Menopausal Symptoms in Breast Cancer Patients With Treatment-Induced Complaints Clinical Trial
Official title:
Cognitive Behavioral Therapy (CBT) and Physical Exercise for Climacteric Symptoms in Breast Cancer Patients Experiencing Treatment-Induced Menopause: a Multicenter Randomized Trial
Background: Breast cancer is the most common form of cancer among women in the Netherlands.
Approximately 11,000 women are diagnosed with breast cancer annually, of whom about 30% are
below 50 years of age. Premenopausal women with breast cancer treated with chemotherapy or
hormonal therapy may experience a premature onset of the menopause. Estrogen deficiency
following adjuvant treatments leads to primary endocrine symptoms, including vasomotor and
urogenital problems. Secondary symptoms include insomnia due to night sweats, dyspareunia
due to vaginal dryness, weight gain, and psychological distress. The symptoms resulting from
accelerated estrogen withdrawal can be pronounced and severe, and may adversely affect
women's sexual functioning, body image, and overall HRQL. Healthy women who enter natural
menopause are often prescribed hormone replacement therapy (HRT) to alleviate vasomotor and
sexual symptoms. However, due to possible tumor-promoting effects, HRT is contraindicated
for patients with a history of breast cancer. For these women, non-hormonal medications are
frequently prescribed to treat vasomotor symptoms. Although these medications have been
shown to yield moderate symptom relief, they also have a number of bothersome side effects.
To alleviate urogenital symptoms, local vaginal moisturizing or estrogen cream is often
prescribed. There is growing evidence that cognitive behavioral therapy (CBT) including
relaxation techniques, and physical exercise may effectively reduce vasomotor symptoms in
naturally occurring menopause. CBT and relaxation techniques are aimed primarily at the
modification of precipitants of hot flushes and at stress management. Physical exercise on a
regular basis affects neurotransmitters, which regulate central thermoregulation.
Purpose: The proposed study will evaluate the efficacy of a supportive intervention program
in alleviating menopausal symptoms, improving sexual functioning and enhancing the quality
of life of younger women (< 50 years) with breast cancer who have become prematurely
menopausal as a result of their treatment. Specifically, the study will evaluate CBT
including relaxation (A), physical exercise (B), and a combination of A and B.
Plan of investigation: This multicenter study will employ a prospective, full-factorial
design. In total, 325 consenting women will be randomized to group A, group B, group AB or a
usual care, 'waiting list' control group (N = 81-81 per group). Upon completion of the
study, the patients assigned to the control group will be given the opportunity to undergo
either the A or B intervention program. The program will begin with a structured assessment
of the target symptoms: hot flushes, night sweating and vaginal dryness. The overriding goal
of the intervention is to provide symptomatic women with information skills and support to
manage their symptoms more effectively. For group A, the intervention will consist of 6
weekly group CBT sessions of 1.5 hours, of 15 minutes of daily homework and a booster
session at 3 months. The CBT will focus on understanding and self-control of menopausal
symptoms. Relaxation techniques (paced respiration and muscle relaxation) will focus on the
reduction of sympathetic nervous system activity, and are expected to have a positive impact
on the frequency and intensity of hot flushes. For group B, the intervention will be an
individually tailored, 12 week home-based physical exercise program of 2.5-3 hours per week,
with instructions provided in-clinic on 2 occasions, and telephone support on 2 additional,
interim occasions. The physical exercise program is intended to enhance fitness levels, in
general, and to improve thermoregulation specifically related to hot flushes. Group AB will
receive both the CBT and exercise program elements. Women allocated to the intervention
groups will be asked to complete a battery of questionnaires assessing menopausal symptoms
(the primary outcome), sexuality, body- and self-image, psychological distress and generic
HRQL prior to the start of the program (baseline, T0), at 12 weeks (T1) and at 6 months
follow-up (T2). Women allocated to the control group will complete the same questionnaire
battery at parallel points in time.
Results/ relevance: If demonstrated to be effective, the availability of a structured
supportive intervention program (modules A, B or AB) will be a welcome addition to regular
medical care offered to breast cancer patients with treatment-induced menopause. It is
anticipated that such a program will have direct benefit in terms of symptoms relief and the
improvement of patients' HRQL.
n/a
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment