Does Watercress Intake Have an Impact on Cancer Patients Outcomes: a Longitudinal Trial

NCT02468882 | Unknown Phase 3

• 1 other identifier: ULisbon
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Population studies associate a higher intake of cruciferous vegetables with a reduced risk of cancer. Studies identified PEITC and several active isothiocyanates in watercress extract that may have significant anticarcinogenic activity. Potential anticarcinogenic mechanisms include: preventing carcinogen activation by inhibiting phase I enzymes such as cytochrome P450s, by increasing cells' resistance through detoxification/antioxidant enzymes, by inhibiting cell cycle progression and/or by inducing apoptosis. These findings are justifiably interesting for the primary care setting and cancer primary prevention. Yet, these cellular effects of watercress supplementation may further prove useful in the modulation of cancer progression and disease recurrence. The present clinical trial of nutritional supplementation in cancer, intends to further explore the effects of therapeutic diets supplemented with nutraceuticals via watercress that may prove useful in DNA damage modulation, as well as in the global disease prognosis.

Conditions

Long-term Effects Secondary to Cancer Therapy in Adults

Keywords

Breast cancer; Radiotherapy; Toxicity; Outcomes; Watercress

Outcome Measures

Primary Outcomes (10)

• Cell phase angle

  as an indirect measure of cell membrane integrity, function and metabolism

  Change from baseline at up to 6 weeks

• body composition

  assessed by tetrapolar multifrequency Bioimpedance Analysis (BIA) and CT scan images; CT scans analysis will be performed in collaboration with expert groups

  Change from baseline at up to 6 weeks

• treatments' toxicity and symptoms

  Assessed by the RTOG Common Toxicity Criteria, developed by the Eastern Cooperative Oncology Group (RTOG)

  up to 6 weeks

• RT induced skin dermitis

  Evaluated by a radiation oncologist, using a validated toxicity scale

  up to 6weeks

• Quality of Life (QoL)

  will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30), validated for Oncology

  Change from baseline at up to 6 weeks

• DNA damage

  DNA damage assessment by Comet assay in lymphocytes has been used extensively as a surrogate biomarker to measure exposure to genotoxic agents and assess cancer risk in human studies by us and others. biological samples will comprise serum or plasma (1 mL) prepared from blood samples collected in Heparin tubes and urine (1 mL). Metabolomic profiles will be measured on a 700 MHz 1H NMR spectrometer equipped with a cryo-probe for enhanced sensitivity. 1H NMR spectroscopy: high throughput metabolic phenotyping is a powerful approach for characterising biochemical signatures of biological samples. We will couple high-resolution 1H NMR spectroscopy and mathematical modelling approaches to determine the metabolic profile in biological samples from patients.

  Change from baseline at up to 6 weeks

• Metabolomic profile

  Metabolomics simultaneously measures thousands of low molecular weight metabolites providing holistic information on the biochemical status of the body. Previous metabolomic studies have identified cancer-associated perturbations in the metabolic phenotypes of patients. This study will explore the ability of watercress to improve the restorative effects of radiotherapy in breast cancer patients on the metabolic status towards a healthy phenotype

  Change from baseline at up to 6 weeks

• Nutritional status

  assessed by the method Patient-Generated Subjective Global Assessment, specific and validated for Oncology

  Change from baseline at up to 6 weeks

• Dietary intake

  Will derive from a diet history and a 24-hour-recall food questionnaire. The software Dietplan6 (Forestfield Software Ltd 2013®, Horsham, UK) will analyze the nutrient content of foods consumed

  Change from baseline at up to 6 weeks

• Carotenoids and flavonoids

  The plasma samples analysis will also include the measurement of carotenoids and flavonoids, which are present in watercress, and are related with antigenotoxic effects in vitro and have anti-proliferative effects, as demonstrated in several studies. Urine samples analysis will allow the measurement of flavonoids.

  Change from baseline at up to 6 weeks

Secondary Outcomes (6)

• Cell phase angle 2

  change from 3 months at 3 years

• body composition 2

  change from 3 months at 3 years

• Quality of Life 2 (QoL2)

  change from 3 months at 3 years

• Metabolomic profile 2

  change from 3 months at 3 years

• Nutritional status 2

  change from 3 months at 3 years

Study Arms (2)

Intervention group

EXPERIMENTAL

Watercress will be tested in its natural form as a food item that will supplement the usual diet, via the prescription of watercress as whole food added daily to the usual diet. The intervention group will be asked to consume 100 grams of watercress per day, in addition to their usual diet for the total time of RT treatment. These 100 grams of watercress per day will allow the achievement of the daily "therapeutic" dose.

Dietary Supplement: Watercress

Control group

NO INTERVENTION

The control group will receive the standard of care, thus will maintain their ad libitum diet.

Interventions

Watercress DIETARY_SUPPLEMENT

100g of watercress daily during radiation therapy

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy
• cognitive impairment
• uncooperative or
• patients with any implantable electronic device (e.g. pacemaker) or internal metal material preventing BIA phase angle assessment

Sponsors & Collaborators

• University of Lisbon: lead

Study Sites (1)

Hospital de Santa Maria

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Paula Ravasco, MD PhD

CONTACT

p.ravasco@medicina.ulisboa.pt

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 11, 2015
• Study Start: March 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

PT (1)