Condition category
Cancer
Date applied
29/09/2015
Date assigned
16/10/2015
Last edited
29/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Being overweight or obese puts you at a higher risk for health problems such as heart disease, stroke, high blood pressure and diabetes, and is also associated with an increased risk of developing many forms of cancer, including breast cancer. There is also evidence that being overweight increases the risk of recurrence and death in patients diagnosed with breast cancer. We think that diet and/or exercise counseling could help overweight or obese breast cancer patients to lose weight, which could in turn improve their quality of life and general health status, and in the long term reduce the risk of breast cancer recurrence. We aim to find out about the effects of 6 months of counseling focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. The counseling is designed to promote a healthy diet or/and to increase exercise and decrease sedentary (sitting) time.

Who can participate?
Breast cancer patients aged 18 or older who are overweight or obese.

What does the study involve?
Participant are randomly allocated to one of four groups: diet counseling, exercise counseling, both diet and exercise counseling, or minimal counseling. Women allocated to the diet and/or exercise counseling groups are offered individual counseling consisting of face-to face contact, group meetings, motivational phone calls and information pamphlets. Participants are given a pedometer device (wrist band) in order to monitor their physical activity and sedentary time. Diet, quality of life, health status and participants' anxiety are assessed with questionnaires. Blood samples are collected at the start of the study and follow-up visits.

What are the possible benefits and risks of participating?
The expected result is weight loss in any of the diet or physical activity groups. Other expected long-term results include long-term weight control, increased physical fitness, increased physical activity, reduced sedentary time, healthier diet, improved health status and quality of life. We do not foresee any serious side effects. However, if participants will experience side effects, this will be reported immediately to the attention of the clinical staff. All participants will be monitored to prevent any possible deficiency or inadequate nutrient and/or calorie intake by evaluating their dietary intake. Participants will also be monitored for injuries or problems associated with the increased physical activity.

Where is the study run from?
European Institute of Oncology (IEO), Milan, Italy

When is the study starting and how long is it expected to run for?
March 2014 to December 2018

Who is funding the study?
The Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)

Who is the main contact?
1. Patrick Maisonnevue (public)
2. Patrizia Gnagnarella (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Patrizia Gnagnarella

ORCID ID

http://orcid.org/0000-0002-0560-4706

Contact details

European Institute of Oncology
Division of Epidemiology and Biostatistics
Via Adamello
6
Milan
20139
Italy

Type

Scientific

Additional contact

Dr Patrick Maisonneuve

ORCID ID

Contact details

European Institute of Oncology
Division of Epidemiology and Biostatistics
Via Adamello
6
Milan
20139
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IEO-0244

Study information

Scientific title

Promoting weight loss through diet and exercise in overweight women with breast cancer: a four-arm randomized trial - InForma study

Acronym

InForma

Study hypothesis

We hypothesized that individual dietary and/or exercise counseling could help overweight or obese breast cancer patients to lose weight, which could in turn improve their hormonal status, quality of life and general health status, and at long term limit their risk of developing breast cancer recurrence.

Ethics approval

Ethical Committee of the European Institute of Oncology, 01/04/2015 , ref: n. R233/15 –IEO 244

Study design

Mono-institutional randomized controlled four-arm parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Overweight or obese breast cancer patients

Intervention

We will randomize overweight or obese patients into four intervention arms:
1. Dietary Intervention (DI)
2. Physical Activity Intervention (PAI)
3. Physical Activity And Dietary Intervention (PADI)
4. Less Intensive Intervention (LII)

Women allocated to the dietary intervention and/or physical activity intervention arms will be offered an individualized dietary and/or physical activity counseling consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets. All participants will be given a pedometer device (wrist band) in order to monitor (in the two physical activity arms) participants’ physical activity and sedentary time. Dietary intake for all participants will be repeatedly assessed with validated food frequency questionnaires. Quality of life, health status and participants' anxiety will be assessed with self-administered questionnaires including FACT-B and the State-Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected at baseline and follow-up visit to assess glucose, insulin, lipid and hormone profile. Women allocated to the less intensive intervention (or minimal counseling) arm will be considered as control group.

Participants will be followed up for a further 18 months and outcome assessments will be made at 12 and 24 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in body weight (weight loss ≥5% of the baseline body weight) at the end of the 6-month intervention

Secondary outcome measures

The secondary outcome measures will be assessed along intervention including:
1. Maintain long-term weight control, measured at baseline, 6 months, 12 months and 24 months
2. Increase physical activity levels and reduce physical inactivity from baseline, measured at baseline, 6 months, 12 months and 24 months
3. Change in dietary intake (increase adherence to healthy diet from baseline), measured at baseline, 6 months and 24 months
4. Evaluate the effect of intervention on long-term breast cancer recurrence
5. Change in health status and quality of life, measured at baseline, 6 months, 12 months and 24 months
6. Evaluate the effect of intervention on blood lipid profile (total cholesterol, LDL and HDL cholesterol, triglycerides), measured at baseline, 6 months and 24 months
7. Evaluate the effect of intervention on biomarkers (estradiol, C-reactive protein (CRP), insulin, glucose), measured at baseline, 6 months and 24 months

Overall trial start date

01/03/2014

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 18 or older
2. Written informed consent obtained
3. Willing to be randomized to either group
4. Histological breast cancer diagnosis
5. BMI comprised between 25 and 40 kg/m2
6. Within one year/6 months of completion of main cancer treatment
7. Willing to wear the wrist-based activity monitor during the 6-month study period

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

260

Participant exclusion criteria

1. Unable to find transportation to the study location over the study period
2. Plan to move away from Lombardy or to be out of town for more than 3 weeks during the study period
3. Investigator does not approve participation in the study in case of:
3.1. History of heart condition, stroke, chest pain during activity or rest
3.2. Severe hypertension
3.3. Patient is unable to walk for exercise (self-report)
3.4. Symptoms of alcohol or substance dependence
3.5. Recent hip fracture, hip or knee replacement, spinal surgery or other orthopedic complications that would prevent optimal participation in the physical activities prescribed
4. Any other severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period
5. Participant already participates to a physical activity or diet intervention trial
6. Participant currently uses an activity monitor device

Recruitment start date

01/10/2015

Recruitment end date

01/10/2016

Locations

Countries of recruitment

Italy

Trial participating centre

European Institute of Oncology
Via Ripamonti, 435
Milan
20141
Italy

Sponsor information

Organisation

European Institute of Oncology (Italy)

Sponsor details

Via Ripamonti
435
Milan
20141
Italy

Sponsor type

Research organisation

Website

http://www.ieo.it/

Funders

Funder type

Research organisation

Funder name

Associazione Italiana per la Ricerca sul Cancro

Alternative name(s)

Italian Association for Cancer Research, AIRC

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Italy

Results and Publications

Publication and dissemination plan

1. Protocol publication in a international peer-reviewed journal
2. The results will be presented in national and international scientific meetings
2. Publication in national journals and international peer-reviewed journals

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27464488

Publication citations

Additional files

Editorial Notes

29/07/2016: Publication reference added.