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Active, Not Recruiting

NCT Number: NCT03169075

QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program

This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) <3/10), and life expectancy ≥3 months.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Home Based Standardised Adapted Physical Activity Programme Fatigue Pathological Conditions, Signs and Symptoms Patients Taking Oral Targeted Therapy for Metastatic Cancer Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICO Paul Papin, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient's ≥18 years old.
  • Patient treated for a metastatic solid tumour within the following 4 cohorts: breast cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers).
  • Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy.
  • Patients may have been treated with immunotherapy.
  • Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
  • Life expectancy of ≥3 months.
  • ECOG performance status ≤2.
  • Patients able to comply with the constraints of the SPEP protocol.
  • Pain under control (VAS ˂3; 0-10 scale).
  • Haemoglobin level ≥9 g/dL.
  • Patient must have signed the informed consent form before any study-related procedures.
  • Patients must have public health insurance coverage.

Exclusion criteria

  • Patient receiving an injectable targeted therapy.
  • Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
  • Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed).
  • Patient with known risk of fracture, symptomatic cardiac insufficiency (NYHA-3), respiratory insufficiency (grade 3), intense pain not controlled with analgesic treatment, and/or neuropathy (grade 3).
  • Patients with a history of cancer in the last 5 years (except basal cell carcinoma adequately treated and in situ cervical cancer treated and cured).
  • Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg.
  • Bone metastases with risk of fractures.
  • Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule.
  • Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol.
  • Persons deprived of liberty or under guardianship.

Treatment and study plan

Supervised physical exercise programs

Behavioral

A weekly supervised physical activity session of 60 min at the patient's home is planned for 3 months.

These sessions will be supervised by an educator or physiotherapist trained, with respect to the pathology and the clinical study, specifically for this activity (Fédération Française Sport et Cancer) . The proposed exercises will be normalized and adapted to each patient's profile.

Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ, Evaluation by a coach VAE

Adapted Physical Activity

Behavioral

Program based on the recommendations for performing a physical activity. A booklet containing physical activity recommendations will be given to the patients after randomization.

The weekly sessions at the patients home for the experimental group (Program A) must begin as soon as possible within the 15 days after starting oral targeted therapy.

Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ

Primary outcomes

  1. FACT-F relative on Fatigue

    Time frame: Month 3 ( M3)

    Self reported Questionnaires

  2. FACT-G

    Time frame: Month3 ( M3)

    Self Reported Questionnaire relative on Well-Being Patient

Secondary outcomes

  1. PFS

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 75 months

    Progression Free Survival

  2. OS

    Time frame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months

    Overall Survival

  3. Quality of life

    Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

    Self reported Questionnaire on quality of life

  4. Fatigue

    Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

    Self reported Questionnaire FACT-F on Fatigue

  5. Fatigue

    Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

    visual analogic scale for fatigue

  6. Pain

    Time frame: Month 1, Month 2, Month 3, and every 3 months for 1 year

    visual analogic scale for pain (VAS)

  7. Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )

    Time frame: Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

  8. Compliance about oral targeted therapy

    Time frame: Baseline, Month 1, Month 2, Month 3

    Self reported Questionnaire Morisky-Green

  9. Benefit of physical activity: walk

    Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

    6 minutes walking test

  10. Benefit of physical activity muscle function

    Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

    muscle function

  11. Benefit of physical activity muscle strength

    Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

    muscle strength

  12. Physical Activity IPAQ

    Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

    self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)

  13. Physical Activity, Body Mass Index

    Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

    Body Mass Index

  14. Scores of anxiety and depression

    Time frame: Baseline, Month 1, Month 2, Month 3

    Hospital Anxiety and Depression Scale (HADs)

  15. Cognitive functions

    Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

    Self reported questionnaire FACT-Cog

  16. Evaluation of Ingesta, Anorexia

    Time frame: Baseline, Month 3

    Ingesta

  17. Evaluation of Ingesta, VAS

    Time frame: Baseline, Month 3

    VAS

  18. Evaluation of Anorexia

    Time frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

    Self reported FAACT (module A-C)

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

  • CAMI: Sport & Cancer

Registry information

Official study title

Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study

Acronym: QUALIOR

Important dates

Study start
2017
Primary completion
2024
Study completion
2028
First posted
May 30, 2017
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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