Breast CancerNCT04980118
A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.
A study testing Nutrition and physical activity group in people with Breast Cancer and Body Weight Changes, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Body Weight Changes, Weight Loss
- What is being tested?
- Nutrition and physical activity group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Years: ≥18
- Sex: Female
- Newly diagnosed breast cáncer
Who cannot join
- Patients who have disseminated disease.
- Associated eating behavior disorders.
- Patients with dementia, mental illness or decreased cognitive function.
- Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study).
- Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Standardized Integral Nutritional Intervention 1 and Physical Activity Program
To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.
Read the detailed description
56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain.
A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.
- Being tested
- Control group, Nutrition and physical activity group
- Medical subject headings
- Breast Neoplasms, Body Weight Changes, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
A nutritional intervention program that consisted of two individual nutritional consults.
Nutrition and physical activity groupBehavioural
A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Individual nutritional intervention. Receives: Behavioral: Control group |
| Experimental group | Experimental | Individual nutritional intervention with two groupal sessions and physical activity. Receives: Behavioral: Nutrition and physical activity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.
To examine the frequency of food consumption
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study startApr 2010
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, Msc, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980118
- Sponsor's protocol ID
- HULP 3114
- Status last verified
- Aug 2019
- First submitted
- 12 Sep 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Integral Nutritional Intervention 1 and Physical Activity Program
- ClinicalTrials.gov ID
- NCT04980118
- Acronym / sponsor ID
- HULP 3114
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.
Detailed description
56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain.
A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: Control groupIndividual nutritional intervention. |
| Experimental group | Experimental | Behavioral: Nutrition and physical activity groupIndividual nutritional intervention with two groupal sessions and physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Years: ≥18
- Sex: Female
- Newly diagnosed breast cáncer
Key exclusion criteria (6 listed)
- Patients who have disseminated disease.
- Associated eating behavior disorders.
- Patients with dementia, mental illness or decreased cognitive function.
- Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study).
- Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupA nutritional intervention program that consisted of two individual nutritional consults. | Behavioural | Control group |
| Nutrition and physical activity groupA nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures. | Behavioural | Experimental group |
Primary outcome
To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.
Time frame: Six months
To examine the frequency of food consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, Msc principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and physical activity group in people with Breast Cancer and Body Weight Changes, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021; AzTrials last refreshed its copy on 1 Nov 2026.