Unresectable Locally Advanced CancerNCT02184663
Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer
A study testing without APA program and APA program in people with Unresectable Locally Advanced Cancer and Metastatic Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 17 sites in France.
Trial summary
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer. Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Locally Advanced Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- without APA program and APA program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 17 sitesFrance
- Study dates
- 20 Nov 2014to 30 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven non resectable pancreatic adenocarcinoma
- Indication of palliative chemotherapy
- Life expectancy ≥ 3 months
- Eastern Cooperative oncology group (ECOG) - Performance status ≤2
- Age ≥18 years old
- At least one measurable lesion as assessed by CT-scan or MRI (Magnetic resonance Imaging)
Show all 9Show fewer
- Identified Accompanying partner Adapted Physical Activity (AAPA)
- Signed and dated informed consent
- Registration in a National Health Care System (CMU included for France)
Who cannot join
- Previous Cerebrovascular accident or myocardial infarction <6months
- Uncontrolled hypertension.
- Severe cardiovascular or respiratory disease
- Severe cognitive or psychiatric disorder
- Severe motor and/or sensory neuropathy
- Rheumatologic or orthopedic problem or bone lesions with a fracture risk
- Others comorbidities contra-indicated physical exercises
- Patient protected by the law - Guardianship and trusteeship
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
CHU Morvan
Brest
Hôpital Beaujon
Clichy
Hôpital Henri Mondor
Créteil
Centre Georges François Leclerc
Dijon
CHD Vendée
La Roche-sur-Yon
Institut Hospitalier Franco-Britannique
Levallois-Perret
Centre Léon Bérard
Lyon
CH Saint Joseph Saint Luc
Lyon
Hôpital Européen
Marseille
CH Mont de Marsan
Mont-de-Marsan
Centre Hospitalier de Belfort
Montbéliard
Hôpital Cochin
Paris
Hôpital Saint Antoine
Paris
CHU Robert Debré
Reims
Hôpital FOCH
Suresnes
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy
About this study
Official title: Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.
Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population
Read the detailed description
The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.
The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.
200 randomized patients are required.
The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).
Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.
- Being tested
- without APA program, APA program
- Keywords
- Unresectable, Pancreatic cancer, GERCOR, Adapted physical activity (APA), Quality of life, Fatigue
- Medical subject headings
- Pancreatic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without APA programOther
Control Arm : chemotherapy alone
APA programOther
Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
| Study group | Role | What they receive |
|---|---|---|
| Standard care without APA program | Active comparator | The control arm corresponds to usual care (without APA), including :
* Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol)
* Evaluation by the oncologist at the usual rate
* Assessment every 8 weeks (TAP scan + CA-19.9)
* Nutritional, psychological and pain management as recommended, according to the usual schedule. Receives: Other: without APA program |
| Standard care with APA program | Experimental | The experimental arm corresponds to usual care, combined with a 16-week APA program.
The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner). Receives: Other: APA program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL) at 16 weeks
HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.
Measured: At 16 weeks
Secondary outcomes (16)
Time To deterioration (TTD)
Measured: Up to 24 months
Brief Pain Inventory Short form questionnaire
Measured: Up to 24 months
Patient depression scale - HADS questionnaire
Measured: Up to 24 months
Nutritional status evaluation
Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)
Measured: up to 24 months
Physical Activity evaluation - IPAQ questionnaire
Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program
Measured: up to 24 months
Number of Adverse events (AE) grade 3 -4
Measured: up to 24 months
Progression free survival (PFS)
Measured: 2 years
Overall Survival (OS)
Measured: 2 years
Accompanying partner depression scale (HADS questionnaire)
Measured: up to 24 months
General state - Performance status OMS
Measured: up to 24 months
Fatigue scale (EVA fatigue)
Measured: up to 24 months
MFI-20 and EORTC QLQ C-30 evaluation
Measured: at 6, 12 et 24 months
medico-economic evaluation
Measured: up to 24 months
visual analog scale for pain
Measured: up to 24 months
analgesic consumption
Measured: up to 24 months
anxiolytic / antidepressant consumption
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start20 Nov 2014
- Primary completion21 Apr 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Locally Advanced CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Hammel, MD, Principal investigator, Hôpital Beaujon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184663
- Sponsor's protocol ID
- APACaP D13-1
- Other IDs
- 2014-A00228-39
- Status last verified
- Sep 2023
- First submitted
- 2 Jul 2014
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8.
PubMed 26458923
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02184663
- Acronym / sponsor ID
- APACaP D13-1
- Keywords
- Unresectable, Pancreatic cancer, GERCOR, Adapted physical activity (APA), Quality of life, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 313 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- 20 Nov 2014 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 9 Jul 2014 (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.
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.
Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population
Detailed description
The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.
The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.
200 randomized patients are required.
The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).
Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care without APA program | Active comparator | Other: without APA programThe control arm corresponds to usual care (without APA), including : * Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol) * Evaluation by the oncologist at the usual rate * Assessment every 8 weeks (TAP scan + CA-19.9) * Nutritional, psychological and pain management as recommended, according to the usual schedule. |
| Standard care with APA program | Experimental | Other: APA programThe experimental arm corresponds to usual care, combined with a 16-week APA program. The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven non resectable pancreatic adenocarcinoma
- Indication of palliative chemotherapy
- Life expectancy ≥ 3 months
- Eastern Cooperative oncology group (ECOG) - Performance status ≤2
- Age ≥18 years old
Key exclusion criteria (8 listed)
- Previous Cerebrovascular accident or myocardial infarction <6months
- Uncontrolled hypertension.
- Severe cardiovascular or respiratory disease
- Severe cognitive or psychiatric disorder
- Severe motor and/or sensory neuropathy
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 |
|---|---|---|
| without APA programControl Arm : chemotherapy alone | Other | Standard care without APA program |
| APA programExperimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises) | Other | Standard care with APA program |
Primary outcome
Health-related quality of life (HRQoL) at 16 weeks
Time frame: At 16 weeks
HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.
16 secondary outcomes
Time To deterioration (TTD)
Time frame: Up to 24 months
Brief Pain Inventory Short form questionnaire
Time frame: Up to 24 months
Patient depression scale - HADS questionnaire
Time frame: Up to 24 months
Nutritional status evaluation
Time frame: up to 24 months
Physical Activity evaluation - IPAQ questionnaire
Time frame: up to 24 months
Number of Adverse events (AE) grade 3 -4
Time frame: up to 24 months
Progression free survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Accompanying partner depression scale (HADS questionnaire)
Time frame: up to 24 months
General state - Performance status OMS
Time frame: up to 24 months
Fatigue scale (EVA fatigue)
Time frame: up to 24 months
MFI-20 and EORTC QLQ C-30 evaluation
Time frame: at 6, 12 et 24 months
medico-economic evaluation
Time frame: up to 24 months
visual analog scale for pain
Time frame: up to 24 months
analgesic consumption
Time frame: up to 24 months
anxiolytic / antidepressant consumption
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 26458923Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8.
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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.
Pascal Hammel, MD principal investigator
Hôpital Beaujon
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing without APA program and APA program in people with Unresectable Locally Advanced Cancer and Metastatic Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 17 sites 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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.
Are results available for this study?
Results are not available in the source record.
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?
Health-related quality of life (HRQoL) at 16 weeks (time frame: At 16 weeks). 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 NCT02184663, which also lists 1 linked publication.
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 28 Sep 2023.