跳至主要内容
临床试验/CTRI/2024/03/064573
CTRI/2024/03/064573尚未招募3 期

Optimising adherence with a customised flexible multimodal exercise regimen in prostate cancer patients on radiation and androgen deprivation therapy

Tata Medical Center1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
175
试验地点
1
主要终点
Changes in the Quality of Life as measured by FACIT-F

研究概览

简要总结

Rationale:

Androgen deprivation therapy is an important component of prostate cancer treatment. This acts by reducing the testosterone levels in the body and thereby cutting off the primary factor which is driving prostate cancer growth. However, testosterone in addition to being the sexual hormone it is also needed for several other protective functions in the body. These include maintaining bone strength, muscle strength, cardiovascular safety, maintaining sugar and cholesterol levels etc. Hence, any reduction in testosterone levels leads to side effects related to these factors resulting in metabolic syndromes, bothersome fatigue, loss of muscle power etc. Exercises have been shown to help in reducing many of these side effects including fatigue and improving muscle strength. While supervised exercise sessions are recommended it is difficult for our patients to get access to such facilities and availability of expertise in the community is a concern. In view of this, in standard practice patients are referred to the rehabilitation services for advice on exercises and after that the patients continue these at home.

Novelty:

The present study is looking to leverage the patient’s visit to the hospital for radiation therapy procedures to give them more frequent visits to the rehabilitation services for supervised sessions to improve adherence to the exercise protocol and thereby improve the quality of life of patients.

Aim:

The aim of this study is to test the effectiveness of frequent visits to the rehabilitation services in improving adherence and quality of life of patients on androgen deprivation therapy.

Objectives:

To assess whether more frequent visits to the rehabilitation services for monitoring of the exercises lead to better adherence to exercises and result in better quality of life of the patients. We will assess the difference in the functional status and body composition between the two groups.

Methods: This will be a two-arm prospective randomised controlled, open-label, parallel-group, superiority trial.

Expected outcome: Incorporation of frequent visits to rehabilitation services is likely to result in increased adherence in doing regular exercises and lead to better quality of life in terms of reduction in fatigue levels. There may also be improvements in functional status and body composition measures with the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • Confirmed prostatic carcinoma
  • Will undergo radiation therapy.
  • radical radiation therapy or prostate-directed radiation therapy
  • Is on androgen deprivation therapy with either medical or surgical methods and is planned to be on this for a minimum duration of 6 months
  • ECOG Performance status 0-1
  • Signed study-specific consent form
  • Patient willing and reliable for follow-up.

排除标准

  • Patients should have none of the following
  • ECOG Performance status 2 or more
  • Limitation in mobility and/or comorbidities that will prevent them from complying to exercise requirements
  • Unable to follow up or poor logistic or social support
  • Deemed to be at high risk of harm due to the presence of lytic bone metastases.

结局指标

主要结局

Changes in the Quality of Life as measured by FACIT-F

时间窗: At 24 weeks and at 36 weeks after the start of ADT

次要结局

  • Adherence to the prescribed exercise protocol measured at 24 weeks and at 36 weeks after the start of ADT(At 24 weeks and at 36 weeks after the start of ADT)
  • Changes in the Quality of Life as measured by FACT-G and EORTC - PR25(At 24 weeks and at 36 weeks after the start of ADT)
  • Functional performance of the patients(At 24 weeks and at 36 weeks after the start of ADT)
  • Body Composition of the patients(At 24 weeks and at 36 weeks after the start of ADT)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Moses Arunsingh

Tata Medical Center, Kolkata

研究点 (1)

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