To study the effects of nutritional supplementation of resveratrol on fatigue and quality of life in patients with advanced cancers undergoing chemotherapy.
- Conditions
- Health Condition 1: null- Patients diagnosed with advanced cancers undergoing non-biological, second-line chemotherapy.
- Registration Number
- CTRI/2017/04/008376
- Lead Sponsor
- Dr Vijay Agarwal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Fatigue measured by Fatigue symptom inventory, <br/ ><br>2) Functional assessment of Cancer Treatment- Fatigue. <br/ ><br>3) Quality of life assessment by FACT-G questionnaire.Timepoint: At weeks - 0, 3, 6, 9, 13, 16 and end of study.
- Secondary Outcome Measures
Name Time Method 1) Safety and tolerance of Resveratrol Incidence and severity of adverse events <br/ ><br>2) Nutritional risk IndexTimepoint: At weeks - 0, 3, 6, 9, 13, 16 and end of study.