Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer — ATHENA  

Toxicity Due to Radiotherapy Clinical Trial

Official title: Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer

Status Completed

Clinical Trial Summary

Attention has been focused recently on the development of modalities that can protect healthy organs from the harmful effects of radiation applied during different cancer treatment schedules. As radiation-induced DNA damage involves oxidative stress, the protective role of antioxidants has been tested in different dietary studies. Previous experience by the collaborative team of the principal investigator and radiotherapists at the Catholic University of Campobasso has shown in a retrospective study that moderate wine consumption can reduce the side-effects of radiation therapy in patients with breast cancer. This effect was presumably due to the polyphenol non alcoholic fraction of wine, a finding in agreement with a cross-over intervention study in adult male volunteers, on protection by de-alcoholized red wine from ex vivo radiation-induced DNA damage.

The purpose of this clinical trial will be to test the impact of supplementation with anthocyanin-enriched food on the acute and medium-term side effects of radiotherapy in breast cancer patients, in a prospective study design. Therefore a double blind, randomised, placebo-controlled clinical trial will be organised by assigning patients with breast cancer scheduled for radiotherapy to a diet supplemented with an anthocyanin soluble extract.

Clinical Trial Description

Detailed Description

1. Study Rationale:

Attention has been focused recently on the development of modalities that can protect healthy organs from the harmful effects of radiation applied during different cancer treatment schedules. As radiation-induced DNA and cellular damage involve oxidative stress, the protective role of antioxidants will be tested on the toxic condition induced by radiotherapy in breast cancer treatment. Consumption of polyphenol-rich foods, such as fruits and vegetables, and beverages derived from plants, such as cocoa, red wine and tea, may represent a beneficial diet in terms of oxidative protection. Indeed, a retrospective study reports that that moderate wine consumption can reduce the side-effects of radiation therapy in patients with breast cancer. This effect was presumably due to the polyphenol non alcoholic fraction of wine, a finding in agreement with a cross-over intervention study in adult male volunteers, on protection by de-alcoholized red wine from ex vivo radiation-induced DNA damage. However, there are no studies that address the relationship of polyphenol-rich food consumption with the toxic effects of radiations in patients undergoing radiotherapy for breast cancer treatment.

2. Aim of the study. The main objectives of this study are to evaluate the association between the effect of polyphenol-rich food supplementation and toxicity of radiotherapy for breast cancer.

3. Study design: Randomized, placebo-controlled double-blind trial with 2 parallel arms:

soluble corn flour at high content in anthocyanins and placebo. Placebo consists of soluble corn flour poor in anthocyanins. The treatment will start one week before starting radiotherapy, and continue during all radiotherapy treatment (of 3 or 5 weeks).

4. Study Population and recruitment: A total of 300 consecutive breast cancer patients eligible for radiotherapy. Participants will be identified at the Department of Radiotherapy of the Giovanni Paolo II Foundation of Campobasso.

Eligible subjects will be recruited at their first consultation and subsequently referred to the research investigators. The research staff in charge of the recruitment will pre-screen participants on the basis of inclusion/exclusion criteria and will explain the study at this time. ;

Related Conditions & MeSH terms

• Toxicity Due to Radiotherapy

• NCT number: NCT02195960
• Study type: Interventional
• Source: Neuromed IRCCS
• Status: Completed
• Phase: N/A
• Start date: June 9, 2014
• Completion date: October 10, 2018