. Immunology and Blood parameters Panel (Complete Blood Count, Neutrophils to Lymphocyte ratio, IL6, Tumor Necrosis Factor α, C-Reactive Protein Levels, ESR, FACS for CD56, CD16, CD3, CD4 and CD8 from peripheral blood) Improvement Metrics.Timepoint: Adverse events monitoring every visit—

Countries

India

Contacts

Public ContactDr S R Tiruvalavan

Shanmuga Hospital Pvt Ltd

genmedsiva@gmail.com04272315293

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026