Efficacy of exercise intervention for fatigue of gynecologic cancer patients receiving chemotherapy

JRCT ID: jRCT1031200069

Registered date:16/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cervical cancer, endometrial cancer, ovarian cancer
• Date of first enrollment: 21/07/2020
• Target sample size: 110
• Study type: Interventional
• Intervention(s): We instruct patients to do 30 minutes/day of walking and strength training three times a week at home. And, once every three weeks, patients go to the rehabilitation department for exercise therapy.

Outcome(s)

Primary Outcome

The difference in FACIT-F subscale score before and after treatment
(The difference between the score at 1 month after the end of chemotherapy and the score before the start of chemotherapy)

Secondary Outcome

FACIT-F: Evaluation of scoring after 2 cycles, 4 cycles, 6 cycles of chemotherapy, and immediately after chemotherapy
FACT-G
FACT & GOG-ntx (neurotoxicity subscale of the Functional Assessment of Cancer Therapy/gynecologic Oncology Group)
PSQI (Pittsburgh Sleep Quality Index)
Postponement rate of chemotherapy
MMT/handheld dynamometer muscle strength test (quadriceps, grip strength)
Five times rise test
Six-minute walk test
Body composition: The area of subcutaneous and visceral fat measured by CT
Iliopsoas muscle/skeletal muscle area/volume

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Female

Include criteria

(1) Patients aged 20 to 80 at the time of registration
(2) Patients who are diagnosed with gynecologic cancer (cervical cancer, endometrial cancer, ovarian cancer) and who meet the following requirements.
*Peritoneal cancer and fallopian tube cancer are included in ovarian cancer
*Double cancer among the above gynecologic cancers are allowed.
(3) Patients who will be received tri-weekly TC therapy for the first time as the primary or recurrent treatment. Preoperative chemotherapy is not included. Postoperative adjuvant chemotherapy, remission induction therapy, and recurrent treatment are targeted. Bevacizumab combination with TC therapy is allowed in the ovarian cancer and cervical cancer.
(4) ECOG Performance Status (PS) is 0-2.
(5) Patients who can answer questionnaire surveys
(6) Patients who have signed an approved informed consent to participate in this study

Exclude criteria

(1) Patients who clearly need rehabilitation before the start of treatment due to other diseases or poor general condition
(2) Patients who are considered to be unable to undergo at least two cycles of chemotherapy at least due to complications (intestinal obstruction, thrombosis, etc.) or the progression of the cancer
(3) Patients with other malignant tumors requiring for treatment at the same time (Patients who have a history and are currently in remission are tolerated)
(4) Patients with depression currently under treatment and sleep disorders requiring sleeping pills
(5) Patients with serious heart disease
I) exertional angina ii) severe arrhythmia iii) resting chest pain
Iv) Poor hemodynamics immediately after myocardial infarction
(6) Patients with palpitations or shortness of breath of NYHA III degree or above and chest pain before rehabilitation
(7) Patients who participated clinical trials or clinical trials of drugs or medical devices, etc. within 30 days before inclusion in this study or who may participated in the other clinical trial during this trial.
(8) Patients who are judged to be unsuitable as a subject by the doctor or researcher

Related Information

• Primary Sponsor: Miyagi Etsuko
• Secondary Sponsor: Kamiya Natsuko