Health Condition 1: null- Patients diagnosed with advanced cancers undergoing non-biological, second-line chemotherapy.
Conditions
Interventions
Intervention1: Resveratrol: Nutraceutical
Intervention2: Resveratrol: Nutraceutical
Intervention3: Placebo: Placebo
Control Intervention1: Placebo: Placebo
Control Intervention2: Not applicable: Not a
Sponsors
Dr Vijay Agarwal
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be male or female >= 18 years at the time of signing Informed Consent. 2. Patients previously diagnosed with advanced cancers. 3. Patient must have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described. 4. Patient must have a life expectancy of greater than 3 months. 5. Patient has an ECOG Performance status of 0 to 2. 6. Patient must be able to adhere to the study visit schedule and other protocol requirements. 7. Patient must understand and voluntarily sign an informed consent document. 8. Patients should be medically fit to receive chemotherapy. 9. All patients of reproductive potential must agree prior to study entry to use adequate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with endometrial, breast, prostate and ovarian cancers. 2. Ongoing artificial nutrition (enteral or parenteral). 3. No concurrent known appetite stimulants (e.g., megestrol or dronabinol). 4. No concurrent omega 3 fatty acids or their congeners (e.g., ProSure•). 5. No concurrent amino acid supplements. 6. Concurrent use of other dietary supplements. 7. Patient has a history / evidence of allergy or hypersensitivity to resveratrol. 8. Patient has had a major illness (other than cancer) in the past three months or any significant ongoing chronic medical illness that the Investigator would deem unfavourable for enrolment. 9. Patient has a history of or current gastro-intestinal diseases influencing drug absorption. 10. Patients with uncontrolled bleeding of any origin. 11. Patient has brain metastases or central nervous system disease. 12. Patients currently taking any investigational therapies and/or dietary supplements containing resveratrol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Fatigue measured by Fatigue symptom inventory, 2) Functional assessment of Cancer Treatment- Fatigue. 3) Quality of life assessment by FACT-G questionnaire.Timepoint: At weeks - 0, 3, 6, 9, 13, 16 and end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety and tolerance of Resveratrol Incidence and severity of adverse events 2) Nutritional risk IndexTimepoint: At weeks - 0, 3, 6, 9, 13, 16 and end of study. | — |
Countries
India
Contacts
Public ContactDr Surinder Kher
Triesta Sciences
Outcome results
None listed