NCT02195960: ATHENA

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

Completed NA Last updated 27 January 2021

What this trial tests

NA trial testing Placebo in Toxicity Due to Radiotherapy in 242 participants. Completed in 10 October 2018.

Timeline

9 June 2014

Primary endpoint
26 June 2017

10 October 2018

Quick facts

Lead sponsor	Neuromed IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	242
Start date	9 June 2014
Primary completion	26 June 2017
Estimated completion	10 October 2018
Sites	1 location across Italy

Drugs / interventions tested

• Placebo
• intake anthocyanin-rich corn extract

Conditions studied

• Toxicity Due to Radiotherapy — all drugs for Toxicity Due to Radiotherapy →

Sponsor

Neuromed IRCCS

Who can join

18 and older, female only, with Toxicity Due to Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of anthocyanins on the prevention and treatment of cancer.
   Lin BW, Gong CC, Song HF, Cui YY. · · 2017 · cited 219× · PMID 27646173 · DOI 10.1111/bph.13627
2. The Hallmarks of Flavonoids in Cancer.
   Ponte LGS, Pavan ICB, Mancini MCS, da Silva LGS, et al · · 2021 · cited 94× · PMID 33918290 · DOI 10.3390/molecules26072029
3. Dietary anthocyanins and health: data from FLORA and ATHENA EU projects.
   Cerletti C, De Curtis A, Bracone F, Digesù C, et al · · 2017 · cited 43× · PMID 27016122 · DOI 10.1111/bcp.12943
4. Machine-learning prediction model for acute skin toxicity after breast radiation therapy using spectrophotometry.
   Cilla S, Romano C, Macchia G, Boccardi M, et al · · 2022 · cited 13× · PMID 36686808 · DOI 10.3389/fonc.2022.1044358
5. A Critical Appraisal of the Protective Activity of Polyphenolic Antioxidants against Iatrogenic Effects of Anticancer Chemotherapeutics.
   Purgatorio R, Boccarelli A, Pisani L, de Candia M, et al · · 2024 · cited 9× · PMID 38275658 · DOI 10.3390/antiox13010133
6. Exploring the pharmacokinetics, drug-likeness, and toxicological features of anticancer flavonoids: a Boulevard to explore their clinical translational potential.
   Dubey AK, Chandragiri SS, Geevarghese AV, Kapoor B, et al · · 2025 · cited 2× · PMID 41111522 · DOI 10.3389/fphar.2025.1648395
7. Dietary Macronutrient Composition and Risk of Radiation-Induced Acute Skin Toxicity in Women with Breast Cancer: Results from the ATHENA Project.
   Sharma S, Bracone F, Di Castelnuovo A, Ruggiero E, et al · · 2024 · cited 1× · PMID 39796571 · DOI 10.3390/nu17010136
8. Plasma branched-chain amino acids and risk of radiation-induced acute skin toxicity in women with breast cancer: results from the ATHENA project.
   Sharma S, Bracone F, Di Castelnuovo A, Ruggiero E, et al · · 2025 · PMID 41189935 · DOI 10.3389/fonc.2025.1653293