NCT01495650

Brief Summary

Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

3.5 years

First QC Date

December 15, 2011

Last Update Submit

August 16, 2017

Conditions

Breast Cancer

Keywords

Comprehensive Adjuvant CareCancer-related fatigueTherapeutic patient educationPhysical ActivityNutritional counsellingRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Subjective fatigue

    Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire

    At 18 months

Secondary Outcomes (7)

  • Quality of life

    At 18 months

  • Anxiety/depressive symptoms

    At 18 months

  • Physical activity level

    At 18 months

  • Muscular fatigue

    At 18 months

  • Attention fatigue

    At 18 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL
Behavioral: Tailored program of PA and nutritional counseling

Control arm

NO INTERVENTION

Routine practice

Interventions

Tailored program of PA and nutritional counselingBEHAVIORAL

Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).

Intervention arm

Eligibility Criteria

Age18 Years - 76 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patient with histologically proven breast cancer
  • years old
  • Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + taxanes) followed by radiotherapy
  • Satisfactory healing of breast and lymph nodes area
  • Ability to understand the nature, goal and study methodology
  • Consent to cooperate for clinical assessments
  • Affiliation to a social security regime or beneficiary of equivalent social protection
  • Written informed consent provided before any study specific procedures

You may not qualify if:

  • HER2 positive or metastatic cancer
  • Any other primary tumor
  • Contraindication to moderate physical activity
  • Contraindication to adjuvant chemotherapy or radiotherapy
  • Pregnancy or breast feeding
  • Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRLC Val d'Aurelle-Paul Lamarque

Montpellier, 34298, France

Location

Related Publications (2)

  • Touraine C, Jacot W, Gourgou S, Carayol M, Senesse P, Ninot G, Mollevi C. Impact of adapted physical activity and diet counselling on health-related quality of life in women undergoing adjuvant breast cancer therapy. Sci Rep. 2025 Mar 10;15(1):8215. doi: 10.1038/s41598-025-91569-w.

    PMID: 40064980DERIVED

  • Carayol M, Ninot G, Senesse P, Bleuse JP, Gourgou S, Sancho-Garnier H, Sari C, Romieu I, Romieu G, Jacot W. Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. BMC Cancer. 2019 Jul 25;19(1):737. doi: 10.1186/s12885-019-5896-6.

    PMID: 31345179DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 20, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

FR(1)