Breast CancerPhase 3APADNCT01495650
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
A Phase 3 study testing Tailored program of PA and nutritional counseling in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tailored program of PA and nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient with histologically proven breast cancer
- 18-76 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Tailored program of PA and nutritional counseling
- Keywords
- Comprehensive Adjuvant Care, Cancer-related fatigue, Therapeutic patient education, Physical Activity, Nutritional counselling, Rehabilitation
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored program of PA and nutritional counselingBehavioural
Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Behavioral: Tailored program of PA and nutritional counseling |
| Control arm | No intervention | Routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective fatigue
Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
Measured: At 18 months
Secondary outcomes (7)
Quality of life
Quality of life is measured by the EORTC QLC-C30 questionnaire
Measured: At 18 months
Anxiety/depressive symptoms
Anxiety/depressive symptoms is measured by the HADS questionnaire
Measured: At 18 months
Physical activity level
Physical activity level is measured by the GPAQ questionnaire
Measured: At 18 months
Muscular fatigue
Muscular fatigue is measured by Myotest
Measured: At 18 months
Attention fatigue
Attention fatigue is measured usingt the TAP 2.2 software
Measured: At 18 months
Body Mass Index
Body Mass Index is calculated using bodyweight and length measurements
Measured: At 18 months
Body composition
Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)
Measured: At 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495650
- Sponsor's protocol ID
- APAD
- Other IDs
- 2010-A00906-33
- Acronym
- APAD
- Status last verified
- Aug 2017
- First submitted
- 15 Dec 2011
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40064980Carayol 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.
PubMed 31345179
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.
- ClinicalTrials.gov ID
- NCT01495650
- Acronym / sponsor ID
- APAD / APAD
- Conditions
- Breast Cancer
- Keywords
- Comprehensive Adjuvant Care, Cancer-related fatigue, Therapeutic patient education, Physical Activity, Nutritional counselling, Rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Tailored program of PA and nutritional counseling |
| Control arm | No intervention | –Routine practice |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patient with histologically proven breast cancer
- 18-76 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
Key exclusion criteria (6 listed)
- HER2 positive or metastatic cancer
- Any other primary tumor
- Contraindication to moderate physical activity
- Contraindication to adjuvant chemotherapy or radiotherapy
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored program of PA and nutritional counselingPatients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks). | Behavioural | Intervention arm |
Primary outcome
Subjective fatigue
Time frame: At 18 months
Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
7 secondary outcomes
Quality of life
Time frame: At 18 months
Anxiety/depressive symptoms
Time frame: At 18 months
Physical activity level
Time frame: At 18 months
Muscular fatigue
Time frame: At 18 months
Attention fatigue
Time frame: At 18 months
Body Mass Index
Time frame: At 18 months
Body composition
Time frame: At 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 40064980Touraine 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.
- Derived from this study: PubMed 31345179Carayol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tailored program of PA and nutritional counseling in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective fatigue (time frame: At 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01495650, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.