Condition category
Cancer
Date applied
13/05/2019
Date assigned
20/05/2019
Last edited
20/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims.
Cancer is one of the leading causes of morbidity and mortality in our society, being responsible for nearly one-sixth of deaths and is expected to rise by about 70% over the next two decades. In the last years, many epidemiological studies related to the assessment of the relationship between nutrition and cancer have been done. However, studies which focus on the role of nutrition for the oncological patient are less frequent. It is commonly agreed that a poor nutritional status during cancer treatment weakens the patient, renders the administration of an appropriated treatment difficult, and increases treatment side-effects. There are several guidelines providing nutritional recommendations for cancer patients during the disease, mainly addressed to minimize treatment side effects. Despite the increasing demand for specific nutritional recommendations during the disease, tools for personalized nutritional indications and nutrition support are not yet used routinely as an adjunct to treatments.

In a previous study, we found that cancer patients had an altered lipid metabolism compared to a healthy population. The objective of this study is to evaluate if personalised nutritional advice based on the measure of the lipid metabolism of each the patient can provide an improvement for the nutritional and metabolic status of the patients during the chemotherapy treatment. The lipid profile will be measured by the lipid analysis of the red blood cell membranes. Patients in the diet group will receive personalised advice for diet and fatty acid supplements. At the end of the chemotherapy (6 months), the lipid profile will be measured again, together with the quality of life and other clinical parameters to assess the effect of the personalised diet.

Who can participate?
Cancer patients who initiate a chemotherapy treatment with a life expectancy of at least 1 year, age less than 70 years and a body mass index (BMI) less than 35.

What does the study involve?
Patient participation in this study involves:
To complete a questionnaire that collects information regarding eating habits, taste and smell alterations, food preferences and quality of life, through personal interviews taking advantage of visits to the Outpatient Unit of Onkologikoa hospital. This questionnaire will be completed three times throughout the chemotherapy treatment (time 0, 3 months and 6 months)
Blood extraction for lipid analysis and biochemical parameters (2 tubes of 3 mL) twice throughout the study (time 0 and 6 months)
To follow the nutritional recommendations defined according to your individual needs

What are the possible benefits and risks of participating?
We consider that this clinical trial has low risk, new experimental drugs are not being used. We will work with nutritional supplements of fatty acids, currently available on the market, of proven quality, previously used in clinical trials and in safe doses (not exceeding those recommended by the European Food Safety Agency (EFSA)).

In addition, the nutritional recommendations that will be provided, are based on the Mediterranean diet, a balanced diet and with a scientific basis for its benefit in the prevention of chronic diseases such as cardiovascular diseases and cancer.

Likewise, this study will contribute to generate knowledge and discover new nutritional strategies for cancer patients during chemotherapy treatment.

Where is the study run from?
Onkologikoa Foundation, Located in San Sebastian, Basque Country-Spain.

When is the study starting and how long is it expected to run for?
The trial started on 26/06/2017, and it is expected to end on 04/10/2019

Who is funding the study?
This work was funded by AZTI and Onkologikoa Foundation.

Who is the main contact?
Dr. Itziar Tueros
itueros@azti.es

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Dr Itziar Tueros

ORCID ID

http://orcid.org/0000-0002-7609-5435

Contact details

Parque Tecnológico de Bizkaia. Astondo Bidea 609
Derio-Basque Country
48160
Spain
946574000
itueros@azti.es

Type

Scientific

Additional contact

Dr Itziar Tueros

ORCID ID

http://orcid.org/0000-0002-7609-5435

Contact details

Parque Tecnológico de Bizkaia. Astondo Bidea 609
Derio-Basque Country
48160
Spain
946574000
itueros@azti.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Personalized nutrition for cancer patients in chemotherapy treatment according to erythrocyte membrane lipid profile.

Acronym

CALIMA

Study hypothesis

This project is based on the hypothesis that mature erythrocytes are indicators of altered lipid metabolism in cancer patients and through a personalized nutritional plan (nutrition advice + supplementation) it is possible to recover the balance of the lipid profile at the cellular level of cancer patients.

Ethics approval

Approved 04/12/2016, the Ethics Committee of Clinical Research of the Health Area of Gipuzkoa (Pº Doctor Beguiristains. 20014. San Sebastian-Spain; ceic.eeaa@euskadi.eus; +34 945 01 92 96; +34 945 01 56 34), ref: 1090/2015.

