- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01563588
Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy
Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.
The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Puy de Dome
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Clermont-Ferrand, Puy de Dome, Frankrig, 63011
- Centre Jean Perrin
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Clermont-Ferrand, Puy de Dome, Frankrig, 63100
- Pole Santé-République
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- breast cancer
- treatment including a chemotherapy
- in complete remission
- last treatment in the last 9 months before inclusion
- signed consent
Exclusion Criteria:
- metastatic disease
- relapse
- women enable to have physical activity
- heart disease or any pathology preventing physical activity
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: dietary and physical training
12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
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12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
|
Ingen indgriben: control
dietary counseling by a dietetician in the anticancer hospital
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of life (SF36)
Tidsramme: one year after inclusion
|
Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months.
The difference at one year was the main endpoint.
|
one year after inclusion
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Anxiety/depression scores (HAD)
Tidsramme: inclusion, 6, 12, 18, 24, 36 months
|
HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.
|
inclusion, 6, 12, 18, 24, 36 months
|
Weight and morphometric measures
Tidsramme: inclusion, 6, 12, 18, 24, 36 months
|
Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups
|
inclusion, 6, 12, 18, 24, 36 months
|
Sleep quality
Tidsramme: inclusion, 6, 12, 18, 24, 36 months
|
6 questions are asked: it rates the delay before sleep onset, the lenght of sleep, the number of awakening, the lenght of wake periods during the night, the concentration/alertness after sleep, and the fatigue in the morning.
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inclusion, 6, 12, 18, 24, 36 months
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economic figures
Tidsramme: during 2 years after inclusion
|
health related costs, health insurance costs, social costs
|
during 2 years after inclusion
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PACThe
- 2008-A 01606 - 49 (Registry Identifier: AFSSAPS (France))
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