Health TrialsbyHealthPanel

Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-70
SponsorUniversity of Belgrade

About this trial

This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 45 to 70 years

Postmenopausal women

Histologically confirmed BRC, stage I to IIIa

ER positive /HER2 negative

Disqualifiers

Metastatic or locally advanced disease

HER2-positive tumors

Presence of other malignant or serious chronic diseases

Active infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supplement

    Dietary supplement

    Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid

  • AI diet

    Dietary supplement

    diet rich in whole grains, healthy oils and polyphenols,

  • Placebo

    Dietary supplement

    Placebo caps with standard diet

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: AI DietExperimental treatment 1 intervention
Group B: SupplementsActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Nutritional status

assessed through blood cells count

Time frame
baseline, 4 months, 1 year
2

Nutritional status

assessed through body mass index-BMI

Time frame
baseline, 4 months, 1 year
3

Nutritional status

assessed through body composition- lean tissue, fat tissue and body water (in kg)

Time frame
baseline, 4 months, 1 year
4

Changes in Quality of life

assessed through the questionnaires FACT ES. The response scale is 5 point Likert-type scale (0- not at all, 4- very much).

Time frame
baseline, 4 months

Secondary outcomes

1

Inflammatory status

levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α

Time frame
baseline, 4 months,
2

Redox status

total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L

Time frame
baseline, 4 months,
3

Redox status

superoxide dismutase (SOD)

Time frame
baseline, 4 months,
4

Redox status

thiobarbituric acid reactive substances (TBARS)

Time frame
baseline, 4 months,

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Belgrade

Lead sponsor

Source ClinicalTrials.gov
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