Non Metastatic Breast Cancer Clinical Trial
Official title:
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.
| Status | Terminated |
| Enrollment | 251 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Jean Perrin | Clermont-Ferrand | Puy de Dome |
| France | Pole Santé-République | Clermont-Ferrand | Puy de Dome |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Jean Perrin |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of life (SF36) | 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 | No |
| Secondary | Anxiety/depression scores (HAD) | HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire. | inclusion, 6, 12, 18, 24, 36 months | No |
| Secondary | Weight and morphometric measures | Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups | inclusion, 6, 12, 18, 24, 36 months | No |
| Secondary | Sleep quality | 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. | inclusion, 6, 12, 18, 24, 36 months | No |
| Secondary | economic figures | health related costs, health insurance costs, social costs | during 2 years after inclusion | No |
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