Adaptated Physical Activity During Chemotherapy: Evaluation of the Psychological, Physiological and Biological Impact

NCT02785341 | Terminated DMC

• 1 other identifier: APA2-IPC 2014-010
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although treatments significantly increase the life expectancy of cancer patients, their quality of life is more or less reduced. The development of supportive care, such as physical activity, is one of the tools that should be promoted to maintain quality of life and reduce treatment side effects, including fatigue. This study was developed to understand the different biopsychosocial effects of a physical activity program carried out with patients suffering from various types of cancers, and to facilitate and improve the implementation of this type of activity in health care facilities. Study randomized, controlled, cross-over intervention evaluating a 12-week supervised and adapted physical activity program. Participants were assigned to one of two groups: Group A which first follows a 12-week physical activity program, then undergoes usual care for 12 additional weeks, or Group B, which continues usual care for 12 weeks (control group) and then starts the physical activity program for 12 additional weeks. Quality of life (with questionnaires for 2 groups) , well-being, fatigue, physical capacity, leptin concentration, goal setting and level of physical activity are evaluated during this protocol. By understanding the multidimensional effects of a physical activity program for various cancer types, depending on the time of proposing the program, by evaluating the correlations among all these variables, and by evaluating long-term effects, the IPCAPA study contributes to identifying the physical activity program which will be effective, viable and feasible for all patients undergoing chemotherapy, whatever the type of cancer.

Conditions

Cancer

Keywords

adapted physical activity

Outcome Measures

Primary Outcomes (1)

• Impact of physical activity on fatigue during chemotherapy

  Questionnaire MFI 20 (Multidimensional Fatigue Inventory)

  From the inclusion in the protocol until week 24

Secondary Outcomes (2)

• Physiological evaluation

  From the inclusion in the protocol until week 24

• Biological evaluation

  Leptin concentration realized from inclusion (week 1) then week 12 and week 24

Study Arms (2)

Immediate adaptated physical activity (Group A)

OTHER

Group A began a physical activity program for 12 consecutive weeks from inclusion in the protocol, then underwent the usual care for 12 additional weeks. Then to complete five evaluations with several questionnaires, and 6-minute walk test every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4).

Other: questionnaires every 6 weeks (T0, T1, T2, T3 and T4); Other: 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4); Other: leptin level with a blood test every 12 weeks (T0, T2 and T4)

Without immediate adaptated physical activity (Group B)

OTHER

Group B followed the usual care for 12 weeks then started the physical activity program for 12 additional weeks. Then to complete five evaluations with several questionnaires, and 6-minute walk test every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4).

Other: questionnaires every 6 weeks (T0, T1, T2, T3 and T4); Other: 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4); Other: leptin level with a blood test every 12 weeks (T0, T2 and T4)

Interventions

questionnaires every 6 weeks (T0, T1, T2, T3 and T4) OTHER

Questionnaire MFI 20 Questionnaire life satisfaction Scale of measurement of the positive and negative affects Questionnaire QLQ-C30 (EORTC) Questionnaire on the personal goals

Immediate adaptated physical activity (Group A); Without immediate adaptated physical activity (Group B)

6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4) OTHER

Immediate adaptated physical activity (Group A); Without immediate adaptated physical activity (Group B)

leptin level with a blood test every 12 weeks (T0, T2 and T4) OTHER

blood sample

Immediate adaptated physical activity (Group A); Without immediate adaptated physical activity (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or more,
• Performance status (WHO) ≤ 2
• Ability to participate in the IPCAPA program and medical certification of no contraindications to exercise
• Availability and willingness to participate in the IPCAPA study for the duration of the protocol
• Affiliated to a social security system
• Signed informed consent.

You may not qualify if:

• Pregnant or breastfeeding woman.
• Woman with childbirth ability without effective contraception.
• Patient in emergency situations, adult subject to a measure of legal protection (major trusteeship, guardianship or ward of court), or unable to consent.
• Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
• Inability to practice physical activity.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Related Links

• Institut PAOLI-CALMETTES

MeSH Terms

Conditions

Neoplasms

Interventions

Triiodothyronine

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• CAPPIELLO Maria Antonietta, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 27, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 27, 2016

Record last verified: 2016-05