Study design

Single centre, prospective randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Cancer

Intervention

A prospective controlled clinical trial with intervention in the diet for six months in cancer patients from the Onkologikoa Foundation (single-centre) will be conducted. After diagnosis and prior to chemotherapy treatment, participants will be recruited and randomly assigned to two groups: diet and control. Patients will be randomized (following a table of random numbers generated by a computer) considering age, BMI and molecular characteristics of the tumor [expression of human epidermal growth factor 2 (HER2)] in a 1: 1 ratio to each of the two groups.

The lipid profile in the erythrocyte membrane will be analyzed for all participants. Data regarding dietary habits, quality of life and clinical data will be also collected. Patients in the diet group will receive personalized nutrition advice and fatty acid food supplements, based on their erythrocyte lipid profile for the next six months. Food supplements will come from Lipinutragen brand because of their already tested good quality. These supplements contain long chain fatty acids (EPA, DHA), gamma-linolenic acid and alfa-linolenic acid in doses recommended by EFSA. The diet will be based on Mediterranean diet guidelines and adjusted for different fat families. The control group will not receive any personalized advice, they will follow the general recommendations according to the Mediterranean diet.

At the end of the treatment, the lipid profile will be measured again. Both groups will be compared to evaluate the effectiveness of the nutritional treatment (personalized advice + supplementation) to recover the balance in the erythrocyte lipid profile in six months. Other biochemical parameters related to lipid metabolism and inflammation, as well as the quality of life of patients, will be also evaluated.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

The lipid profile of the erythrocyte membrane is measured using GC-MS (Gas Chromatography Mass Spectrometry) in blood simples (1 ml) at baseline and the end of chemotherapy.

Secondary outcome measures

1. Quality of life is measured using validated EORTC questionnaires (QLQ-C30) and a specific module for different types of cancer (QLQ-BR23, QLQ-CR29, QLQ-OV28 and QLQ-PR25) at an intermediate point of the intervention treatment and at the end of the chemotherapy treatment.
2. Sensory alterations in taste, smell and appetite, and food preferences are measured using a questionnaire (defined in Amézaga J., et al., 2018) at baseline, at an intermediate point of the intervention treatment and at end of the chemotherapy treatment.
3. Nutritional habits are measured using a food frequency questionnaire (validated for the Spanish population in the PREDIMED study - Fernandez-Ballart, J.D., et al., 2010) at baseline and at the end of the chemotherapy treatment.

Overall trial start date

01/03/2017

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients of any type of Cancer who initiate a chemotherapy treatment, and who understand their participation in the trial.
2. Neoadjuvant, adjuvant and metastatic treatments will be considered.
3. A life expectancy of at least 1 year.
4. Age less than 70 years.
5. A body mass index (BMI) less than 35.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total sample of 52 cancer patients, with randomization in two groups of equal size (an intervention group N = 26 and a control group N = 26), we get a statistical power of 85% with a 95% confidence level.

Participant exclusion criteria

1. Diabetic or with other risk factors related to lipid metabolism such as metabolic syndrome.
2. Allergy to fish.
3. Severe malnutrition, cachexia or anorexia.

Recruitment start date

28/06/2017

Recruitment end date

30/09/2019

Locations

Countries of recruitment

Spain

Trial participating centre

Onkologikoa Foundation.
P. Dr Beguiristain 121.
San Sebastian
20014
Spain

Sponsor information

Organisation

AZTI

Sponsor details

Bizkaia Technology Park
Astondo Street
Building 609.
Derio (Vizcaya)
48160
Spain
946574000
info@azti.es

Sponsor type

Research organisation

Website

https://www.azti.es/es/

Organisation

Onkologikoa Foundation

Sponsor details

Located in the Hospital Zone of Miramon
Paseo Doctor Begiristain
121.
San Sebastian (Basque Country-Spain).
20014
Spain
943328000
info@onkologikoa.org

Sponsor type

Hospital/treatment centre

Website

https://www.onkologikoa.org/es/

Funders

Funder type

Research organisation

Funder name

AZTI

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Onkologikoa Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be published in high impact scientific journals and in national and international congress on cancer, nutrition, metabolism and medical topics, in 2020:
1. Appetite: behavioral sciences; nutrition & dietetics
2. Progress in lipid research: biochemistry & molecular biology; nutrition & dietetics
3. Lipids in health and disease: biochemistry & molecular biology; nutrition & dietetics
4. Nutrients: nutrition & dietetics
5. European journal of clinical nutrition: nutrition & dietetics
6. Supportive care in cancer: oncology; health care sciences & services
7. Cancer treatment reviews: oncology

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/05/2019: Trial's existence confirmed by the Ethics Committee of Clinical Research of the Health Area of Gipuzkoa.