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Register:	ClinicalTrials.gov
Last refreshed on:	29 June 2015
Main ID:	NCT02468882
Date of registration:	21/05/2015
Prospective Registration:	No
Primary sponsor:	University of Lisbon
Public title:	Does Watercress Intake Have an Impact on Cancer Patients Outcomes: a Longitudinal Trial
Scientific title:	Does Watercress Intake Have an Impact on Cancer Patients Outcomes: a Randomized Longitudinal Trial
Date of first enrolment:	March 2014
Target sample size:	200
Recruitment status:	Recruiting
URL:	http://clinicaltrials.gov/show/NCT02468882
Study type:	Interventional
Study design:	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor)
Phase:	Phase 3

Countries of recruitment
Portugal

Contacts

Name:	Paula Ravasco, PhD
Address:
Telephone:
Email:	p.ravasco@medicina.ulisboa.pt
Affiliation:

Name:	Paula Ravasco, MD PhD
Address:
Telephone:
Email:	p.ravasco@medicina.ulisboa.pt
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- adult breast cancer female patients consecutively referred for primary radiotherapy
with curative intent

Exclusion Criteria:

- pregnancy

- cognitive impairment

- uncooperative or

- patients with any implantable electronic device (e.g. pacemaker) or internal metal
material preventing BIA phase angle assessment

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Long-term Effects Secondary to Cancer Therapy in Adults

Intervention(s)

Dietary Supplement: Watercress

Primary Outcome(s)

Metabolomic profile [Time Frame: Change from baseline at up to 6 weeks]

Nutritional status [Time Frame: Change from baseline at up to 6 weeks]

body composition [Time Frame: Change from baseline at up to 6 weeks]

Carotenoids and flavonoids [Time Frame: Change from baseline at up to 6 weeks]

Quality of Life (QoL) [Time Frame: Change from baseline at up to 6 weeks]

Cell phase angle [Time Frame: Change from baseline at up to 6 weeks]

Dietary intake [Time Frame: Change from baseline at up to 6 weeks]

DNA damage [Time Frame: Change from baseline at up to 6 weeks]

treatments' toxicity and symptoms [Time Frame: up to 6 weeks]

RT induced skin dermitis [Time Frame: up to 6weeks]

Secondary Outcome(s)

Dietary intake 2 [Time Frame: change from 3 months at 3 years]

Metabolomic profile 2 [Time Frame: change from 3 months at 3 years]

Quality of Life 2 (QoL2) [Time Frame: change from 3 months at 3 years]

Cell phase angle 2 [Time Frame: change from 3 months at 3 years]

Nutritional status 2 [Time Frame: change from 3 months at 3 years]

body composition 2 [Time Frame: change from 3 months at 3 years]

Secondary ID(s)

ULisbon

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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