Clinical trial · Interventional
Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer
Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
NCT02184663CI-TRIAL-00069989unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Locally Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APA program | Other | — | UNRESOLVED |
| without APA program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard care without APA program
- description
- 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.
- interventionNames
- Other: without APA program
- type
- EXPERIMENTAL
- label
- Standard care with APA program
- description
- 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).
- interventionNames
- Other: APA program
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * Identified Accompanying partner Adapted Physical Activity (AAPA) * Signed and dated informed consent * Registration in a National Health Care System (CMU included for France) Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDNeuzillet 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. PMID 26458923