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Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial.

BMC cancer
January 1, 1970
Marion Carayol et al. (10 authors)
Clinical Trial, Phase IIIJournal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effects of a combined diet and exercise intervention (APAD) on fatigue, quality of life, and other outcomes in early breast cancer patients undergoing chemotherapy and radiotherapy.

Results Summary

The APAD intervention significantly improved fatigue, quality of life, anxiety, and depression at 18 and 26 weeks, with benefits on fatigue and QoL persisting up to 12 months. It also reduced BMI and fat mass while enhancing muscle endurance and cognitive flexibility at 26 weeks, though these effects did not persist long-term.

Population

Women diagnosed with early breast cancer (N=143, mean age=52±10 years).

Effective Dosage

9 dietetic consultations (frequency not specified) combined with thrice-weekly moderate-intensity exercise sessions.

Duration

26 weeks (end of radiotherapy and intervention), with follow-ups at 6 and 12 months post-intervention.

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Adapted Physical Activity and Diet (APAD) intervention
decrease
all patient-reported outcomes (i.e., fatigue, QoL, anxiety, depression)
Women diagnosed with early breast cancer
-
Significant beneficial effects
#1
Adapted Physical Activity and Diet (APAD) intervention
decrease
fatigue
Women diagnosed with early breast cancer
-
significant effect persisted
#2
Adapted Physical Activity and Diet (APAD) intervention
increase
QoL
Women diagnosed with early breast cancer
-
significant effect persisted
#3
Adapted Physical Activity and Diet (APAD) intervention
decrease
BMI
Women diagnosed with early breast cancer
-
Significant decreases
#4
Adapted Physical Activity and Diet (APAD) intervention
decrease
fat mass
Women diagnosed with early breast cancer
-
Significant decreases
#5
Adapted Physical Activity and Diet (APAD) intervention
increase
muscle endurance
Women diagnosed with early breast cancer
-
increased
#6
Adapted Physical Activity and Diet (APAD) intervention
increase
cognitive flexibility
Women diagnosed with early breast cancer
-
increased
#7
Adapted Physical Activity and Diet (APAD) intervention
increase
Leisure physical activity
Women diagnosed with early breast cancer
-
enhanced
#8
Adapted Physical Activity and Diet (APAD) intervention
no change
major macronutrients intake
Women diagnosed with early breast cancer
-
No significant effect
#9
Abstract

BACKGROUND: Patients with breast cancer undergoing chemotherapy and radiotherapy experience fatigue and other treatment side effects. Integrative therapies combining physical activity and dietary counseling are recommended; however to date no large randomized controlled trial has been conducted during adjuvant therapy. The Adapted Physical Activity and Diet (APAD) intervention was evaluated for its ability to decrease fatigue (primary outcome), anxiety, depression, body mass index (BMI), and fat mass, and enhance muscular and cognitive performances, and quality-of-life (QoL). METHODS: Women diagnosed with early breast cancer (N = 143, mean age = 52 ± 10 years) were randomized to APAD or usual care (UC). APAD included thrice-weekly moderate-intensity mixed aerobic and resistance exercise sessions and 9 dietetic consultations. Patient-reported outcomes (PROs) and anthropometric, muscular, and cognitive variables were measured at baseline, 18 weeks (end of chemotherapy), and 26 weeks (end of radiotherapy and intervention), and at 6- and 12-month post-intervention follow-ups. Multi-adjusted linear mixed-effects models were used to compare groups over time. RESULTS: Significant beneficial effects of the APAD intervention were observed on all PROs (i.e., fatigue, QoL, anxiety, depression) at 18 and 26 weeks. The significant effect on fatigue and QoL persisted up to 12-month follow-up. Significant decreases in BMI, fat mass, and increased muscle endurance and cognitive flexibility were observed at 26 weeks, but did not persist afterward. Leisure physical activity was enhanced in the APAD group vs UC group at 18 and 26 weeks. No significant effect of the intervention was found on major macronutrients intake. CONCLUSIONS: A combined diet and exercise intervention during chemotherapy and radiotherapy in patients with early breast cancer led to positive changes in a range of psychological, physiological and behavioral outcomes at the end of intervention. A beneficial effect persisted on fatigue and QoL at long term, i.e., 1 year post-intervention. Diet-exercise supportive care should be integrated into the management of early breast cancer patients. TRIAL REGISTRATION: The APAD study was prospectively registered on ClinicalTrials.gov (NCT01495650; date of registration: December 20, 2011).

Medical Subject Headings (MeSH)
AdolescentAdultAgedAnxietyBreast NeoplasmsChemoradiotherapy, AdjuvantCombined Modality TherapyCounselingDepressionExercise TherapyFatigueFemaleHumansMastectomyMiddle AgedNutrition TherapyPatient Reported Outcome MeasuresProspective StudiesQuality of LifeTreatment OutcomeYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality90/10
Citation Metrics
Total Citations86
Citations/Year14.3
Relative Citation Ratio4.86
NIH Percentile92.7%
Research Impact Scores
APT Score0.95
Weight Score2.08
Normalized Score0.72
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