NCT05656716

Brief Summary

The main aim of this study is to determine the effect of a multimodal intervention (Nutrition and Exercise) on quality of life, emotional well-being, and secondary symptomatology in patients diagnosed with breast cancer during neoadjuvant chemotherapy treatment, and to compare them with the control group.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

November 27, 2022

Last Update Submit

May 7, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

  • Participant's quality of life

    QLQ-CD30 test

    6 months

  • Participant's quality of life

    BR23 test

    6 months

  • Body composition

    Weight (kg)

    6 months

  • Body composition

    Height (cm)

    6 months

  • Body composition

    Circumferences (waist and hip; cm)

    6 months

  • Body composition

    Fat mass (kg), visceral fat (g), lean mass (kg) and bone mineral content (g) will be evaluated by Dual Energy X-Ray Absorptiometry (Discovery Wi, Hologic Bedford, MA, USA) and 18F-FDG PET/CT

    6 months

Secondary Outcomes (8)

  • Response rate

    6 months

  • Analytical parameters

    6 months

  • Analytical parameters

    6 months

  • Analytical parameters

    6 months

  • Physical parameters

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants randomized to receive the multimodal intervention (nutrition and exercise)

Behavioral: Nutritional interventionBehavioral: Physical exercise intervention

Control group

NO INTERVENTION

Participants will not receive the multimodal intervention.

Interventions

Nutritional interventionBEHAVIORAL

The nutritional intervention will be based on a nutritional education program adapted for patients with breast cancer in active treatment. The nutritional intervention program will be based on the practical guidelines for nutrition in the oncology patient. The main objectives of the nutritional intervention will focus on preventing malnutrition, maintaining an adequate nutritional status and dietary adaptation to secondary symptomatology. To this end, an adequate energy and protein intake will be ensured and the consumption of plant-based foods will be promoted to ensure an adequate intake of vitamins, minerals and antioxidants

Intervention group
Physical exercise interventionBEHAVIORAL

Weekly physical exercise guidelines will be given following the published Canadian clinical guideline recommendations combining moderate and vigorous aerobic activity. Walking will be performed 3 days a week for 30 minutes at a modified Borg scale intensity of 4-5/10, and 2 days a week for 15 minutes at a modified Borg scale intensity of 7-8/10. There will also be 5 minutes of warm-up and 5 minutes of recovery, in moderate activity at 3/10, and in vigorous activity at 4/10. In addition, 3 days per week (not coinciding with vigorous aerobic activity) of strength training at a modified Borg scale intensity of 7/10 will be included. Two sets of 8-10 repetitions will be performed, adaptable to that intensity according to the progression of the subjec

Intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with breast cancer who will undergo neoadjuvant treatment in the Oncology Unit of the Virgen de las Nieves University Hospital of Granada.
  • Aged between 18 and 75 years.
  • Give their consent to participate in the study and commit to complete the entire intervention and attend their follow-up appointments.

You may not qualify if:

  • Patients who do not register the data required for follow-up.
  • Any condition that, in the investigator's opinion, impairs the ability to participate in the study or represents a personal risk for the participant.
  • Are deemed unsuitable by the investigator for any other reason, that prevent data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lucas J Jurado-Fasoli

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Jurado-Fasoli

CONTACT

618375662juradofasoli@ugr.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 27, 2022

First Posted

December 19, 2022

Study Start

January 15, 2023

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

ES(1)