Clinical trial · Interventional
Nutritional Intervention-induced Weight Loss During the Oncological Treatment of Obesity-related Breast Cancer
Evaluation of Changes in the Methylome and Prognosis of Obesity-related Breast Cancer After Nutritional Intervention-induced Weight Loss During the Oncological Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Obesity could become the first evitable cause of breast cancer in the near future. Due to the relatively slow rate of development in this field, greater efforts must be applied in this area. The HYPOTHESIS of this work is that "a therapy to lose weight in breast cancer women with obesity during the oncological treatment could contribute to slowing carcinogenesis, and to improve the response to the chemotherapy, survival and prevent future recurrences by erasing deleterious epigenetic marks". A group of breast cancer women with obesity (n=90) will be treated to lose weight during the oncologic treatment with a low calorie-ketogenic diet or a group educational intervention program of healthy lifestyle. The reversibility of the obesity-related breast cancer epigenetic signatures (EPIC array and pyrosequencing) and other molecular features (QRTPCR, ELISA assays) in blood leukocytes and plasma and the progression of disease will be compared with an obesity (n=30) and normalweight (n=30) group under conventional anticancer therapy. A matched-group of tumor-free women (n=60) with obesity will be also treated to lose weight with the same nutritional interventions and compared with tumor-free women with normal weight (n=30) in order to evaluate the potential preventive function of weight loss therapies on cancer-related odds. The outcomes of this project will directly benefit overweight and obese patients from healthcare systems, and also to have an economic value supporting pharmaceutical and food industry companies in the design of innovative treatments, useful biomarkers and preventive tools.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Epigenetic Disorder | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Weight Change, Body | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group educational intervention program (IGOBE) | Behavioral | — | UNRESOLVED |
| Very low calorie ketogenic diet (VLCKD) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Energy restriction-ketogenic intervention (VLCKD)-breast cancer arm
- description
- Breast cancer patients with obesity will follow an energy-restricted-ketogenic dietary five steps program, which includes lifestyle and behavioral modification support. The first three steps consist of a VLCKD (600 -800 kcal/day), low in carbohydrates (\< 50 g daily from vegetables) and lipids (only 10 g of olive oil per day). Throughout these ketogenic phases, supplements of vitamins and minerals supplements, such as K, Na, Mg, Ca, and omega-3 fatty acids will be administered. These three steps will be maintained until the patient lost the target amount of weight, ideally 80%. In steps 4 and 5, the patient started a low-calorie diet (800 -1500 kcal/day) and followed by a maintenance diet that will consist of an eating plan balanced in carbohydrates, protein, and fat (1500 and 2000 kcal/day).
- interventionNames
- Other: Very low calorie ketogenic diet (VLCKD)
- type
- EXPERIMENTAL
- label
- Group educational intervention program (IGOBE)-breast cancer arm
- description
- Breast cancer patients with obesity will follow structured program of change of habits that will consist of a balanced hypocaloric diet, following the criteria of both the recommendations from Spanish Society of Study of Obesity (SEEDO) 2007, the American Dietetic Guidelines 2010, the Consensus SEEDO 2012 and the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society Guideline for the Management of Overweight and Obesity in Adults 2014. Coinciding all in pointing out that the hypocaloric diet should represent a deficit of about 500 to 1000 kcal / day with respect to the habitual intake of the patient in question. The intervention group will be included in a structured program of habits change and exercise. In the intensive phase of the intervention patients will assist to 6 additional weekly visits, with 15 patients per group and a duration of 60 minutes each.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women * Primary, histologically confirmed, incident breast cancer diagnostic Exclusion Criteria: * Thyroid disorder, * Diabetes mellitus, * Cardiovascular disease, * cerebrovascular disease * Obesity induced by other endocrine disorders or drugs, * Participation in any active weight loss program in the previous 3 months. * Known or suspected narcotic or alcohol abuse, * Severe depression or any other psychiatric disease, * Severe liver failure * Uncontrolled hypertension, * Orthostatic hypotension, * hydroelectrolytic or electrocardiographic alterations * Prescription of drugs that may alter the lipid or glucose profile.
References
Publications (8)
- BACKGROUNDCabia B, Andrade S, Carreira MC, Casanueva FF, Crujeiras AB. A role for novel adipose tissue-secreted factors in obesity-related carcinogenesis. Obes Rev. 2016 Apr;17(4):361-76. doi: 10.1111/obr.12377. Epub 2016 Feb 24. PMID 26914773
- BACKGROUNDCrujeiras AB, Cabia B, Carreira MC, Amil M, Cueva J, Andrade S, Seoane LM, Pardo M, Sueiro A, Baltar J, Morais T, Monteiro MP, Lopez-Lopez R, Casanueva FF. Secreted factors derived from obese visceral adipose tissue regulate the expression of breast malignant transformation genes. Int J Obes (Lond). 2016 Mar;40(3):514-23. doi: 10.1038/ijo.2015.208. Epub 2015 Oct 26. PMID 26443342
- BACKGROUNDCrujeiras AB, Cueva J, Vieito M, Curiel T, Lopez-Lopez R, Pollan M, Casanueva FF. Association of breast cancer and obesity in a homogeneous population from Spain. J Endocrinol Invest. 2012 Jul;35(7):681-5. doi: 10.3275/8370. Epub 2012 Apr 18. PMID 22522745
- BACKGROUNDCrujeiras AB, Diaz-Lagares A, Carreira MC, Amil M, Casanueva FF. Oxidative stress associated to dysfunctional adipose tissue: a potential link between obesity, type 2 diabetes mellitus and breast cancer. Free Radic Res. 2013 Apr;47(4):243-56. doi: 10.3109/10715762.2013.772604. Epub 2013 Feb 26. PMID 23409968
- BACKGROUNDCrujeiras AB, Diaz-Lagares A, Sandoval J, Milagro FI, Navas-Carretero S, Carreira MC, Gomez A, Hervas D, Monteiro MP, Casanueva FF, Esteller M, Martinez JA. DNA methylation map in circulating leukocytes mirrors subcutaneous adipose tissue methylation pattern: a genome-wide analysis from non-obese and obese patients. Sci Rep. 2017 Feb 17;7:41903. doi: 10.1038/srep41903. PMID 28211912
- BACKGROUNDCrujeiras AB, Diaz-Lagares A, Stefansson OA, Macias-Gonzalez M, Sandoval J, Cueva J, Lopez-Lopez R, Moran S, Jonasson JG, Tryggvadottir L, Olafsdottir E, Tinahones FJ, Carreira MC, Casanueva FF, Esteller M. Obesity and menopause modify the epigenomic profile of breast cancer. Endocr Relat Cancer. 2017 Jul;24(7):351-363. doi: 10.1530/ERC-16-0565. Epub 2017 Apr 25.